New Clinical Study of Pirfenidone in Australia, New Zealand, Mexico, US and South America

Once again, the marvelous people from The Coalition for Pulmonary Fibrosis has sent an e-mail regarding the new clinical trial now enrolling people with Idiopathic Pulmonary Fibrosis. This is an international study on the drug pirfenidone. There are several people in my ILD Support Group who have been on this drug for years and say they feel it has been very positive. Remember, it is now available in Japan, Europe and India. Really, it's time for it to be made available to other countries as well.


The parameters of being accepted into the study are below. Also, there is a web site for further information.   Here it is:


"If you are a Pulmonary Fibrosis (PF) patient and would like to help find answers to PF, the Coalition for Pulmonary Fibrosis (CPF) urges you to consider being involved in clinical trials. No treatments or cures can be discovered without these trials.
One important trial is being conducted is the ASCEND Trial.  ASCEND is a large clinical trial currently enrolling patients in the United States, Mexico, Australia, New Zealand, and select South American countries. This trial is designed to assess the efficacy and safety of the investigational use of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF).
There is a full listing of PF clinical trials on the CPF website at: http://coalitionforpf.org/cpf_research_clinical.php. 
To view Frequently Asked Questions about Clinical trials, please refer to the NIH website on the subject at:http://clinicaltrials.gov/ct2/info/understand.  Please also feel free to contact the CPF with questions about the trials.
Sincerely,
Mishka Michon, CEO of the CPF


ASCEND is a large clinical trial currently enrolling patients in the United States, Mexico, Australia, New Zealand, and select South American countries. This trial is designed to assess the efficacy and safety of the investigational use of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF).
What Treatment is Being Tested?
Eligible patients will receive either pirfenidone (an investigational medication for IPF in the U.S., Mexico, Australia, New Zealand, and select South American countries) or placebo for one year (52 weeks). Patients who complete the entire 52-week study period will be offered the opportunity to continue taking pirfenidone treatment (or switch from placebo to pirfenidone) as part of an open-label rollover study. Patients may also be offered participation in the rollover study if they are able to follow their dosing regimen during the initial clinical trial.
Objectives
Clinical trials must be designed to address specific objectives. The objectives of the ASCEND Trial are to:
• Assess the effect of pirfenidone compared with placebo on change in a lung function measure (percent predicted forced vital capacity, or %FVC)
• Assess the safety of pirfenidone compared with placebo
Select Inclusion Criteria
Clinical trials must also set specific criteria for patient enrollment. To participate in the ASCEND Trial, the main requirements are:
• The diagnosis of IPF (definite or probable) must have been made within 4 years (48 months) of study randomization — the time at which patients will be randomly assigned to receive either pirfenidone or placebo
• At the time of study randomization, the patient must be between 40 and 80 years of age
• Lung function, measured by a test of the ability to exhale (forced vital capacity, or FVC) must fall within a specific range (50% to 90%)
• Another measure of lung function, called carbon monoxide diffusing capacity (DLCO), must be within the range of 30% to 90%
• The patient must be able to walk at least 150 meters (about 500 feet) within 6 minutes
Select Exclusion Criteria
In order to produce scientifically meaningful results, the ASCEND Trial cannot admit all people with IPF. Patients with any of the following criteria are not eligible to participate in the ASCEND Trial:
• At the time of study randomization, the patient is either expecting to receive a lung transplant within one year or, for patients in the United States, is on a lung transplant waiting list
• The interstitial lung disease has a known explanation
• There is a history of asthma or chronic obstructive pulmonary disease
• The patient has an active infection
• The patient is already receiving ongoing IPF treatment such as an investigational therapy, immunosuppressant, or a cytokine modulating agent
• Within the past 6 months, the patient has had unstable or deteriorating cardiac disease or a pulmonary disease other than IPF
• History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
Study Details:
• Screening period (up to 56 days)
• 52 Week Treatment Period
• All treatment-compliant patients who complete 52 weeks will be offered participation in an open-label rollover study
Learn More About the ASCEND Trial
If you would like more detailed information about the ASCEND Trial, please go to www.ascendtrial.com, or call InterMune Medical Information at 1-888-486-6411"