Singulair(R) In Asthma And Allergic Rhinitis (0476-383)

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast sodium

• Registration Number: NCT00545844
• Lead Sponsor: Organon and Co

Brief Summary

Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-01
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2008-01-01
• Study Completion: 2008-01-01
• Results First Submitted: 2008-12-19
• Results First Submitted QC: 2009-07-07
• Results First Posted: 2009-08-19
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

• Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage
• Peak expiratory flow is > or = 80% of predicted value on the day of visit 1
• Uncontrolled as per Canadian asthma consensus guidelines

Exclusion Criteria

• Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms
• Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	montelukast sodium	montelukast sodium

Primary Outcome Measures

Name	Time	Method
Asthma Control	8 weeks (from Week 0 to Week 8)	Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered "yes" to at least 2 of the 8 asthma control parameters.

Secondary Outcome Measures

Name	Time	Method
The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score	8 weeks (from Week 0 to Week 8)	Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score
Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)	8 weeks (from Week 0 to Week 8)	The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale.