METHOD, APPARATUS AND KIT FOR TREATING CHRONIC AND LONG-TERM NASAL CONGESTION

Abstract

A method of treating episodic and chronic nasal congestion of the human nasal passages is disclosed. The present invention combines use of decongestant nasal spray, saline nasal spray, and nasal dilator therapies with minimized risk of incurring rebound congestion. The method may be used as both preventative and withdrawal therapies for patients experiencing rebound congestion. Nasal dilators, decongestant nasal spray and saline nasal spray are provided in kit form whereby users may practice the method.

Claims

1.-28. (canceled)

29. A nasal congestion treatment kit, comprising: at least one first nasal-spray apparatus for administering a pharmaceutically-inactive solution as a spray mist into a nasal passage of a human nose; at least one second nasal-spray apparatus for administering a measured amount of a pharmaceutically-active solution as a spray mist into said nasal passage; and at least one nasal dilator, wherein said pharmaceutically-active solution is an aqueous solution comprising not less than 0.002% and not more than 0.02% of a pharmaceutically-active ingredient by weight.

30. The nasal congestion treatment kit of claim 29, wherein: each second nasal-spray apparatus is configured such that emission of an effective dose of said pharmaceutically-active solution as a spray mist requires at least one full actuation of the respective second nasal-spray apparatus, and each second nasal-spray apparatus is configured such that emission of an effective dose of said pharmaceutically-active solution as a spray mist requires not more than three full actuations of the respective second nasal-spray apparatus.

31. The nasal congestion treatment kit of claim 29, wherein: said at least one nasal dilator consists of M nasal dilators, said at least one second nasal-spray apparatus contain, in total, N effective doses of said pharmaceutically-active solution, M is not more than 4* N, and M is not less than N/2.

32. The nasal congestion treatment kit of claim 29, wherein: each first nasal-spray apparatus is configured such that a single full actuation of the respective first nasal-spray apparatus effects emission of a first amount of said pharmaceutically-inactive solution as a spray mist, and said first amount is at least five times said measured amount and less than twenty times said measured amount.

33. The nasal congestion treatment kit of claim 29, wherein: an effective dose of said pharmaceutically-active solution comprises not less than 1 μg and not more than 10 μg of said pharmaceutically-active ingredient.

34. The nasal congestion treatment kit of claim 29, wherein: 25 said pharmaceutically-active ingredient is selected from the group consisting of Oxymetazoline, Phenylephrine and Xylometazoline.

35. The nasal congestion treatment kit of claim 29, wherein: said pharmaceutically-inactive solution is an aqueous solution comprising a salt selected from the group consisting of sodium chloride and potassium chloride, and said pharmaceutically-inactive solution comprises not less than 0.5% and not more than 0.8% of said salt per weight.

36. A nasal congestion treatment kit, comprising: a nasal-spray apparatus for administering a measured amount of an aqueous solution as a spray mist into a nasal passage of a human nose; and at least one nasal dilator, wherein said aqueous solution comprises a salt selected from the selected from the group consisting of sodium chloride and potassium chloride, said aqueous solution comprises not less than 0.002% and not more than 0.02% of a pharmaceutically-active ingredient by weight, and said pharmaceutically-active ingredient is a sympathomimetic vasoconstrictor.

37. The nasal congestion treatment kit of claim 36, wherein: said nasal-spray apparatus is configured such that emission of an effective dose of said aqueous solution as a spray mist requires at least one full actuation of said nasal-spray apparatus, and said nasal-spray apparatus is configured such that emission of an effective dose of said aqueous solution as a spray mist requires not more than three full actuations of said nasal-spray apparatus.

38. The nasal congestion treatment kit of claim 36, wherein: said at least one nasal dilator consists of M nasal dilators, said nasal-spray apparatus contains, in total, N effective doses of said aqueous solution, M is less then 4* N, and M is greater than N/2.

39. The nasal congestion treatment kit of claim 36, wherein: said at least one nasal dilator is a plurality of external nasal dilators, each suitable for dilating a region of said nasal passage when applied to an external surface of said human nose.

40. The nasal congestion treatment kit of claim 36, wherein: an effective dose of said aqueous solution comprises not less than 1 μg and not more than 10 μg of said pharmaceutically-active ingredient.

41. The nasal congestion treatment kit of claim 36, wherein: said pharmaceutically-active ingredient is selected from the group consisting of Oxymetazoline, Phenylephrine and Xylometazoline.

42. The nasal congestion treatment kit of claim 36, wherein: said aqueous solution comprises not less than 0.5% and not more than 0.8% of said salt per weight.

43. A method comprising: dispensing an aqueous solution into a receptacle, and assembling said receptacle to an atomizing mechanism to obtain a nasal-spray apparatus for administering a portion of said aqueous solution as a spray mist into a nasal passage of a human nose, wherein said aqueous solution comprises not less than 0.002% and not more than 0.02% of an pharmaceutically-active ingredient by weight, and said pharmaceutically-active ingredient is a sympathomimetic vasoconstrictor.

44. The method of claim 43, wherein: said aqueous solution comprises a salt selected from the selected from the group consisting of sodium chloride and potassium chloride.

45. The method of claim 43, wherein: packaging said nasal-spray apparatus with at least one nasal dilator.

46. The method of claim 43, wherein: packaging said nasal-spray apparatus with a second nasal-spray apparatus and at least one nasal dilator, wherein said second nasal-spray apparatus comprises a reservoir of pharmaceutically-inactive solution and is configured for administering a portion of said pharmaceutically-inactive solution as a spray mist into said nasal passage.

47. The method of claim 43, wherein: said pharmaceutically-active ingredient is selected from the group consisting of Oxymetazoline, Phenylephrine and Xylometazoline.

48. The method of claim 43, wherein: said aqueous solution comprises a salt selected from the selected from the group consisting of sodium chloride and potassium chloride, said aqueous solution comprises not less than 0.5% and not more than 0.8% of said salt per weight.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0020] FIG. 1 is a side view of a human nose shown as a portion of a human face with a cross-sectional representation by stippling of the nasal passages thereof.

[0021] FIG. 2 is a perspective view of the human nose depicted in FIGS. 1 and 3, showing by stippling a cross-sectional representation of the nasal valve area.

[0022] FIG. 3 is an underside elevational view of the human nose depicted in FIG. 1.

[0023] FIG. 4 is a perspective view of a human nose showing an END applied thereon.

[0024] FIG. 5 is a plan view of labeling for oxymetazoline-based OTC decongestant nasal spray.

[0025] FIG. 6 illustrates articles as may be found in a kit, in accordance with the present invention, for use in treating long-term or chronic nasal congestion.

[0026] FIG. 7 is a perspective view of a human nose showing an END applied thereon.

DETAILED DESCRIPTION

[0027] Several views of a human nose, 10, are shown in FIGS. 1-3. Stippling bounded by dashed lines in FIG. 1 depicts an approximate cross-sectional rendering of the nasal passages extending from the nostril opening, 18, to the back of the throat. The nasal passages of nose 10 comprise an anterior region, also known as the nasal vestibule, 20, extending from nostril opening (or external nasal valve), 18, to the internal nasal valve area, 30, and a posterior region, 40, extending beyond nasal valve area 30. Arcuate broken lines delineate approximate boundaries between the anterior and posterior regions and the nasal valve area. Dark dashed lines in FIG. 2 more specifically depict nasal valve area 30 as an inverted cone-shape (illustrated on only one side of the nasal septum). For additional perspective, FIG. 2 also illustrates the upper lateral cartilage, 12, and the nasal bone, 14. FIG. 3 also shows, by stippling bounded by dashed lines, a cross-section of nasal valve area 30 from a direction perpendicular to that shown in FIG. 1. It is noted that the nasal passages are narrower at nasal valve area 30 compared to at nostril opening 18.

