Singulair(R) In Asthma And Allergic Rhinitis
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00545844
First received: October 16, 2007
Last updated: April 20, 2010
Last verified: April 2010
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Purpose
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: montelukast sodium |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Asthma Control [ Time Frame: 8 weeks (from Week 0 to Week 8) ] [ Designated as safety issue: No ]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:
- The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score [ Time Frame: 8 weeks (from Week 0 to Week 8) ] [ Designated as safety issue: No ]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) [ Time Frame: 8 weeks (from Week 0 to Week 8) ] [ Designated as safety issue: No ]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.
| Enrollment: | 313 |
| Study Start Date: | April 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
montelukast sodium
|
Drug: montelukast sodium
montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Other Name: Singulair
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00545844 History of Changes |
| Other Study ID Numbers: | 2007_024, MK0476-383 |
| Study First Received: | October 16, 2007 |
| Results First Received: | December 19, 2008 |
| Last Updated: | April 20, 2010 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Asthma Rhinitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Nose Diseases |
Respiratory Tract Infections Otorhinolaryngologic Diseases Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 17, 2012
