Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00963599
First received: August 19, 2009
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Comparator: montelukast/loratadine
Drug: Comparator: montelukast
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 Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean Change From Baseline in Daytime Nasal Symptoms Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). 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 [ Time Frame: Baseline and 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 (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.

  • Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).

  • Mean Change From Baseline in Daytime Eye Symptoms Score [ Time Frame: Baseline and 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 (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.

  • Mean Change From Baseline in Daytime Nasal Congestion Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).

  • Mean Change From Baseline in Daytime Rhinorrhea Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).

  • Mean Change From Baseline in Daytime Nasal Itching Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).

  • Mean Change From Baseline in Daytime Sneezing Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).

  • Mean Change From Baseline in Nasal Congestion Upon Awakening [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).

  • Patient's Global Evaluation of Allergic Rhinitis [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).

  • Physician's Global Evaluation of Allergic Rhinitis [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).

  • Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score [ Time Frame: 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: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.


Enrollment: 907
Study Start Date: September 1999
Study Completion Date: November 1999
Primary Completion Date: November 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
montelukast/loratadine
Drug: Comparator: montelukast/loratadine
montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
Experimental: 2
loratadine
Drug: Comparator: loratadine
loratadine 10 mg tablet taken once daily at bed time for 2 weeks
Experimental: 3
montelukast
Drug: Comparator: montelukast
montelukast 10 mg tablet taken once daily at bed time for 2 weeks
Placebo Comparator: 4
placebo
Drug: Comparator: placebo
placebo tablet taken once daily at bed time for 2 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 documented history of seasonal allergic rhinitis symptoms that flare up during the study season
  • Patient is a nonsmoker
  • Patient is in good general health

Exclusion Criteria:

  • Patient is hospitalized
  • Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
  • Patient intends to move or vacation away during the study
  • Patient has had any major surgery within 4 weeks of study start
  • Patient is a current or past abuser of alcohol or illicit drugs
  • Patient has been treated in an emergency room for asthma in the past month
  • Patient had an upper respiratory infection with in 3 weeks prior to study start
  • Patient has any active pulmonary disorder other than asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963599

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00963599     History of Changes
Other Study ID Numbers: 0476A-117, MK0476A-117, 2009_645
Study First Received: August 19, 2009
Results First Received: August 31, 2009
Last Updated: February 27, 2014
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 April 17, 2014