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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911547
• Other study ID #: 0476-029
• Secondary ID: 2009_596
• Status: Completed
• Phase: Phase 3
• Start date: March 1995
• Est. completion date: May 1996

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: May 1996
• Est. primary completion date: April 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma	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	Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups
Primary	Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma	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.	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Secondary	Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use	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.	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Secondary	Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma	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.	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Secondary	Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only	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.	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups