An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00132730
First received: August 3, 2005
Last updated: January 26, 2010
Last verified: January 2010
  Purpose

This is a study to evaluate the effectiveness and tolerability of a once-daily oral medication for the treatment of COPD (chronic obstructive pulmonary disease) to determine whether the study drug leads to an improvement in pulmonary (lung) function, as well as symptoms, and quality of life.


Condition Intervention Phase
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Drug: MK0873 2.5 mg
Drug: Comparator: MK0873 1.25 mg
Drug: Comparator: MK0873 0.75 mg
Drug: Comparator: Placebo Comparator
Drug: Comparator: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0873 in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Pre-dose (trough) forced expiratory volume in 1 second measured over the last 4 weeks of a 12 week treatment period [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall daytime symptoms score [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Total daily beta-agonist use [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Saint George's Respiratory Questionnaire [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Transitional Dyspnea Rating [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Shortness of Breath Questionnaire [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Chronic Obstructive Pulmonary Disease Exacerbations [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Predose forced vital capacity [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 604
Study Start Date: June 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Period I: Placebo; Period II: MK0873 2.5 mg
Drug: MK0873 2.5 mg
Period II: MK0873 2.5 mg once daily over 12 weeks
Drug: Comparator: Placebo
Period I: Placebo once daily for one day (run-in)
Experimental: Group 2
Period I: Placebo; Period II: MK0873 1.25 mg
Drug: Comparator: MK0873 1.25 mg
Period II: MK0873 1.25 mg once daily over 12 weeks
Drug: Comparator: Placebo
Period I: Placebo once daily for one day (run-in)
Experimental: Group 3
Period I: Placebo; Period II: MK0873 0.75 mg
Drug: Comparator: MK0873 0.75 mg
Period II: MK0873 0.75 mg once daily over 12 weeks
Drug: Comparator: Placebo
Period I: Placebo once daily for one day (run-in)
Placebo Comparator: Group 4
Period I: Placebo; Period II: Placebo
Drug: Comparator: Placebo Comparator
Period II: Placebo to MK0873 once daily over 12 weeks.
Drug: Comparator: Placebo
Period I: Placebo once daily for one day (run-in)

Detailed Description:

Following the 12-week active treatment period, patients were invited to continue in an optional 12-week double-blind extension (Period III; MK0873-005-10). Patients who received MK-0873 in the base study continued on 2.5 mg of MK0873 daily while patients in the placebo arm of the base study continued on placebo.

Following Period III, patients were invited to enroll in an optional 28-week, open label extension (Period IV, MK0873-005-20). Patients who had been taking MK-0873 were allocated to 2.5 mg MK0873 + usual care, while patients who had been taking placebo were allocated to usual care alone.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 40 to 75 years old, with a history consistent with COPD (chronic obstructive pulmonary disease)
  • Lung function tests that meet the requirements of the study

Exclusion Criteria:

  • Severe and unstable medical conditions other than COPD (chronic obstructive pulmonary disease)
  • Use of continuous oxygen therapy
  • Cardiac (heart) arrhythmias
  • Other lung disease
  • History of colitis (inflammation of the colon)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132730

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00132730     History of Changes
Other Study ID Numbers: 2005_015, MK0873-005
Study First Received: August 3, 2005
Last Updated: January 26, 2010
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 20, 2014