MF/F Safety Study in Adolescent and Adult Persistent Asthmatics
Research type
Research Study
Full title
A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 also known as P202)
IRAS ID
91444
Contact name
Janice Patrick
Contact email
Sponsor organisation
Schering-Plough Research Institute, a Division of Schering Corporation
Eudract number
2011-002142-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 7 months, 29 days
Research summary
Asthma is a condition in which the lining of the lungs and airways becomes irritated and inflamed (sore and swollen), making it difficult to breathe. Symptoms of asthma may include shortness of breath, chest tightness, wheezing and coughing. People with asthma are at risk for uncommon but serious problems that may be caused by worsening asthma, such as hospitalisation related to asthma, or dying from asthma. There are different types of medications used to treat asthma.
The study drug is an inhaled drug that contains two medications, namely mometasone furoate and formoterol. Mometasone furoate is an inhaled corticosteroid [ICS], and formoterol is a long-acting beta agonist [LABA], a type of bronchodilator.
This clinical study is being done to help answer an important safety question about one of the components of the study drug, specifically formoterol. Previous studies have raised concerns that patients taking LABA drugs have a higher risk of asthma-related hospitalisations and death. We do not know why this is, or if the addition of an ICS, such as mometasone furoate, reduces the increased risk of asthma-related hospitalisations and death.
This study is sponsored by Schering-Plough Research Institute (a subsidiary of Merck & Co. Inc.). Three other companies are running similar studies with other LABA drugs. Each trial will consist of approximately 11,700 asthmatic patients. In total, approximately 46,800 asthmatic patients, ages 12 and older, will participate in one of the four LABA-Safety trials in about 50 countries.
Patients who participate will be in the study for about 6 to 7 months and will visit the study centre approximately 5 times. Participants will take the study medication twice daily for approximately 26 weeks and their asthma symptoms will be monitored carefully at these visits and in-between by phone calls with the site. Participants will also need to complete a short daily diary by phone or on the internet.REC name
London - Dulwich Research Ethics Committee
REC reference
12/LO/0588
Date of REC Opinion
11 Jul 2012
REC opinion
Further Information Favourable Opinion