NCT00666679

Brief Summary

This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 3, 2010

Completed
Last Updated

May 10, 2024

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

April 23, 2008

Results QC Date

January 7, 2010

Last Update Submit

May 7, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)

    To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.

    Baseline and 2 weeks

Secondary Outcomes (2)

  • Change From Baseline in Daytime Asthma Symptom Score

    Baseline and 2 weeks

  • Change From Baseline in Nighttime Asthma Symptom Score

    Baseline and 2 weeks

Other Outcomes (4)

  • Change From Baseline in Total Daily β-agonist Use

    Baseline and 2 weeks

  • Percentage of Days With Asthma Control

    2 weeks

  • Percentage of Days With Asthma Exacerbations

    2 Weeks

  • +1 more other outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

mometasone

Drug: Comparator: mometasone

2

PLACEBO COMPARATOR

montelukast followed by placebo; or placebo followed by montelukast.

Drug: Comparator: montelukastDrug: Comparator: placebo (unspecified)

Interventions

Comparator: mometasoneDRUG

mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)

1
Comparator: montelukastDRUG

montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)

2
Comparator: placebo (unspecified)DRUG

Placebo (Placebo once-daily, for approximately 2 weeks)

2

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler
  • Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator

You may not qualify if:

  • Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components
  • Has required an oral corticosteroid rescue for worsening asthma during the screening period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Philip G, Villaran C, Shah SR, Vandormael K, Smugar SS, Reiss TF. The efficacy and tolerability of inhaled montelukast plus inhaled mometasone compared with mometasone alone in patients with chronic asthma. J Asthma. 2011 Jun;48(5):495-502. doi: 10.3109/02770903.2011.573042. Epub 2011 May 5.

    PMID: 21545249RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

May 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

May 10, 2024

Results First Posted

February 3, 2010

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share