[0028] FIG. 4 shows a generic END, 110, in use on nose 10. Using a nasal dilator is not strictly required for the present invention, but is most preferred for reasons described herein. Additionally, an END is most preferred over an internal nasal dilator of any type (not shown), since the very presence of an internal nasal dilator within the nasal passages increases airway resistance thereat. The general construction and range of spring biasing force provided by END 110 is preferably consistent with widely commercially available nasal dilators. However, as described hereinbefore, END 110 primarily acts on nasal valve area 30 of the nasal passages, and, depending on how it is constructed, may act on substantial portions of anterior region 20 thereof, as well as portions extending slightly into posterior region 40 thereof. The END art is continually advancing; exemplary of an END that acts on portions of the nasal passages above and below the nasal valve is disclosed, for example, in U.S. Pat. No. 10,893,971 incorporated by reference herein. It is believed that an END, 120, of this type has a greater beneficial effect on the present method than does generic END 110, and a far greater effect than an internal nasal dilator. Applying a nasal dilator may be performed at any point in the sequence of steps, but is most preferably applied prior to administering a first nasal spray, as described hereinbelow. As noted herein, inhaled nasal sprays act primarily on posterior region 40.

[0029] Instructions for administering nasal spray via a squeeze bottle or pump actuator on oneself, or for administration to patients by a health professional, are published online, for example, by the University of Illinois-Chicago Drug Information Group (https://www.healthline.com/health/general-use/how-to-use-nasal-spray), the entirety of which is incorporated by reference herein. An END is applied by centering it horizontally along the centerline of the bridge of the nose, and vertically substantially over nasal valve area 30. Depending on its width, the END may extend partially over nasal vestibule 20 adjacent the nasal valve.

[0030] The step of applying an END notwithstanding, a user actuates a first spray apparatus and inhales a first spray mist of a first aqueous solution into at least one nostril opening of the nose. The first aqueous solution comprises sodium chloride and water in a saline solution, as may be found in the art, suitable for inhaling into the nasal passages, and which acts to thin and loosen mucous deposits within posterior region 40 thereof. The total mist volume administered, whether from one actuation or a plurality of actuations, is unrestricted, but is preferably at least significantly greater than the prescribed volume administered from the second aqueous solution. This may vary substantially from user to user, and even from use to use. However, a suitable starting ratio between the first and second spray mists, for example, may be roughly an order of magnitude. That is, a total mist plume volume of about 100 microliters (μ1) from the first spray mist (whether by a single emitted plume or plurality thereof) may correspond to roughly 10 μl from the second spray mist. The administered volume of the first aqueous solution may be otherwise user-determined.

[0031] The first spray apparatus may comprise a plastic squeeze bottle (not shown), a metered dose spray pump, 112, or a pressurized metal spray canister, 114, as seen, for example, in FIG. 6. The spray mist volume from a squeeze bottle may vary depending on how firmly it is squeezed, and may thus require some repetition in order to deliver a suitable or desired amount of saline mist. However, spray canister 114 delivers a continuous mist plume or liquid spray for as long as the actuator is depressed, and is thus most preferred. For example, one actuation may be sustained for the duration of one long, sharp, nasal inhalation, resulting in a substantial and significant emitted volume of spray or mist, which may more easily correspond to the aforementioned order of magnitude.

[0032] The user next actuates a second spray apparatus and inhales a second spray mist of a second aqueous solution into the at least one nostril opening. The second aqueous solution includes therein a pharmaceutically-active ingredient in the form of a sympathomimetic vasoconstrictor, most preferably oxymetazoline HCl. Inactive ingredients of the second aqueous solution are consistent with that widely found in the prior art.

[0033] The second spray apparatus most preferably comprises a spray pump, as may be provided, for example, by Aptargroup (Congers, N.Y.). The second aqueous solution is most preferably regulated or restricted by configuration of the spray apparatus and/or by the amount or proportion of the pharmaceutically-active ingredient relative, by weight, to the volume of aqueous solution. For example, the second spray apparatus mechanism (pump or orifice) may be configured to deliver a smaller mist plume volume than typically found in OTC nasal decongestants, and thus deliver a fraction of the therapeutically recommended dose thereof. Additionally, or alternatively, the second aqueous solution may contain a lesser concentration of the pharmaceutically-active ingredient than that typically found in OTC nasal decongestants, and thus deliver a fraction of the recommended dose thereof.

