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Therapeutic Areas: Pulmonary/Respiratory Diseases | Trauma/Emergency Medicine | Immunology/Infectious Diseases
Disease Category: COPD (Chronic Obstructive Pulmonary Disease)

Trial Information

Current or former smokers with trouble breathing and/or a persistent cough

We are looking for people at least 40 years old to participate in a clinical research trial of a once a day inhaled investigational study medication to be used in combination with an FDA approved inhaled marketed chronic obstructive pulmonary disease (COPD) medication.

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 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 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.
• Principal Investigator: Robert Benkert, M.D.

Patient Inclusion 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
• Females able to become pregnant must be using birth control
• For other inclusion/exclusion criteria information, please talk with a study coordinator

Patient Excluson Criteria:
PARTIAL LIST...

• May not be using oxygen for more than 15 hours per day
• For other inclusion/exclusion criteria information, please talk with a study coordinator

Cheri Casey, Mary Reid, Jodi Frazier, Dara Stillman, Jennifer Heit, Study Coordinators
Western States Clinical Research, Inc.
9201 W. 44th Avenue
Wheat Ridge, CO 80033
Phone: 303-940-0909
Fax: 303-940-0308
EMail: research@wscrinc.com

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