Join New Pirfenidone Trial If You Have IPF

I received the below from the good folks at the Coalition for Pulmonary Fibrosis regarding the ASCEND trial opened to people with Idopathic Pulmonary Fibrosis. This is the second Pirfenidone trial, which seems so hopeful in treating pulmonary fibrosis. There are several people in my ILD Support Group who have been in the earlier trial and have shown amazing results.

The information below is about the new trial and, if you meet the criteria, how to be a part of this trial. All the information is below:

In an effort to keep you informed about active clinical trials in Pulmonary Fibrosis (PF), the Coalition for Pulmonary Fibrosis (CPF) would like to share updated information on the ASCEND trial, a Phase 3 trial investigating the potential therapeutic use of Pirfenidone. Please see information on the trial pasted for you below.  We also encourage you to see a listing of current Phase 1, 2 and 3 trials listed on our website at http://coalitionforpf.org/cpf_research_clinical.php  as well as the complete listing of PF related trials via www.clinicaltrials.gov.  

If you are a Pulmonary Fibrosis (PF) patient and would like to help find answers to PF, the CPF urges you to consider being involved in clinical trials. No treatments or cures can be discovered without these trials.  


If you are interested in being involved in the ASCEND trial, inform your physician and contact InterMune Medical Information at 1-888-486-6411.  If you're interested in other clinical trials, visit the CPF website's listing at http://coalitionforpf.org/cpf_research_clinical.php and use the contact information below the trial description for the trial in which you're interested.  


To view Frequently Asked Questions about Clinical trials, please refer to the National Institutes of Health (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. Call or email us - 1-888-222-8541, ext. 702 or tbarnes@coalitionforpf.org.  

Sincerely,

Mishka Michon, CPF Chief Executive Officer 

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