RIDGEFIELD, Conn., Dec. 14, 2015 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced the initiation of a new 12-week study (ClinicalTrials.gov Identifier: NCT02579603) to assess the safety, tolerability and pharmacokinetics of add-on treatment with pirfenidone to background therapy with OFEV, versus OFEV taken alone, in people with idiopathic pulmonary fibrosis (IPF). The trial's primary endpoint is percentage of people with on-treatment gastrointestinal (GI) side effects from baseline to week 12.
"Boehringer Ingelheim has a long-standing and continued commitment to addressing the significant unmet needs of people affected by serious respiratory diseases like IPF," said Danny McBryan, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "This trial is being initiated to provide the scientific and healthcare communities with important information about the safety of OFEV when combined with another FDA-approved treatment for IPF."
IPF is a rare and serious lung disease that causes permanent scarring of the lungs. It affects as many as 132,000 Americans, typically men over the age of 65. Early diagnosis and proper care are critical to helping people treat their condition.
"Last year's FDA approval of the first two treatment options for IPF, followed shortly by their conditional recommendation in International Treatment Guidelines*, represented major accomplishments in treating this devastating disease," said Lisa H. Lancaster, M.D., associate professor of the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University Medical Center. "At the same time, healthcare providers have limited evidence of the safety of combining these two treatments and the results from this new trial will provide important information to improve the understanding of how these drugs may be able to be used together."
About trial 1199.222 (ClinicalTrials.gov Identifier: NCT02579603)
A 12-week, open-label, randomized, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral OFEV when taken in combination with oral pirfenidone, compared to treatment with OFEV alone, in people with IPF.
Enrollment for trial 1199.222 started on November 2, 2015. The study will will enroll approximately 100 people with confirmed IPF from 25 study centers in the United States, Canada, Italy, Germany, France and the Netherlands. To be eligible for enrollment people must be forty years or older with an IPF diagnosis. This may include patients previously treated with OFEV without drug-related adverse effects. Full criteria are available at clinicaltrials.gov.
The primary endpoint is percentage of people with on-treatment GI side effects from baseline to week 12, as using combined therapies may increase the chance of having side effects. On-treatment side effects are defined as side effects with an onset from the first dose of randomized treatment up to the last dose of randomized treatment. The study does not assess efficacy.
As a secondary endpoint, the amount of OFEV and pirfenidone circulating in the blood will be measured during the trial in order to assess if pirfenidone interacts with OFEV and influences the amount found in the blood.
Eligible participants will be randomized to receive OFEV 150 mg twice daily or OFEV 150 mg twice daily combined with pirfenidone (titrated up to a dose of 801 mg three times daily). During the 12-week randomized treatment period, symptomatic treatment, dose reductions and/or temporary interruptions are allowed for both drugs in case of side effects. Each person's participation in the trial is estimated to last a total of approximately 21-25 weeks.
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*The conditional recommendation by the ATS/ERS/JRS/ALAT International Treatment Guidelines Committee means that a majority of people may follow the recommendation but some people may not. Additionally, clinicians must discuss preferences with their patients to help reach treatment decisions consistent with their values and preferences.
About OFEV® (nintedanib) capsules
The U.S. Food and Drug Administration (FDA) approved OFEV for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. OFEV is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.
The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW™ trial (NCT00514683) and the Phase III INPULSIS™ trials (INPULSIS™-1 and INPULSIS™-2; NCT01335464 and NCT01335477). All these studies were randomized, double-blind, placebo-controlled trials comparing OFEV 150 mg twice daily to placebo for 52 weeks. Both INPULSIS™ trials were identically designed while the TOMORROW™ study design was similar.
What is OFEV?
OFEV is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). It is not known if OFEV is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about OFEV (nintedanib)?
OFEV can cause harm, birth defects or death to an unborn baby. Women should not become pregnant while taking OFEV and should use birth control during and for at least 3 months after your last dose. If you become pregnant while taking OFEV, tell your doctor right away.
What should I tell my doctor before using OFEV?
Before you take OFEV, tell your doctor if you have:
- liver problems
- heart problems
- a history of blood clots
- a bleeding problem or a family history of a bleeding problem
- had recent surgery in your stomach (abdominal) area
- are a smoker. You should stop smoking prior to taking OFEV and avoid smoking during treatment.
- have any other medical conditions.
Tell your doctor if you:
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You and your doctor should decide if you will take OFEV or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John's wort. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.
What are the possible side effects of OFEV?
OFEV may cause serious side effects, including:
- Liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal or feeling tired. Your doctor will do blood tests regularly to check how well your liver function is working during your treatment with OFEV.
- Diarrhea, nausea, and vomiting. Tell your doctor if you have these symptoms or if they do not go away or become worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements that can cause diarrhea. While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects.
- Heart attack. Tell your doctor right away if you have symptoms of a heart problem which may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
- Stroke. Tell your doctor right away if you have symptoms of a stroke which may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
- Bleeding problems. OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal. Tell your doctor if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
- Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
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Name: Jennifer Forsyth
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.