[0034] Widely available OTC nasal decongestant sprays in a squeeze bottle or spray pump typically comprise oxymetazoline HCl 0.05% by weight/volume. A single full upright actuation (squeeze or plunge) is believed to deliver a 28.9±6.8 μl mist plume (28,900±6,800 micrograms), thus including therein about 14.45±3.4 micrograms (mcg) of oxymetazoline (0.05% by weight thereof). As seen in FIG. 5, the therapeutically recommended dose for OTC oxymetazoline-based decongestant nasal sprays is 2-3 such actuations, for a total of about 29 to 43 mcg of oxymetazoline.

[0035] The smallest effective fractional dose of pharmaceutically-active ingredient, in accordance with the present invention, is in a range that may vary from user to user and use to use. A preferred range of pharmaceutically-active ingredient is estimated to be between about 1 mcg and roughly 10 mcg, a more preferred range may be from about 2 mcg to about 8 mcg, and a still more preferred range may be from about 3 mcg to about 6 mcg. Again, the unexpected result of the present invention is that so little pharmaceutically-active ingredient may be effective when combined with a comparably voluminous application of saline spray.

[0036] In any case, the user is cautioned to use no more than a predetermined number of sprays corresponding to the aforementioned preferred range. For example, where the second spray apparatus is configured to emit a 30 μl (30,000 mcg) plume per actuation, including therein the pharmaceutically-active ingredient at 0.005% by weight, the user would administer 1.5 mcg of the vasoconstrictor per actuation. According to an embodiment the user may thus conveniently administer a suitable dose with one, two or three spray actuations (1.5, 3.0, or 4.5 mcg, respectively). Beneficially, this is similar to the number of actuations that the user may already be accustomed to in using widely available OTC nasal decongestant sprays. Thus, an embodiment may comprise a standard sympathomimetic vasoconstrictor in its standard packaging, but at a substantially diluted concentration (0.005% by weight), well below the concentrations typically expected to be therapeutically effective (0.05% by weight).

[0037] It will be apparent to one or ordinary skill in the art that the second spray apparatus and the second aqueous solution may have a variety of configurations/concentrations relative to each other while remaining within the preferred range of the pharmaceutically-active ingredient administered.

[0038] Alternatively, the second spray apparatus may be selected from typical widely available OTC nasal decongestant sprays having a squeeze bottle or spray pump apparatus comprising oxymetazoline HCl 0.05%. However, for purposes of the present method, the user must carefully actuate the apparatus less firmly so as to deliver a lesser volume of spray mist, and thus a lesser amount of oxymetazoline from a single actuation, than that for which the spray apparatus is configured. A partial single plunge may thus deliver a mist plume in a range, for example, of from about 5 μl (5,000 micrograms) to about 20 μl (20,000 micrograms), including therein from about 2.5 mcg to about 10 mcg of oxymetazoline (0.05% thereof). Though less precise, this alternative step has been found to be workable.

[0039] Further alternatively, the first and second spray mists may be combined to form a single aqueous solution administered from a single spray mist or atomizer apparatus. Active ingredients of the combined aqueous solution consist essentially of, for example, a salt such as sodium chloride or potassium chloride, present in a suitable range, most preferably 0.65% by weight. The concentration of sympathomimetic vasoconstrictor is typically present as the hydrochloride salt of the compound, e.g., oxymetazoline HCl, at a low concentration such that a single full actuation delivers preferably from about 0.5 mcg to about 2 mcg of oxymetazoline. The single spray apparatus is preferably configured to emit a mist plume greater than about 30 μl, so that actuation could be repeated several times without exceeding the preferred range of the pharmaceutically-active ingredient administered. Again, it may be apparent to one skilled in the art that a range of alternative vasoconstrictor concentrations / mist plume volumes may be workable. Inactive ingredients for the combined aqueous solution may be selected from among those as may be typically found in saline nasal sprays and oxymetazoline-based decongestant nasal sprays, said inactive ingredients being substantially similar. For example, the aqueous solution may also include a bactericide, a fungicide, and/or a preservative. This alternative “all-in-one” medicament administration apparatus may be easier and more convenient for the user, and a more practical product offering in the retail marketplace. It may also be apparent to one skilled in the art that, if needed, a user may still administer additional saline nasal spray from a separate, dedicated spray apparatus such as spray cannister 114.

