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

Trial Information

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Pharmacodynamics, Efficacy, and Safety of 50 mg Tetomilast Administered as Oral Tablets in Patients with Chronic Obstructive Pulmonary Disease Associated with Emphysema

be asked to watch and to rate your symptom score daily for shortness of breath, cough, and sputum.

At certain times throughout the study, you will record your uses of rescue medications and your lung function symptoms in diaries that the study doctor or study staff will give to you. The study doctor or study staff will tell you more about how and when to use these diaries, and when you must return them.

You will be asked to complete a questionnaire called the St. George’s Respiratory Questionnaire (SGRQ). The questionnaire is used to learn how you are feeling based on your COPD. The questionnaire must be completed before you receive your first dose of study drug and at Weeks 26, 52, 78, and 104.

You agree to follow the instructions provided to you by the staff and to return here for appointments over the 2-year period of the study. The study doctor will study your response to the study drug. These are the scheduled visits for your appointments and tests:

• Your first day when you will receive the study drug, and then Weeks 2, 4, 13, 26, 39, 52, 65, 78, 91, and Week 104. We will call you about 2 weeks after you have taken your last dose of study drug to check on you.

If you are a female that can become pregnant, you must be prepared to and agree to use two methods (double-barrier) of birth control. You must use two methods starting from your screening visit. If you are a female, you must use these birth control methods until 30 days after your last dose of study drug. If you are a male, you must use these birth control methods until 90 days after your last dose of study drug. Two of the following precautions must be used: tubes tied (tubal ligation), male sterilization (vasectomy), vaginal diaphragm, intrauterine device (IUD), birth control pills, birth control implant, or condom or sponge with spermicide. Your study doctor will provide you with general information, information about pregnancy prevention, information about other drugs that may affect hormonal contraceptives that you may be taking, information about contraceptives that are in current use, and the guidelines that we will follow should you become pregnant during this study.

Ages Eligible for Study: 40 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female, 40-65 yrs old,inclusive.
• Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT.
• FEV1: FVC greater than 70% predicted.
• At least 1 documented COPD exacerbation within the past year but not within 8 weeks of randomization.
• Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening.

Exclusion Criteria:

• Patients with asthma, active tuberculosis or bronchieectasis.
• A respiratory tract infection within 30 days prior to the screening visit.
• Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer.
• Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.
• Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization.
• Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit.
• Subjects taking anticoagulants.

Fu, LiYi
Pulmonary Associates, PA
1112 East McDowell Road
Phoenix, AZ 85006
Phone: 602-346-4747
Fax: 602-258-1113
EMail: palyf@aol.com

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