Clinical trial NCT00132730: An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease) (MK-0873-005)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK-0873 in Patients With COPD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 604
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the effectiveness and tolerability of a once-daily oral medication (MK-0873) 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.

Detailed description: Following a three-week run-in period (Period I) during which participants received placebo, participants entered into a 12-week double-blind treatment period (Period II) during which they received daily doses of either one of three doses of MK-0873 or placebo. Period I and Period II made up the Base Study. Following the 12-week treatment period in the Base Study, participants were invited to continue in an optional 12-week double-blind extension study (Period III, EXT1). Participants who received any dose of MK-0873 in the Base Study continued on MK-0873 2.5 mg daily in Period III while participants in the placebo arm of the Base Study continued on placebo daily. Following EXT1, participants were invited to continue in an optional open-label second extension study (EXT2) which was to last 80 weeks (Period IV: 28 weeks, Period V: 52 weeks). In EXT2, participants who had been taking MK-0873 2.5 mg in the Base Study were allocated to MK-0873 2.5 mg plus usual care, while participants who had been taking the other two doses of MK-0873 or placebo in the Base Study were allocated to either MK-0873 2.5 mg plus usual care or to usual care alone.

Eligibility 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)

Primary outcomes:
measure: Change From Baseline in Pre-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Pre-dose at Baseline and Treatment Weeks 8, 10 and 12
Secondary outcomes:
measure: Change From Baseline in Overall Daytime Symptoms Score
timeFrame: Baseline and Treatment Weeks 8, 10 and 12
measure: Change From Baseline in Total Daily Beta-agonist Use
timeFrame: Baseline and Treatment Weeks 8, 10 and 12
measure: Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Response
timeFrame: Baseline and Treatment Weeks 8 and 12
measure: Transition Dyspnea Index (TDI) Focal Score
timeFrame: Baseline and Treatment Week 12
measure: Change From Baseline in Shortness of Breath Questionnaire (SOBQ) Response
timeFrame: Baseline and Treatment Weeks 8 and 12
measure: Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
timeFrame: Baseline through Treatment Week 12
measure: Change From Baseline in Predose (Trough) Forced Vital Capacity (FVC)
timeFrame: Predose at Baseline and Treatment Weeks 8, 10 and 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: