The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
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| ClinicalTrials.gov Identifier: NCT00119015 |
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Recruitment Status :
Terminated
(Difficulty in recruitment)
First Posted : July 12, 2005
Results First Posted : May 22, 2013
Last Update Posted : February 28, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rhinitis, Allergic, Perennial | Drug: Placebo Drug: Montelukast Drug: Fluticasone propionate | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis |
| Study Start Date : | July 2005 |
| Actual Primary Completion Date : | June 2008 |
| Actual Study Completion Date : | January 2009 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 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 |
Drug: Placebo Drug: Fluticasone propionate Other Name: flonase |
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Active Comparator: 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 |
Drug: Montelukast
Other Name: singulair Drug: Fluticasone propionate Other Name: flonase |
- Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period [ Time Frame: Baseline and 2 weeks ]
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.
- Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period [ Time Frame: Baseline and 2 weeks ]
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.
- Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period [ Time Frame: Baseline and 2 weeks ]
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.
- Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period [ Time Frame: Baseline and 2 weeks ]
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.
- Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period [ Time Frame: Baseline and 2 weeks ]
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.
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- A clinical history of perennial allergic rhinitis and a positive skin prick test to dust mite, cockroach, mold, or cat or dog antigens.
- Willingness of the subject to participate in and complete the study, and the ability to understand the purpose of the trial.
Exclusion Criteria:
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Women of childbearing potential who are pregnant, trying to become pregnant or nursing a child.
- Subjects treated with systemic steroids during the previous 30 days.
- Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 15 days.
- Subjects treated with oral antihistamines/decongestants during the previous seven days.
- Subjects treated with topical (intranasal or intraocular) antihistamines/decongestants during the previous 3 days.
- Subjects treated with immunotherapy who are escalating their dose.
- Subjects on chronic anti-asthma medications.
- Subjects with polyps in the nose or a significantly displaced septum.
- Subjects who have incurred an upper respiratory tract infection within 14 days of the start of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119015
| United States, Illinois | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: | Robert M Naclerio, MD | University of Chicago |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00119015 |
| Other Study ID Numbers: |
13875B SING-US-60-04 |
| First Posted: | July 12, 2005 Key Record Dates |
| Results First Posted: | May 22, 2013 |
| Last Update Posted: | February 28, 2014 |
| Last Verified: | January 2014 |
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perennial allergic rhinitis |
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Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Xhance Montelukast |
Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |