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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963469
• Other study ID #: 0476-240
• Secondary ID: MK0476-2402009_6
• Status: Completed
• Phase: Phase 3
• Start date: August 2001
• Est. completion date: November 2001

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1079
• Est. completion date: November 2001
• Est. primary completion date: November 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• montelukast sodium
montelukast 10 mg tablet orally once daily in the morning for 4 weeks
• Comparator: loratadine
loratadine 10 mg tablet orally once daily in the morning for 4 weeks
• Comparator: placebo
placebo tablet orally once daily in the morning for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. Erratum in: Allergy. 2004 Mar;59(3):357. Allergy. 2009 Nov;64(11):1697. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period	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.	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Secondary	Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period	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.	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Secondary	Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period	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)].	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Secondary	Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period	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.	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Secondary	Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment	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.	After first 2 weeks of treatment
Secondary	Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment	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.	After first 2 weeks of treatment
Secondary	Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period	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.	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)