[0040] After administering nasal spray—either by first and second sprays or a combined spray—the user delays for a period of from about five minutes to about twenty minutes, preferably in the supine position, to allow the first and second spray mists, enhanced by the nasal dilator, to take effect. The supine position better allows drainage down the back of the throat. At the end of the delaying period, the state of congestion is re-assessed, and some or all previous steps may be repeated. However, it is believed that the effect on nasal congestion may be substantially similar to the instantaneous effect of a recommended dose of a sympathomimetic vasoconstrictor decongestant nasal spray used alone, further repetition thus being unnecessary.

[0041] The user may repeat the inventive method, most preferably no more than once daily, but permissibly for more than three consecutive days or nights, wherein a risk of rebound congestion or rhinitis medicamentosa is at least substantially reduced.

[0042] An example of situational implementation of the inventive method and results therefrom may be as follows: A user applies an END at bedtime. Asleep on one side, the user is later awakened by substantial congestion of the nasal passage on the ‘low’ side, perhaps the result of the natural Nasal Cycle, perhaps exacerbated by mild pathological cause. The user sits upright, administers first and second nasal sprays (or a combined spray) into the congested nasal passage, as described herein, and lays back down in the supine position. Some partial decongestion occurs within several minutes, more pronounced decongestion some minutes thereafter accompanied by an urge to inhale sharply with post nasal drainage and substantial nasal clearing. Returning to the one side, the user senses substantial airflow improvement and returns to sleep. The treated nasal passage remains in a decongested state for the remainder of the sleep cycle, regardless of which side the user lays on.

[0043] As further seen in FIG. 6, a kit, 100, for treating nasal congestion using the present method comprises at least one aqueous solution in a spray apparatus, as described hereinbefore, and at least one nasal dilator. An END as described herein is preferred; a plurality thereof may, for example, correspond approximately to the number of metered doses of the second nasal spray apparatus. The kit may further include instructions for administering first and second or combined nasal spray mists, as described herein, and instructions for applying a nasal dilator.

[0044] A nasal-congestion treatment kit according to this embodiment may be co-packaged into a fitted container, not shown, where each component is arranged in order of use according to an embodiment. The instruction guide may be color-coded or otherwise presented to facilitate the user's correct execution of the method. Further, refill components may be provided to replace any individual component that has been exhausted through previous uses. The extra spray apparatus (saline spray, pharmaceutically-active spray, or combination spray apparatus) and the plurality of nasal dilators may be packaged to conform to the kit container.

[0045] The applications of the present invention have been described largely by reference to specific examples and in terms of particular allocations of functionality to certain physical components or collections of components. However, those of skill in the art will recognize that nasal congestion can also be treated effectively with a reduced risk of causing rebound congestion or rhinitis medicamentosa by apparatus and kits that distribute the functions of embodiments of this invention differently than herein described. Such variations and implementations are understood to be captured according to the following claims.

[0046] The preceding disclosure may be summarized, inter alia, as follows:

Embodiment 1

[0047] A nasal congestion treatment kit, comprising:

[0048] at least one first nasal-spray apparatus for administering a pharmaceutically-inactive solution as a spray mist into a nasal passage of a human nose;

[0049] at least one second nasal-spray apparatus for administering a measured amount of a pharmaceutically-active solution as a spray mist into said nasal passage; and

[0050] at least one nasal dilator.

Embodiment 2

[0051] The nasal congestion treatment kit of Embodiment 1, wherein:

[0052] an amount of said pharmaceutically-active solution not less than one half said measured amount and not greater than five times said measured amount constitutes an effective dose of said pharmaceutically-active solution.

Embodiment 3

[0053] The nasal congestion treatment kit of Embodiment 1 or 2, wherein:

[0054] an amount of said pharmaceutically-active solution not less than said measured amount and not greater than three times said measured amount constitutes an effective dose of said pharmaceutically-active solution.

