Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272)

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: formoterol fumarate


Participation Criteria
=================
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. Subjects have significant renal, hepatic, cardiovascular (including cor pulmonale), metabolic, neurologic, hematologic, gastrointestinal, cerebrovascular or other significant medical illness or disorder which, in the judgment of the Investigator, may interfere with the study or require treatment which may affect the evaluation of efficacy and safety of the study drug. Subjects have clinically significant abnormalities on chest x-ray (other than evidence of COPD) at the Screening visit or within the previous year. Women are pregnant or breast-feeding. Subjects cannot adhere to the concomitant medications restrictions and prohibitions. Subjects have used any investigational product within 30 days, or 3 months for any biologic of unknown half-life, prior to the Baseline Visit (V3). Subjects are part of the staff or a family member of the staff personnel directly involved with this study. Subjects have chronic narrow-angle glaucoma. Subjects have symptomatic prostatic hyperplasia or bladder-neck obstruction.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: formoterol fumarate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of tiotropium bromide alone vs.the effect of tiotropium bromide and formoterol fumarate | 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. | 12 weeks |