DeLand, Florida (PRWEB) November 12, 2012
According to the World Health Organization, COPD was the fifth leading cause of death worldwide in 2002 and is estimated to be the third leading cause by 2030 [WHO, 2010].
Are you a current or ex-smoker are suffering from a new or increased shortness of breath, cough, or congestion? If have COPD, Bronchitis, Emphysema or suffer from these symptoms this trial may fit for you.
Chronic obstructive pulmonary disease (COPD) has been defined as a preventable and treatable disease with some significant extra-pulmonary effects that may contribute to the severity in individual patients. The pulmonary component of COPD is characterized by airflow limitation that is not fully reversible, which is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases. COPD is a major cause of poor health, resulting in millions of deaths annually worldwide [GOLD, 2010] and contributing significantly to health care costs and morbidity [Chapman, 2006; Lopez, 2006].
This will be a Phase IIIb multi-center, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of a new drug versus an existing one, twice daily on lung function in COPD subjects.
Subjects will visit the clinic a minimum of 5 times over a 14-week period. Visit 5 will be an overnight stay in the clinic. A safety Follow-up Visit 6, 7 days post the last treatment study day will occur as a telephone contact. Subjects will be prescribed appropriate COPD therapy at the end of Treatment Visit 5 if required.
There are no plans to provide the study drug for compassionate use following study completion. The target enrolment across approximately 85 study centers is approximately 800 randomized subjects, to achieve approximately 680 who complete the 12-week treatment period. The total duration of subject participation will be approximately 15 weeks.
Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product or other study deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
Subjects eligible for enrolment in the study must meet all of the following criteria:
1. Informed consent: Subjects must give their signed and dated written informed consent to participate.
2. Gender: Males or females. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
3. Age: ≥40 years of age at Screening (Visit 1)
4. COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
5. Severity of Disease:
- Subject with a measured post-albuterol (salbutamol) FEV1/FVC ratio of ≤0.70 at Screening (Visit 1) [Pelligrino, 2005]
- Subjects with a measured post-albuterol (salbutamol) FEV1 ≤70% of predicted normal values calculated (via centralized vendor equipment) using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1).
Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol (salbutamol) via an MDI with a valved-holding chamber. The study-provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values.
6. Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history. Number of pack years = (number of cigarettes per day/20) x number of years smoked.
**Avail Clinical Research is now enrolling for this Paid COPD Clinical Trial. Learn more about COPD Awareness Month, or to get started visit http://www.availclinical.com or call us directly at (386) 310-1334.