Multicenter, open-label, non-interventional study to evaluate the impact on clinical effects, user-friendliness and patient's acceptance of Airflusal® Forspiro® in the treatment of asthma under real life conditions (ASSURE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28028
• EU PAS number:
  EUPAS12236
• Study ID:
  28028
• Official title and acronym:
  Multicenter, open-label, non-interventional study to evaluate the impact on clinical effects, user-friendliness and patient's acceptance of Airflusal® Forspiro® in the treatment of asthma under real life conditions (ASSURE)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Norway

  Sweden
• Study description:
  Asthma is the single most common chronic disease among children, and also affects many adults. It is a significant public health problem and a high-burden disease for which prevention is partly possible and treatment can be effective. According to the international ERS/ATS guidelines on definition, evaluation and treatment of severe asthma, combination preparations of inhaled steroids and long-acting beta agonists – fixed combinations - have been firmly established treatments for bronchial asthma for years. With Airflusal® Forspiro® the proven combination of the steroid fluticasone (as propionate) and the long-acting beta agonist salmeterol (as xinafoate) is available in a newly developed inhaler. For successful therapy with inhaled pharmaceutical forms, it is essential for the inhalation technique to be correct. The non-interventional study ASSURE is firstly to assess the patients' asthma control and quality of life while using Airflusal® Forspiro® in everyday practice, when used for bronchial asthma according to the guidelines. Secondly, the study is to obtain information concerning patient acceptance and the user-friendliness of the new Forspiro® inhaler in normal conditions outside of clinical studies.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sandoz

Multiple centres: 300 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 24/02/2014

Actual: 24/02/2014

Study start date

Planned: 01/10/2014

Actual: 30/10/2014

Date of final study report

Planned: 30/06/2017

Actual: 03/08/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sandoz International GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable