Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study - Full Text View

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:

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 [ 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963599

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:	NCT00963599 History of Changes
Other Study ID Numbers:	2009_645, MK0476A-117
Study First Received:	August 19, 2009
Results First Received:	August 31, 2009
Last Updated:	June 21, 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