Overview

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

Status:
Completed
Trial end date:
2006-11-21
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Collaborators:
Integrated Therapeutics Group
Novartis
Treatments:
Bromides
Formoterol Fumarate
Tiotropium Bromide
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.