NCT00284856

Brief Summary

This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,640

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started May 2006

Longer than P75 for phase_3 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

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 3, 2011

Completed
Last Updated

May 10, 2024

Status Verified

January 1, 2022

Enrollment Period

3.9 years

First QC Date

January 31, 2006

Results QC Date

April 6, 2011

Last Update Submit

May 7, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Percentage of Asthma-control Days Over the 6-month Treatment Period

    An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of \> than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.

    6 months

Secondary Outcomes (2)

  • Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period

    Baseline and 6 months

  • Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period

    Baseline and 6 months

Study Arms (3)

1

EXPERIMENTAL

Arm 1: Montelukast

Drug: montelukast sodiumDrug: Comparator: Placebo

2

ACTIVE COMPARATOR

Arm 2: Fluticasone

Drug: Comparator: fluticasoneDrug: Comparator: Placebo

3

PLACEBO COMPARATOR

Arm 3: Placebo

Drug: Comparator: Placebo

Interventions

montelukast sodiumDRUG

montelukast 10 mg tablet once daily, 6 month treatment period

1
Comparator: PlaceboDRUG

fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period

13
Comparator: fluticasoneDRUG

fluticasone propionate 250 mcg twice daily, 6 month treatment period

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day

You may not qualify if:

  • Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Price D, Popov TA, Bjermer L, Lu S, Petrovic R, Vandormael K, Mehta A, Strus JD, Polos PG, Philip G. Effect of montelukast for treatment of asthma in cigarette smokers. J Allergy Clin Immunol. 2013 Mar;131(3):763-71. doi: 10.1016/j.jaci.2012.12.673. Epub 2013 Feb 4.

    PMID: 23380218RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukast

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Start

May 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 10, 2024

Results First Posted

May 3, 2011

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share