DeLand, FL, September 29, 2013 --(PR.com
)-- To see if you qualify for this COPD Clinical Trial in Florida, visit Avail Clinical Research on the web (http://www.availclinical.com) or contact us directly at (386) 785-2404. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This study is designed to evaluate the effect of an experimental inhalation therapy administered once daily via a Novel Dry Powder Inhaler on arterial stiffness compared with placebo and vilanterol over a 24 - week treatment period in subjects with COPD. Vilanterol is included to help explain relative treatment effect of this experimental inhalation therapy in the new combination, however the comparison is not powered. Arterial stiffness will be measured as aPWV. This is a randomised, placebo-controlled, multicenter study. Subjects who meet the eligibility criteria at Screening and meeting the randomisation criteria at the end of a 2-week Run-In period will enter a 24-week treatment period. There will be an approximately 7-day Follow-Up period after the treatment period.
Background & Rationale
Arterial stiffness is increasingly recognized as a surrogate marker for cardiovascular disease (CVD). In particular, arterial stiffness has been shown to be an independent predictor of future fatal and non-fatal CV events and all-cause mortality in hypertensive patients, apparently healthy elderly subjects and a general population. Arterial stiffness can be measured with non-invasive, reproducible and inexpensive techniques, which make it feasible to implement into clinical practice and large-scale clinical studies.
The primary objective of the study is to evaluate the effect of an experimental inhalation therapy administered once daily (QD) compared with placebo on aPWV in subjects with COPD and aPWV ≥ 11.0 m/s at baseline.
1. Type of subject: outpatient
2. Informed consent: Subjects must give their signed and dated written informed consent to participate.
3. Gender: Male or female subjects
A female is eligible to enter and participate in the study if she is of:
-Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile).
-Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly:
-- Complete abstinence from intercourse from screening until the Follow-Up Phone Contact; or
-- Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
-- Implants of levonorgestrel inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
-- Injectable progestogen administered for at least 1 month prior to study medication administration and administered until the Follow-Up Phone Contact; or
-- Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
-- Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal agent (foam/gel/film/cream/suppository); or
-- An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1 per year; or
-- Estrogenic vaginal ring; or
-- Percutaneous contraceptive patches
4. Age: ≥40 years of age at Screening (Visit 1)
5. COPD diagnosis: Subjects with a clinical history of COPD
6. Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening
7. Severity of Disease:
Subjects with a measured post-albuterol/salbutamol FEV1 ≤70% of predicted normal values calculated using NHANES III reference equations at Screening (Visit 1)
Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 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.
8. Baseline aPWV: subjects with a measured aPWV≥11.0 m/s at Screening (Visit 1)