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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972738
• Other study ID #: 0476-235
• Secondary ID: MK0476-2352009_6
• Status: Completed
• Phase: Phase 3
• Start date: April 2001
• Est. completion date: July 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: July 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• montelukast sodium
Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.
• Comparator: loratadine
Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.
• Comparator: Placebo
placebo tablet orally once daily at bedtime for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period	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.	Baseline and over the 2-week treatment period
Secondary	Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period	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.	Baseline and over the 2-week treatment period
Secondary	Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period	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.	Baseline and over the 2-week treatment period
Secondary	Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period	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.	End of the 2-week treatment period
Secondary	Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period	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.	End of the 2-week treatment period
Secondary	Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period	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.	Baseline and at the end of 2-week treatment period