The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00911547
First received: May 29, 2009
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.


Condition Intervention Phase
Asthma
Drug: montelukast sodium
Drug: beclomethasone
Drug: Placebo inhaler
Drug: placebo tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma [ Time Frame: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups ] [ Designated as safety issue: No ]
    Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups

  • Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma [ Time Frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups ] [ Designated as safety issue: No ]

    The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary.

    The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits.



Secondary Outcome Measures:
  • Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use [ Time Frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups ] [ Designated as safety issue: No ]
    Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.

  • Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma [ Time Frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups ] [ Designated as safety issue: No ]
    Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.

  • Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only [ Time Frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups ] [ Designated as safety issue: No ]

    Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, "Did you wake up with asthma symptoms?" (no, once, more than once, awake "all night"), were assigned numerical values (0, 1, 2, 3, respectively).

    The average score for the visit was determined by averaging the daily scores over all days between consecutive visits.



Enrollment: 642
Study Start Date: March 1995
Study Completion Date: May 1996
Primary Completion Date: April 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Montelukast + Beclomethasone
Drug: montelukast sodium
10 mg tablet taken once daily at bedtime for 16 weeks
Other Name: MK0476
Drug: beclomethasone
200 ug inhaled, taken twice daily for 16 weeks
Experimental: 2
Montelukast + Placebo inhaler
Drug: montelukast sodium
10 mg tablet taken once daily at bedtime for 16 weeks
Other Name: MK0476
Drug: Placebo inhaler
placebo inhaler taken twice daily for 16 weeks
Experimental: 3
Placebo tablet + Beclomethasone
Drug: beclomethasone
200 ug inhaled, taken twice daily for 16 weeks
Drug: placebo tablet
placebo tablet taken once daily at bedtime for 16 weeks
Placebo Comparator: 4
Placebo tablet + Placebo inhaler
Drug: Placebo inhaler
placebo inhaler taken twice daily for 16 weeks
Drug: placebo tablet
placebo tablet taken once daily at bedtime for 16 weeks

  Eligibility

Ages Eligible for Study:   15 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study
  • Patient was a nonsmoker
  • Patient was in good general health (except for asthma)

Exclusion Criteria:

  • Patient was hospitalized
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911547

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00911547     History of Changes
Other Study ID Numbers: 0476-029, 2009_596
Study First Received: May 29, 2009
Results First Received: July 24, 2009
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
chronic asthma

Additional relevant MeSH terms:
Montelukast
Beclomethasone
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on September 22, 2014