Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00963469
First received: August 19, 2009
Last updated: May 12, 2010
Last verified: May 2010
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Purpose
This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: montelukast sodium Drug: Comparator: loratadine Drug: Comparator: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis Over a 4-Week Treatment Period-Fall 2001 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ] [ Designated as safety issue: No ]Mean change from baseline in Daytime Nasal Symptoms Score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Secondary Outcome Measures:
- Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ] [ Designated as safety issue: No ]Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
- Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ] [ Designated as safety issue: No ]Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].
- Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ] [ Designated as safety issue: No ]Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
- Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment [ Time Frame: After first 2 weeks of treatment ] [ Designated as safety issue: No ]An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
- Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment [ Time Frame: After first 2 weeks of treatment ] [ Designated as safety issue: No ]An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
- Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period [ Time Frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) ] [ Designated as safety issue: No ]Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.
| Enrollment: | 1079 |
| Study Start Date: | August 2001 |
| Study Completion Date: | March 2002 |
| Primary Completion Date: | November 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
montelukast
|
Drug: montelukast sodium
montelukast 10 mg tablet orally once daily in the morning for 4 weeks
|
|
Active Comparator: 2
loratadine
|
Drug: Comparator: loratadine
loratadine 10 mg tablet orally once daily in the morning for 4 weeks
|
|
Placebo Comparator: 3
placebo
|
Drug: Comparator: placebo
placebo tablet orally once daily in the morning for 4 weeks
|
Eligibility| Ages Eligible for Study: | 15 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has a history of seasonal allergic rhinitis that worsens during the study season
- Patient is a nonsmoker
- Patient is in good health physical and mental health
Exclusion Criteria:
- Patient is hospitalized
- Patient is a woman who is < 8 weeks postpartum or is breastfeeding
- Patient plans to move or vacation away during the study
- Patient has had any major surgery with in past 4 weeks
- Patient is a current or past abuser of alcohol or illicit drugs
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00963469 History of Changes |
| Other Study ID Numbers: | 2009_647, MK0476-240 |
| Study First Received: | August 19, 2009 |
| Results First Received: | September 16, 2009 |
| Last Updated: | May 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Loratadine Montelukast Antipruritics Dermatologic Agents Therapeutic Uses |
Pharmacologic Actions Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 23, 2013