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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545844
• Other study ID #: 0476-383
• Secondary ID: MK0476-3832007_0
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2007
• Est. completion date: January 1, 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: January 1, 2008
• Est. primary completion date: January 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Global Satisfaction	At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.	8 weeks (from Week 0 to Week 8)
Other	Physician Global Satisfaction	At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication.	8 weeks (from Week 0 to Week 8)
Other	Patient Global Allergic Rhinitis Symptoms Assessment	At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.	8 weeks (from Week 0 to Week 8)
Primary	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	The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score	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	8 weeks (from Week 0 to Week 8)
Secondary	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)	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.	8 weeks (from Week 0 to Week 8)