CURRENT OR FORMER SMOKERS WITH TROUBLE BREATHING AND/OR A PERSISTENT COUGH

Purpose of the study:

This clinical research study will assess the long-term efficacy and safety of the investigational study drug in the once-daily, maintenance treatment of bronchospasm (narrowing of the airways causing shortness of breath) in patients with chronic obstructive pulmonary disease (COPD).

Investigational study drug:

The investigational study drug is a once daily dose of indacaterol 150 micrograms. Indacaterol is a long-acting inhaled drug that is believed to act upon the smooth muscles of the airways. During bronchospasm, which is associated with COPD, these muscles involuntarily contract, causing constriction of the airways. Researchers will evaluate whether or not indacaterol can relax the smooth airway muscles and relieve bronchospasm, compared to currently marketed medications used to control COPD

Another inhaled medication called tiotropium will also be given during this study. Tiotropium has already been approved by the FDA and is marketed as Spiriva. During this study, 18 micrograms of tiotropium will be provided to be taken once a day with indacaterol for half the study participants. The other half of the study participants will receive 18 micrograms of tiotropium daily along with a placebo (containing inactive medication).

Rescue medication will be provided to all as back-up.

STUDY INFORMATION:

• There will be 12 weeks of study treatment, plus a 14 to 28 day screening period before treatment begins. There are 9 study visits. Visits 4 and 8 will be long visits, during which study participants will be at the study office for approximately 9 hours. The other visits will last approximately one hour each. Study procedures include physical exams, labwork, ECG's, and pulmonary function tests (PFT's).

• There is no charge for participation.

• A stipend will be provided to study participants for study related time and/or travel in the amount of $35 for Visits 2, 3, 5, 6, 7 & 9; $150 for Visits 4 & 8. Total possible = $510. Please note that there is no stipend for Visit 1/Prescreen.

• Investigator: Robert Benkert, M.D.

INCLUSION/EXCLUSION CRITERIA (Partial List):

• Male or female, at least 40 years old

• Must be a current or ex-smoker who has a smoking history of at least 10 pack years

• Must be in general good health

• Must be experiencing trouble breathing and/or a persistent cough

• May not be using oxygen for more than 15 hours per day

• Females able to become pregnant must be using birth control

• For other inclusion/exclusion criteria information, please talk with a study coordinator

FOR FURTHER INFORMATION, PLEASE CONTACT:

Study Coordinators:
Mary Reid, Cheri Casey, Jodi Frazier or Dara Stillman

Data Entry/Coordinator Assistant: Jenny Heit

Western States Clinical Research, Inc.
9201 W. 44th Avenue
Wheat Ridge, CO 80033

303-940-0909 Phone
303-940-0308 FAX

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Our mission is to promote the health and well-being of humanity by the development of new medicines through high-quality clinical research and a closely held philosophy of striving for excellence.

To find out about the studies that are currently underway at our office, please see Clinical Trials.

Western States Clinical Research Inc. specializes in research studies related to gastroenterology, asthma and allergy, pulmonology, internal medicine, ophthalmology and dermatology. Our website contains information for physicians, pharmaceutical companies and individuals interested in participating in clinical research.

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