360° Coverage : Paid COPD Clinical Trial Now Enrolling at Avail Clinical...

Paid COPD Clinical Trial Now Enrolling at Avail Clinical Research Near Orlando, Florida; Accepting M/F Patients with COPD Age 40+

Avail is conducting a 24-week study to evaluate the effect of a once-daily experimental inhalation therapy on arterial stiffness compared to a placebo and another drug in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Sep 29 2013, 11:48am CDT | by PR.com

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.

Study Design
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.

Primary Objectives
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.

Inclusion Criteria
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)

Contact Information:
Avail Clinical Research
Jennifer Economou
(386) 785-2400 336
Contact via Email
www.availclinical.com

Read the full story here: http://www.pr.com/press-release/518663

Press Release Distributed by PR.com

Source: PR.com

 
 
 

blog comments powered by Disqus

Latest stories

Russia allows buffalo meat imports from India
Moscow, Dec 4 (IANS/TASS) Russia has allowed imports of buffalo meat from India, the country's veterinary regulator said Thursday.
 
 
New guidelines for prostate cancer testing
Melbourne, Dec 4 (IANS) Prostate cancer checks in Australia are set to improve after cancer agencies and health experts reached an agreement on new testing guidelines at the World Cancer Congress (WCC) currently being held in Melbourne.
 
 
Australian researcher discovers first artwork by early human
Sydney, Dec 4 (IANS) An Australian researcher has discovered what is believed to be the first artwork created by a human.
 
 
Insects compete with rats to clear garbage
New York, Dec 4 (IANS) Insects play a very important role in cleaning up cities and they compete with other pests like rats and pigeons in their endeavour, a study has said.
 
 
 

Latest from the Network

Australian researcher discovers first artwork by early human
Sydney, Dec 4 (IANS) An Australian researcher has discovered what is believed to be the first artwork created by a human. The simple zigzag pattern found on a fossilized shell from the Indonesian island of Java has...
Read more on Celebrity Balla
 
Insects compete with rats to clear garbage
New York, Dec 4 (IANS) Insects play a very important role in cleaning up cities and they compete with other pests like rats and pigeons in their endeavour, a study has said. Scientists sampled arthropods - such as...
Read more on Business Balla
 
School headmaster shot dead in Pakistan
Islamabad, Dec 4 (IANS) Unidentified gunmen Thursday killed the headmaster of a private school in Pakistan's Balochistan province. Police officials said the armed men opened fire at the vehicle of Zahid Ali,...
Read more on Politics Balla
 
Four more bodies recovered from sunken South Korean ship
Seoul, Dec 4 (IANS) Four more bodies were recovered Thursday from a sunken South Korean fishing ship in the Bering Sea, the foreign ministry here said. This increased the toll to 16, including six South Koreans and 10...
Read more on Politics Balla
 
Lesbian couple asked to desist in London restaurant
London, Dec 4 (IANS) A lesbian couple in a London restaurant was asked to desist by a staff member, who asked them to "stop what you are doing". Lydia Cawson, 29, said that she and her girlfriend were asked by a staff...
Read more on Politics Balla
 
Oxford Dictionaries to add 1,000 new words
London, Dec 4 (IANS) 'Mamil' (middle-aged man in Lycra), 'silvertail' (a person who is socially prominent or who displays social aspirations) and 'crony capitalism' are among the 1,000 new words to be added to...
Read more on Celebrity Balla
 
Oceans play key role in global 'warming hiatus'
London, Dec 4 (IANS) Increased heat uptake across three oceans - North Atlantic, the Southern Ocean and Equatorial Pacific Ocean - is the likely cause of the 'warming hiatus' -- the current decade-long slowdown in...
Read more on Politics Balla
 
Novel imaging to identify if TB drugs are working
Washington, Dec 4 (IANS) Tuberculosis patients who are not cured of the infection can develop multi-drug resistant TB and have to take as many as six drugs for two years. Now, researchers at University of Pittsburgh...
Read more on Business Balla
 
PM makes first appointment to High Court of Australia
Canberra, Dec 4 (IANS) Prime Minister Tony Abbott's government Thursday appointed former Victorian Supreme Court judge Geoffrey Nettle as the next Justice of the High Court of Australia. Attorney General George...
Read more on Politics Balla
 
18 suspected militants killed in Pakistan airstrikes
Islamabad, Dec 4 (IANS) At least 18 suspected militants were killed Thursday in airstrikes conducted by Pakistan Air Force fighter jets in North Waziristan. According to officials, the airstrikes were conducted in...
Read more on Politics Balla