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

• ClinicalTrials.gov Identifier: NCT00911547
• Recruitment Status: Completed
• First Posted: June 2, 2009
• Results First Posted: June 9, 2010
• Last Update Posted: February 3, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: montelukast sodium; Drug: beclomethasone; Drug: Placebo inhaler; Drug: placebo tablet	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 642 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: March 1995
• Actual Primary Completion Date: April 1996
• Actual Study Completion Date: May 1996

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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
2. 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 ]

   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 :

1. 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 ]
   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.
2. 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 ]
   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.
3. 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 ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 85 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Organon and Co

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

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.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00911547
• Other Study ID Numbers: 0476-029; 2009_596
• First Posted: June 2, 2009
• Results First Posted: June 9, 2010
• Last Update Posted: February 3, 2022
• Last Verified: February 2022

Keywords provided by Organon and Co:

chronic asthma

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Beclomethasone; Montelukast; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones