The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)
NCT ID: NCT00911547
Last Updated: 2022-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
642 participants
INTERVENTIONAL
1995-03-31
1996-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Montelukast + Beclomethasone
montelukast sodium
10 mg tablet taken once daily at bedtime for 16 weeks
beclomethasone
200 ug inhaled, taken twice daily for 16 weeks
2
Montelukast + Placebo inhaler
montelukast sodium
10 mg tablet taken once daily at bedtime for 16 weeks
Placebo inhaler
placebo inhaler taken twice daily for 16 weeks
3
Placebo tablet + Beclomethasone
beclomethasone
200 ug inhaled, taken twice daily for 16 weeks
placebo tablet
placebo tablet taken once daily at bedtime for 16 weeks
4
Placebo tablet + Placebo inhaler
Placebo inhaler
placebo inhaler taken twice daily for 16 weeks
placebo tablet
placebo tablet taken once daily at bedtime for 16 weeks
Interventions
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montelukast sodium
10 mg tablet taken once daily at bedtime for 16 weeks
beclomethasone
200 ug inhaled, taken twice daily for 16 weeks
Placebo inhaler
placebo inhaler taken twice daily for 16 weeks
placebo tablet
placebo tablet taken once daily at bedtime for 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient was a nonsmoker
* Patient was in good general health (except for asthma)
Exclusion Criteria
* Patient was female who was less than 8 weeks postpartum or breast feeding
* Patient planned to move or vacation away during the study
* Patient had major surgery within 4 weeks the past 4 weeks
* Patient has donated blood or participated in a clinical trial within the past 4 weeks
* Patient was a regular user or recent abuser of alcohol or illicit drugs
* Patient was 40% over or under normal weight for height
15 Years
85 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Laviolette M, Malmstrom K, Lu S, Chervinsky P, Pujet JC, Peszek I, Zhang J, Reiss TF. Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/Beclomethasone Additivity Group. Am J Respir Crit Care Med. 1999 Dec;160(6):1862-8. doi: 10.1164/ajrccm.160.6.9803042.
Other Identifiers
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2009_596
Identifier Type: -
Identifier Source: secondary_id
0476-029
Identifier Type: -
Identifier Source: org_study_id
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