A Double-Blind Randomized, Parallel-Group, Multicenter Clinical Study to Compare the Efficacy and Tolerability of Tiotropium Bromide Alone vs. the Co-Administration of Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD

Merck Sharp & Dohme LLC0 sites255 target enrollmentSeptember 1, 2005

ConditionsPulmonary Disease, Chronic Obstructive

Drugsformoterol fumarate

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 255
Primary Endpoint: effects of tiotropium bromide alone vs.the effect of tiotropium bromide and formoterol fumarate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.

Registry

clinicaltrials.gov

Start Date

September 1, 2005

End Date

November 21, 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have a clinical history of COPD.
•Subjects must be current cigarette smokers or ex-smokers who stopped smoking at least 3 months prior to screening visit (V1). Subjects must have a smoking history of at least 10 pack-years (20 cigarettes per pack). Pack-years are calculated by multiplying the average packs of cigarettes smoked per day times the number of years.
•Subjects on stable inhaled corticosteroids are allowed to be enrolled and to remain on the treatment throughout the study.
•Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
•Subjects must agree to inform their usual treating physician of their participation in this study.
•Female subjects of childbearing potential must have a negative urine pregnancy test prior to the randomization of the study
•Nonpregnant women of childbearing potential must be using a medically acceptable, adequate form of birth control.

Exclusion Criteria

•Subjects have a current or past history of clinically relevant asthma.
•Subjects quit smoking less than 3 months prior to the Screening visit (V1).
•Subjects have required ventilator support for respiratory failure within the last year.
•Subjects have clinically significant lung disease other than COPD, e.g., bronchiectasis, sarcoidosis, pulmonary fibrosis, tuberculosis, etc.
•Subjects have undergone lobectomy, pneumonectomy or lung volume reduction surgery.
•Subjects have had lung cancer diagnosed or treated within the last five years.
•Subjects require nasal continuous positive airway pressure (CPAP) or bi-level positive airway pressure (Bi-PAP).
•Subjects have initiated pulmonary rehabilitation within the past 3 months.
•Subjects use oxygen \>= 2 liters per minute for \> 2 hours per day.
•Subjects require chronic or prophylactic treatment with antibiotics.

Outcomes

Primary Outcomes

effects of tiotropium bromide alone vs.the effect of tiotropium bromide and formoterol fumarate

Time Frame: 12 weeks

To compare the effects of tiotropium bromide alone vs. the effects of co-administration of tiotropium bromide and formoterol fumarate on the change from baseline of the normalized area under the time curve (AUC) for FEV1 for the 0 hour to 4 hours post-morning dose at the last study visit.