Embodiment 4

[0055] The nasal congestion treatment kit of any one of Embodiments 1-3, wherein:

[0056] each second nasal-spray apparatus is configured such that emission of an effective dose of said pharmaceutically-active solution as a spray mist requires at least one full actuation of the respective second nasal-spray apparatus.

Embodiment 5

[0057] The nasal congestion treatment kit of any one of Embodiments 1-4, wherein:

[0058] each second nasal-spray apparatus is configured such that emission of an effective dose of said pharmaceutically-active solution as a spray mist requires not more than three full actuations of the respective second nasal-spray apparatus.

Embodiment 6

[0059] The nasal congestion treatment kit of any one of Embodiments 1-5, wherein:

[0060] said at least one nasal dilator consists of M nasal dilators,

[0061] said at least one second nasal-spray apparatus contain, in total, N effective doses of said pharmaceutically-active solution,

[0062] M is not more than 4×N, and

[0063] M is not less than N ±2.

Embodiment 7

[0064] The nasal congestion treatment kit of Embodiment 6, wherein:

[0065] M is not more than 2×N.

Embodiment 8

[0066] The nasal congestion treatment kit of any one of Embodiments 1-7, wherein:

[0067] said at least one nasal dilator is a plurality of external nasal dilators, each suitable for dilating a region of said nasal passage when applied to an external surface of said human nose.

Embodiment 9

[0068] The nasal congestion treatment kit of any one of Embodiments 1-8, wherein:

[0069] each first nasal-spray apparatus comprises a first reservoir of said pharmaceutically-inactive solution.

Embodiment 10

[0070] The nasal congestion treatment kit of any one of Embodiment 9, wherein:

[0071] each first nasal-spray apparatus is configured such that a single full actuation of the respective first nasal-spray apparatus transports a first amount of said pharmaceutically-active solution from said first reservoir and effects emission of said first amount of said pharmaceutically-inactive solution as a spray mist, and

[0072] said first amount is at least five times said measured amount and less than twenty times said measured amount.

Embodiment 11

[0073] The nasal congestion treatment kit of any one of Embodiments 1-9, wherein:

[0074] each first nasal-spray apparatus is configured such that a single full actuation of the respective first nasal-spray apparatus effects emission of a first amount of said pharmaceutically-inactive solution as a spray mist, and

[0075] said first amount is at least five times said measured amount and less than twenty times said measured amount.

Embodiment 12

[0076] The nasal congestion treatment kit of Embodiment 11, wherein:

[0077] said first amount is at least eight times said measured amount and less than twelve times said measured amount.

Embodiment 13

[0078] The nasal congestion treatment kit of any one of Embodiments 1-12, wherein:

[0079] each second nasal-spray apparatus comprises a second reservoir of said pharmaceutically-active solution.

Embodiment 14

[0080] The nasal congestion treatment kit of Embodiment 13, wherein:

[0081] each second nasal-spray apparatus is configured such that a single full actuation of the respective second nasal-spray apparatus transports said measured amount of said pharmaceutically-active solution from said second reservoir and effects emission of said measured amount of said pharmaceutically-active solution as a spray mist.

Embodiment 15

[0082] The nasal congestion treatment kit of any one of Embodiments 1-13, wherein:

[0083] each second nasal-spray apparatus is configured such that a single full actuation of the respective second nasal-spray apparatus effects emission of said measured amount of said pharmaceutically-active solution as a spray mist.

Embodiment 16

[0084] The nasal congestion treatment kit of any one of Embodiments 1-15, wherein:

[0085] said pharmaceutically-active solution is an aqueous solution comprising not less than 0.002% and not more than 0.02% of a pharmaceutically-active ingredient by weight.

Embodiment 17

[0086] The nasal congestion treatment kit of any one of Embodiments 1-16, wherein:

[0087] said pharmaceutically-active solution comprises not less than 0.004% and not more than 0.008% of a pharmaceutically-active ingredient by weight.

Embodiment 18

[0088] The nasal congestion treatment kit of any one of Embodiments 1-17, wherein:

[0089] an effective dose of said pharmaceutically-active solution comprises not less than 1 μg and not more than 10 μg of a pharmaceutically-active ingredient.

