Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00972738
First received: September 4, 2009
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.


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 Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 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 Over the 2-week Treatment Period [ Time Frame: Baseline and over the 2-week treatment period ] [ Designated as safety issue: No ]
    Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 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 Over the 2-week Treatment Period [ Time Frame: Baseline and over the 2-week treatment period ] [ Designated as safety issue: No ]
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.

  • Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period [ Time Frame: Baseline and over the 2-week treatment period ] [ Designated as safety issue: No ]
    Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms 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.

  • Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period [ Time Frame: End of the 2-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 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.

  • Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period [ Time Frame: End of the 2-week treatment period ] [ Designated as safety issue: No ]
    An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.

  • Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period [ Time Frame: Baseline and at the end of 2-week treatment period ] [ Designated as safety issue: No ]
    Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.


Enrollment: 1214
Study Start Date: April 2001
Study Completion Date: September 2001
Primary Completion Date: July 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 at bedtime for 2 weeks.
Active Comparator: 2
loratadine
Drug: Comparator: loratadine
Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.
Placebo Comparator: 3
placebo
Drug: Comparator: Placebo
placebo tablet orally once daily at bedtime 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 season 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 <8 weeks postpartum or is breast-feeding
  • Patient has had major surgery in the past 4 weeks
  • Patient intends to move or vacation away during the study
  • 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: NCT00972738

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: NCT00972738     History of Changes
Other Study ID Numbers: 0476-235, MK0476-235, 2009_658
Study First Received: September 4, 2009
Results First Received: September 15, 2009
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
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
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014