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Completed

NCT Number: NCT00911547

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

10 mg tablet taken once daily at bedtime for 16 weeks

Other names: MK0476

Beclomethasone

Drug

200 ug inhaled, taken twice daily for 16 weeks

Placebo Inhaler

Drug

placebo inhaler taken twice daily for 16 weeks

Placebo Tablet

Drug

placebo tablet taken once daily at bedtime for 16 weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
1995
Primary completion
1996
Study completion
1996
First posted
Jun 2, 2009
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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