Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00963469
First received: August 19, 2009
Last updated: May 7, 2014
Last verified: May 2014
  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 Sharp & Dohme Corp.:

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
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: NCT00963469

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00963469     History of Changes
Other Study ID Numbers: 0476-240, MK0476-240, 2009_647
Study First Received: August 19, 2009
Results First Received: September 16, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014