Embodiment 19

[0090] The nasal congestion treatment kit of any one of Embodiments 1-18, wherein:

[0091] an effective dose of said pharmaceutically-active solution comprises not less than 3 μg and not more than 6 μg of a pharmaceutically-active ingredient.

Embodiment 20

[0092] The nasal congestion treatment kit of any one of Embodiments 1-19, wherein:

[0093] said pharmaceutically-active solution comprises a sympathomimetic vasoconstrictor as a pharmaceutically-active ingredient.

Embodiment 21

[0094] The nasal congestion treatment kit of any one of Embodiments 16-20, wherein:

[0095] said pharmaceutically-active ingredient is selected from the group consisting of Oxymetazoline, Phenylephrine and Xylometazoline.

Embodiment 22

[0096] The nasal congestion treatment kit of any one of Embodiments 1-21, wherein:

[0097] said pharmaceutically-inactive solution is an aqueous solution comprising a salt selected from the group consisting of sodium chloride and potassium chloride.

Embodiment 23

[0098] The nasal congestion treatment kit of Embodiment 22, wherein:

[0099] said pharmaceutically-inactive solution comprises not less than 0.5% and not more than 0.8% of said salt per weight.

Embodiment 24

[0100] The nasal congestion treatment kit of Embodiment 22 or 23, wherein:

[0101] said pharmaceutically-inactive solution comprises not less than 0.6% and not more than 0.7% of said salt per weight.

Embodiment 25

[0102] The nasal congestion treatment kit of any one of Embodiments 1-24, comprising at least two first nasal-spray apparatus.

Embodiment 26

[0103] The nasal congestion treatment kit of any one Embodiments 1-25, comprising at least two second nasal-spray apparatus.

Embodiment 27

[0104] A nasal congestion treatment kit, comprising:

[0105] a nasal-spray apparatus for administering a measured amount of an aqueous solution as a spray mist into a nasal passage of a human nose; and

[0106] at least one nasal dilator, wherein

[0107] said aqueous solution comprises a salt selected from the selected from the group consisting of sodium chloride and potassium chloride,

[0108] said aqueous solution comprises not less than 0.002% and not more than 0.02% of a pharmaceutically-active ingredient by weight, and

[0109] said pharmaceutically-active ingredient is a sympathomimetic vasoconstrictor.

Embodiment 28

[0110] The nasal congestion treatment kit of Embodiment 27, wherein:

[0111] an amount of said aqueous solution not less than one half said measured amount and not greater than five times said measured amount constitutes an effective dose of said aqueous solution.

Embodiment 29

[0112] The nasal congestion treatment kit of Embodiment 27 or 28, wherein:

[0113] an amount of said aqueous solution not less than said measured amount and not greater than three times said measured amount constitutes an effective dose of said aqueous solution.

Embodiment 30

[0114] The nasal congestion treatment kit of any one of Embodiments 27-29, wherein:

[0115] said nasal-spray apparatus is configured such that emission of an effective dose of said aqueous solution as a spray mist requires at least one full actuation of said nasal-spray apparatus.

Embodiment 31

[0116] The nasal congestion treatment kit of any one of Embodiments 27-30, wherein:

[0117] said nasal-spray apparatus is configured such that emission of an effective dose of said aqueous solution as a spray mist requires not more than three full actuations of said nasal-spray apparatus.

Embodiment 32

[0118] The nasal congestion treatment kit of any one of Embodiments 27-31, wherein:

[0119] said at least one nasal dilator consists of M nasal dilators,

[0120] said nasal-spray apparatus contains, in total, N effective doses of said aqueous solution,

[0121] M is less than 4×N, and

[0122] M is greater than N ±2.

Embodiment 33

[0123] The nasal congestion treatment kit of Embodiment 32, wherein:

[0124] M is less than 2×N.

Embodiment 34

[0125] The nasal congestion treatment kit of any one of Embodiments 27-33, wherein:

[0126] said at least one nasal dilator is a plurality of external nasal dilators, each suitable for dilating a region of said nasal passage when applied to an external surface of said human nose.

