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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Loratadine
Montelukast
Anti-Allergic Agents
Anti-Asthmatic Agents
Antipruritics
Dermatologic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014