Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study - Full Text View

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 Endpoint Classification: Safety/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 Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring Study

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Loratadine Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks [ 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. 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 ] [ 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, 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 ] [ 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. 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 ] [ 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. Scores were measured as 0 (best) to 6 (worst).
Physician's Global Evaluation of Allergic Rhinitis at Week 2 [ 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. 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 ] [ Designated as safety issue: No ]
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:	August 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

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979901

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00979901 History of Changes
Other Study ID Numbers:	2009_664, MK0476A-162
Study First Received:	September 17, 2009
Results First Received:	September 23, 2009
Last Updated:	June 7, 2010
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 May 21, 2013