Embodiment 35

[0127] The nasal congestion treatment kit of any one of Embodiments 27-34, wherein:

[0128] said nasal-spray apparatus comprises a reservoir of said aqueous solution.

Embodiment 36

[0129] The nasal congestion treatment kit of any one of Embodiments 27-35, wherein:

[0130] said nasal-spray apparatus is configured such that a single full actuation of said nasal-spray apparatus transports said measured amount of said aqueous solution from said reservoir and effects emission of said measured amount of said aqueous solution as said spray mist.

Embodiment 37

[0131] The nasal congestion treatment kit of any one of Embodiments 27-35, wherein:

[0132] said nasal-spray apparatus is configured such that a single full actuation of said second nasal-spray apparatus effects emission of said measured amount of said aqueous solution as said spray mist.

Embodiment 38

[0133] The nasal congestion treatment kit of any one of Embodiments 27-37, wherein:

[0134] said aqueous solution comprises not less than 0.004% and not more than 0.008% of said pharmaceutically-active ingredient by weight.

Embodiment 39

[0135] The nasal congestion treatment kit of any one of Embodiments 27-38, wherein:

[0136] an effective dose of said aqueous solution comprises not less than 1 μg and not more than 10 μg of said pharmaceutically-active ingredient.

Embodiment 40

[0137] The nasal congestion treatment kit of any one of Embodiments 27-39, wherein:

[0138] an effective dose of said aqueous solution comprises not less than 3 μg and not more than 6 μg of said pharmaceutically-active ingredient.

Embodiment 41

[0139] The nasal congestion treatment kit of any one of Embodiments 27-40, wherein:

[0140] said pharmaceutically-active ingredient is selected from the group consisting of Oxymetazoline, Phenylephrine and Xylometazoline.

Embodiment 42

[0141] The nasal congestion treatment kit of any one of Embodiments 27-41, wherein:

[0142] said aqueous solution comprises not less than 0.5% and not more than 0.8% of said salt per weight.

Embodiment 43

[0143] The nasal congestion treatment kit of any one of Embodiments 27-42, wherein:

[0144] said pharmaceutically-inactive solution comprises not less than 0.6% and not more than 0.7% of said salt per weight.

Embodiment 44

[0145] A method comprising:

[0146] dispensing an aqueous solution into a receptacle, and

[0147] assembling said receptacle to an atomizing mechanism to obtain a nasal-spray apparatus for administering a portion of said aqueous solution as a spray mist into a nasal passage of a human nose, wherein

[0148] said aqueous solution comprises not less than 0.002% and not more than 0.02% of a pharmaceutically-active ingredient by weight, and

[0149] said pharmaceutically-active ingredient is a sympathomimetic vasoconstrictor.

Embodiment 45

[0150] The method of Embodiment 44, wherein:

[0151] said aqueous solution comprises a salt selected from the selected from the group consisting of sodium chloride and potassium chloride.

Embodiment 46

[0152] The method of Embodiment 44 or 45, comprising:

[0153] packaging said nasal-spray apparatus with at least one nasal dilator.

Embodiment 47

[0154] The method of Embodiment 44, comprising:

[0155] packaging said nasal-spray apparatus with a second nasal-spray apparatus and at least one nasal dilator, wherein

[0156] said second nasal-spray apparatus comprises a reservoir of pharmaceutically-inactive solution and is configured for administering a portion of said pharmaceutically-inactive solution as a spray mist into said nasal passage.

Embodiment 48

[0157] The method of Embodiment 47, wherein:

[0158] said pharmaceutically-inactive solution is an aqueous solution comprising a salt selected from the group consisting of sodium chloride and potassium chloride.

Embodiment 49

[0159] The method of Embodiment 48, wherein:

[0160] said pharmaceutically-inactive solution comprises not less than 0.5% and not more than 0.8% of said salt per weight.

Embodiment 50

[0161] The method of any one of Embodiments 46-49, wherein:

[0162] said at least one nasal dilator is a plurality of external nasal dilators, each suitable for dilating a region of said nasal passage when applied to an external surface of said human nose.