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

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545844

0476-383

MK0476-383

2007_024

Details and patient eligibility

About

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

Enrollment: 313 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

313 participants in 1 patient group

1

Experimental group

Description:

montelukast sodium

Treatment:

Drug: montelukast sodium