The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092118
First received: September 21, 2004
Last updated: June 29, 2010
Last verified: June 2010
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Purpose
The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis, Allergic, Perennial |
Drug: Montelukast Drug: Comparator: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis [ Time Frame: 6 week treatment period (from baseline though the end of week 6) ] [ Designated as safety issue: No ]Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)].
Secondary Outcome Measures:
- Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period [ Time Frame: At the end of the 6 week treatment period ] [ Designated as safety issue: No ]An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.
- Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.
| Enrollment: | 1992 |
| Study Start Date: | October 2003 |
| Study Completion Date: | May 2004 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Montelukast
|
Drug: Montelukast
one 10 mg tablet, taken once daily at bed time for 6 weeks
|
|
Placebo Comparator: 2
Placebo
|
Drug: Comparator: Placebo
one placebo tablet, taken once daily at bed time for 6 weeks
|
Eligibility| Ages Eligible for Study: | 15 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing
Exclusion Criteria:
- Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00092118 History of Changes |
| Other Study ID Numbers: | 2004_018, MK0476-265 |
| Study First Received: | September 21, 2004 |
| Results First Received: | September 10, 2009 |
| Last Updated: | June 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013