A prospective, multicentre, non-interventional study to collect further data on the safety and effectiveness of a new combination of formoterol and fluticasone in a pMDI with HFA 227 as the propellant, in subjects with mild to moderate-severe asthma. (FLT9501)

Study identification

• EU PAS number:
  EUPAS3702
• Study ID:
  15258
• Official title and acronym:
  A prospective, multicentre, non-interventional study to collect further data on the safety and effectiveness of a new combination of formoterol and fluticasone in a pMDI with HFA 227 as the propellant, in subjects with mild to moderate-severe asthma. (FLT9501)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This non-interventional observational study was conducted to complement the results from randomized controlled trials by examining outcomes across the diverse spectrum of community-based patients with asthma. The parameter of interest are the safety and effectiveness of the new combination of fluticasone and formoterol (flutiform®) with HFA 227 as the propellant in patients with mild to moderate severe asthma in routine clinical practice. In this study the collection of data are the exposure to flutiform® and the evaluation of asthma control and the frequency of adverse events associated with flutiform® HFA 227 or which are known to be side effects of the treatment with other LABA/ICS combination drugs. The effectiveness evaluation will include the amount of rescue medication use, discontinuation due to lack of efficacy, flutiform® dose adjustment (step up, step down), amount of oral or parenteral corticosteroid use, asthma exacerbations and lung function parameters as reported by the patient or assessed during routine clinical practice at the physicians discretion. It is planned to observe 1500 patients in Germany in a time frame for one year.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pneumologische Schwerpunktpraxis Kroker Schaeben Schmidt

Study timelines

Date when funding contract was signed

Planned: 31/10/2011

Actual: 31/10/2011

Study start date

Planned: 01/03/2012

Actual: 15/11/2012

Data analysis start date

Planned: 01/07/2015

Actual: 05/10/2015

Date of final study report

Planned: 31/05/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Mundipharma GmbH

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)