An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis

Organon and Co0 sites313 target enrollmentApril 1, 2007

ConditionsAsthma

Interventionsmontelukast sodium

Drugsmontelukast sodium

Overview

Phase: Phase 4
Intervention: montelukast sodium
Conditions: Asthma
Sponsor: Organon and Co
Enrollment: 313
Primary Endpoint: Asthma Control
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 1, 2007

End Date

January 1, 2008

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

1

montelukast sodium

Intervention: montelukast sodium

Outcomes

Primary Outcomes

Asthma Control

Time Frame: 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 Outcomes

The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score(8 weeks (from Week 0 to Week 8))
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))