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Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00979901
First Posted: September 18, 2009
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.

Condition Intervention Phase
Seasonal Allergic Rhinitis Drug: Comparator: montelukast Drug: Comparator: loratadine Drug: Comparator: placebo Drug: Comparator: montelukast/loratadine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring 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 2 Weeks [ Time Frame: Baseline and Week 2 ]

    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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal

    Symptoms Score. Scores were measured as 0 (best) to 3 (worst).



Secondary Outcome Measures:
  • Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks [ Time Frame: Baseline and Week 2 ]

    Mean change from baseline in Nighttime Symptoms Score.

    Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst).


  • Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks [ Time Frame: Baseline and Week 2 ]

    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. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst).


  • Patient's Global Evaluation of Allergic Rhinitis at Week 2 [ Time Frame: Week 2 ]

    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. Scores were measured as 0 (best) to 6 (worst).


  • Physician's Global Evaluation of Allergic Rhinitis at Week 2 [ Time Frame: Week 2 ]
    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. Scores were measured as 0 (best) to 6 (worst).

  • Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 [ Time Frame: Week 2 ]
    Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).


Enrollment: 1577
Study Start Date: March 2000
Study Completion Date: May 2000
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
montelukast
Drug: Comparator: montelukast
10 mg montelukast tablet given once daily at bedtime for 2 weeks
Experimental: 2
loratadine
Drug: Comparator: loratadine
10 mg loratadine tablet given once daily at bedtime for 2 weeks
Placebo Comparator: 3
placebo
Drug: Comparator: placebo
placebo tablet given once daily at bedtime for 2 weeks
Experimental: 4
montelukast/loratadine
Drug: Comparator: montelukast/loratadine
montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 and has been a nonsmoker for at least 1 year
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979901


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: NCT00979901     History of Changes
Other Study ID Numbers: 0476A-162
MK0476A-162
2009_664
First Submitted: September 17, 2009
First Posted: September 18, 2009
Results First Submitted: September 23, 2009
Results First Posted: June 8, 2010
Last Update Posted: May 20, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
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
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents