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| ID | Type | Description | Link |
|---|---|---|---|
| SING-US-60-04 |
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Difficulty in recruitment
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray. The purpose of this study is to see if these patients are helped by adding another medication (montelukast) to their treatment compared to placebo (a substance that looks like the active medication but does not contain the drug).
Clinicians frequently prescribe an oral H1 antihistamine for allergic rhinitis patients with residual symptoms after taking an intranasal steroid. Surprisingly, the only studies investigating this combination of drugs have failed to show added efficacy of the H1 receptor over the intranasal steroids alone. Adding montelukast, a leukotriene receptor antagonist, to an intranasal steroid has not been studied in a placebo controlled fashion. Wilson and colleagues, in an open study of patients with chronic rhinosinusitis, showed a benefit of adding montelukast.
The investigators would like to recruit perennially allergic subjects and place them on fluticasone for 2 weeks. Those subjects with residual symptoms would then be randomized to receive either placebo or montelukast in addition to continuing the fluticasone for an additional 2 weeks.
A positive study would support clinical practice and would serve as a preemptive strike against managed care plans that would not allow prescriptions for both drugs.
Hypothesis:
The addition of montelukast to treatment of a perennially allergic subject with an intranasal steroid is more effective at relieving symptoms than a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone propionate + Placebo | Placebo Comparator | Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Placebo - 10 mg po daily for 2 weeks |
|
| Fluticasone propionate + Montelukast | Active Comparator | Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Montelukast - 10 mg po daily for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Montelukast |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period | Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. | Baseline and 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period | Patients recorded the severity of sneezing twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The sneezing symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6. The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Naclerio, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11721504 | Background | Wilson AM, White PS, Gardiner Q, Nassif R, Lipworth BJ. Effects of leukotriene receptor antagonist therapy in patients with chronic rhinosinusitis in a real life rhinology clinic setting. Rhinology. 2001 Sep;39(3):142-6. | |
| 14982509 | Background | Kurowski M, Kuna P, Gorski P. Montelukast plus cetirizine in the prophylactic treatment of seasonal allergic rhinitis: influence on clinical symptoms and nasal allergic inflammation. Allergy. 2004 Mar;59(3):280-8. doi: 10.1046/j.1398-9995.2003.00416.x. |
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Those having residual symptoms (total nasal symptom score of 4+) after the open-label phase were randomized to montelukast or placebo for another two weeks in addition to fluticasone propionate. Of the 102 subjects in open-label phase, 54 with residual symptoms were randomized and are listed as "completed" in open-label period of participant flow.
Subjects were seen at the Nasal Physiology Laboratory at the University of Chicago.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Propionate Only | Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily) |
| FG001 | Fluticasone Propionate+Montelukast | Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily) Montelukast - 10 mg po daily |
| FG002 | Fluticasone Propionate+Placebo | Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily) Placebo - 10 mg po daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open-Label Phase (2 Weeks) |
|
| ||||||||||||||||||
| Double-Blind, Randomized Phase (2 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Propionate + Montelukast | Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Montelukast - 10 mg po daily for 2 weeks |
| BG001 | Fluticasone Propionate + Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period | Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. | Posted | Median | Full Range | units on a scale | Baseline and 2 weeks |
|
During the two weeks of randomized treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluticasone Propionate + Montelukast | Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Montelukast - 10 mg po daily for 2 weeks |
Not provided
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Early termination of study due to difficulty recruiting
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Naclerio | University of Chicago | (773) 702-0080 | rnacleri@surgery.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
|
| Fluticasone propionate | Drug |
|
|
| Baseline and 2 weeks |
| Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period | Patients recorded the severity of runny nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The runny nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6. The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. | Baseline and 2 weeks |
| Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period | Patients recorded the severity of stuffy nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The stuffy nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6. The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. | Baseline and 2 weeks |
| Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period | Patients recorded the severity of other symptoms, including itchy nose/eyes and post-nasal drip, twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The other symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6. The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. | Baseline and 2 weeks |
| 14616102 | Background | van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x. |
| 15462688 | Background | Philip G, Nayak AS, Berger WE, Leynadier F, Vrijens F, Dass SB, Reiss TF. The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Curr Med Res Opin. 2004 Oct;20(10):1549-58. doi: 10.1185/030079904x3348. |
| 14987306 | Background | Di Lorenzo G, Pacor ML, Pellitteri ME, Morici G, Di Gregoli A, Lo Bianco C, Ditta V, Martinelli N, Candore G, Mansueto P, Rini GB, Corrocher R, Caruso C. Randomized placebo-controlled trial comparing fluticasone aqueous nasal spray in mono-therapy, fluticasone plus cetirizine, fluticasone plus montelukast and cetirizine plus montelukast for seasonal allergic rhinitis. Clin Exp Allergy. 2004 Feb;34(2):259-67. doi: 10.1111/j.1365-2222.2004.01877.x. |
| 15061398 | Background | Ciprandi G, Tosca MA, Milanese M, Schenone G, Ricca V. Antihistamines added to an antileukotriene in treating seasonal allergic rhinitis: histamine and leukotriene antagonism. Eur Ann Allergy Clin Immunol. 2004 Feb;36(2):67-70, 72. |
| 15049402 | Background | Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73. doi: 10.1016/S1081-1206(10)61576-1. |
| 14756468 | Background | Moinuddin R, deTineo M, Maleckar B, Naclerio RM, Baroody FM. Comparison of the combinations of fexofenadine-pseudoephedrine and loratadine-montelukast in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2004 Jan;92(1):73-9. doi: 10.1016/S1081-1206(10)61713-9. |
| 12801319 | Background | Topuz B, Ogmen GG. Montelukast as an adjuvant to mainstay therapies in patients with seasonal allergic rhinitis. Clin Exp Allergy. 2003 Jun;33(6):823-6. doi: 10.1046/j.1365-2222.2003.01690.x. |
| 12775135 | Background | Ratner PH, Howland WC 3rd, Arastu R, Philpot EE, Klein KC, Baidoo CA, Faris MA, Rickard KA. Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast. Ann Allergy Asthma Immunol. 2003 May;90(5):536-42. doi: 10.1016/S1081-1206(10)61847-9. |
| 12759270 | Background | Saengpanich S, deTineo M, Naclerio RM, Baroody FM. Fluticasone nasal spray and the combination of loratadine and montelukast in seasonal allergic rhinitis. Arch Otolaryngol Head Neck Surg. 2003 May;129(5):557-62. doi: 10.1001/archotol.129.5.557. |
| 12740532 | Background | Baena-Cagnani CE, Berger WE, DuBuske LM, Gurne SE, Stryszak P, Lorber R, Danzig M. Comparative effects of desloratadine versus montelukast on asthma symptoms and use of beta 2-agonists in patients with seasonal allergic rhinitis and asthma. Int Arch Allergy Immunol. 2003 Apr;130(4):307-13. doi: 10.1159/000070218. |
| 12602669 | Background | van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22. doi: 10.1016/S1081-1206(10)62144-8. |
| 12100048 | Background | Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice MP, Reiss TF; Montelukast Spring Rhinitis Study Group. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002 Jul;32(7):1020-8. doi: 10.1046/j.1365-2222.2002.01422.x. |
| 12086367 | Background | Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600. doi: 10.1016/S1081-1206(10)61891-1. |
| 12063523 | Background | Pullerits T, Praks L, Ristioja V, Lotvall J. Comparison of a nasal glucocorticoid, antileukotriene, and a combination of antileukotriene and antihistamine in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 2002 Jun;109(6):949-55. doi: 10.1067/mai.2002.124467. |
| 11686428 | Background | Wilson AM, Sims EJ, Orr LC, Coutie WJ, White PS, Gardiner Q, Lipworth BJ. Effects of topical corticosteroid and combined mediator blockade on domiciliary and laboratory measurements of nasal function in seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2001 Oct;87(4):344-9. doi: 10.1016/S1081-1206(10)62250-8. |
| 11359431 | Background | Wilson AM, Dempsey OJ, Sims EJ, Lipworth BJ. A comparison of topical budesonide and oral montelukast in seasonal allergic rhinitis and asthma. Clin Exp Allergy. 2001 Apr;31(4):616-24. doi: 10.1046/j.1365-2222.2001.01088.x. |
| 11167952 | Background | Wilson AM, Orr LC, Sims EJ, Lipworth BJ. Effects of monotherapy with intra-nasal corticosteroid or combined oral histamine and leukotriene receptor antagonists in seasonal allergic rhinitis. Clin Exp Allergy. 2001 Jan;31(1):61-8. |
| 11029334 | Background | Wilson AM, Orr LC, Sims EJ, Dempsey OJ, Lipworth BJ. Antiasthmatic effects of mediator blockade versus topical corticosteroids in allergic rhinitis and asthma. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1297-301. doi: 10.1164/ajrccm.162.4.9912046. |
| 20674827 | Derived | Esteitie R, deTineo M, Naclerio RM, Baroody FM. Effect of the addition of montelukast to fluticasone propionate for the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2010 Aug;105(2):155-61. doi: 10.1016/j.anai.2010.05.017. Epub 2010 Jun 19. |
| NOT COMPLETED |
|
Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Placebo - 10 mg po daily for 2 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Fluticasone Propionate + Montelukast |
Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Montelukast - 10 mg po daily for 2 weeks |
| OG001 | Fluticasone Propionate + Placebo | Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Placebo - 10 mg po daily for 2 weeks |
|
|
|
| Secondary | Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period | Patients recorded the severity of sneezing twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The sneezing symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6. The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. | Posted | Median | Full Range | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period | Patients recorded the severity of runny nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The runny nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6. The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. | Posted | Median | Full Range | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period | Patients recorded the severity of stuffy nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The stuffy nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6. The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. | Posted | Median | Full Range | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period | Patients recorded the severity of other symptoms, including itchy nose/eyes and post-nasal drip, twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The other symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6. The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. | Posted | Median | Full Range | units on a scale | Baseline and 2 weeks |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Fluticasone Propionate + Placebo | Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Placebo - 10 mg po daily for 2 weeks | 0 | 26 | 0 | 26 |
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |