An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease) (MK-0873-005)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Lung Diseases; Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Usual Care; Drug: MK-0873 2.5 mg; Drug: MK-0873 0.75 mg; Drug: MK-0873 1.25 mg; Drug: Placebo to MK-0873

Study type: Interventional

Funder types: Industry

Identifiers

NCT00132730

2005_015 (Other Identifier)

0873-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 604 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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604 participants in 6 patient groups, including a placebo group

MK-0873 2.5 mg

Experimental group

Description:

Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)

Treatment:

Drug: Placebo to MK-0873

Drug: MK-0873 2.5 mg

MK-0873 1.25 mg

Experimental group

Description:

Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)

Treatment:

Drug: Placebo to MK-0873

Drug: MK-0873 1.25 mg

MK-0873 0.75 mg

Experimental group

Description:

Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)

Treatment:

Drug: MK-0873 0.75 mg

Drug: Placebo to MK-0873

Placebo

Placebo Comparator group

Description:

Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)

Treatment:

Drug: Placebo to MK-0873

MK-0873 2.5 mg + Usual Care

Experimental group

Description:

Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks during Periods IV and V (EXT2)

Treatment:

Drug: MK-0873 2.5 mg

Drug: Usual Care

Usual Care

Active Comparator group

Description:

Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks during Periods IV and V (EXT2)

Treatment:

Drug: Usual Care