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

NCT00545844 | Completed Phase 4 Results

• 3 other identifiers: 0476-383MK0476-3832007_024
• Study Type: interventional
• Target: 313
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma Control

  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.

  8 weeks (from Week 0 to Week 8)

Secondary Outcomes (2)

• 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)

Other Outcomes (3)

• Patient Global Satisfaction

  8 weeks (from Week 0 to Week 8)

• Physician Global Satisfaction

  8 weeks (from Week 0 to Week 8)

• Patient Global Allergic Rhinitis Symptoms Assessment

  8 weeks (from Week 0 to Week 8)

Study Arms (1)

1

EXPERIMENTAL

montelukast sodium

Drug: montelukast sodium

Interventions

montelukast sodium DRUG

montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment

Also known as: Singulair

1

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Keith PK, Koch C, Djandji M, Bouchard J, Psaradellis E, Sampalis JS, Schellenberg RR, McIvor RA. Montelukast as add-on therapy with inhaled corticosteroids alone or inhaled corticosteroids and long-acting beta-2-agonists in the management of patients diagnosed with asthma and concurrent allergic rhinitis (the RADAR trial). Can Respir J. 2009 May-Jun;16 Suppl A(Suppl A):17A-31A. doi: 10.1155/2009/145071.

  PMID: 19557208 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 23, 2024
• Results First Posted: August 19, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share