M/34273/41, Almirall, COPD, Breezhaler vs. Genuair
Research type
Research Study
Full title
Study evaluating preference, satisfaction and ease of use of Genuair® (Pressair®) and Breezhaler® (Neohaler®) inhalers in chronic obstructive pulmonary disease (COPD) diagnosed patients
IRAS ID
125902
Contact name
John Haughney
Contact email
Sponsor organisation
Almirall S.A.
Research summary
COPD (chronic bronchitis or emphysema) is a common lung condition, often associated with cigarette smoking. People with COPD often suffer shortness of breath, cough and recurring chest infections, known as exacerbations. Medicines through inhalers are the mainstay of treatment. To ensure medicines get to the lungs, it is important that patients can use, and are happy using, inhaler devices.
The study will be conducted in three countries (Germany, Spain and United Kingdom), with two study centres per country. A total of 120 patients will be included in this clinical study. Male and female patients aged 40 years and older with stable COPD, who use COPD medication and meet the inclusion/exclusion criteria are eligible. All patients will receive the two inhalers which are being studied and compared, the Genuair® and Breezhaler® inhalers. These will only contain placebo (dummy) medication.
Patients will be recruited over a period of approximately 3 months. Since the duration each subject’s participation in the study will be 2 weeks, the study is expected to last approximately 3.5 months. Patient’s preference, satisfaction and correct use of both inhaler devices will be evaluated using the inhaler devices. Patients will complete the Patient Satisfaction and Preference Questionnaire (PASAPQ) at the end of the study.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0266
Date of REC Opinion
16 Aug 2013
REC opinion
Favourable Opinion