Real life assessment of chronic obstructive pulmonary disease Inhaler devices handling (INHALER)

04/11/2015
22/02/2024
EU PAS number:
EUPAS10753
Study
Finalised
Study summary
No information provided.
Study identification

EU PAS number

EUPAS10753

Study ID

37451

Official title and acronym

Real life assessment of chronic obstructive pulmonary disease Inhaler devices handling (INHALER)

DARWIN EU® study

No

Study countries

France

Study description

The correct use of inhalation devices is essential to ensure the effectiveness of the treatment (Giraud and Roche, Eur Respir J 2002). We have shown in a large study published in 2003 that many patients make handling errors in real life (Molimard et al., J Aerosol Med 2003, Girodet et al., Therapie 2003). Since this study, new devices have been marketed in chronic obstructive pulmonary disease (COPD), including Breezehaler® and Respimat®. Interestingly, little is known regarding their real-life use. The aim of this study is to update data on device handling, including new devices, in a real-life setting in France. The primary objective is to evaluate real-life COPD patient handling of their usual inhaler (Breezhaler®, Diskus®, Handihaler®, Respimat®, Turbuhaler® or pressurized Metered Dose Inhaler) by general practitioners or pulmonologists.For this cross-sectional observational study, 1 000 GPs and 200 pulmonologists randomly selected from a geographically representative database, and who agree to participate in this study, will assess patient handling of their current inhaler. Five thousands patients will be requested to take a puff of their usual inhaler using their usual technique, which will be observed and rated by the physician. Patient characteristics, COPD history, and device use history, will be collected using a questionnaire. For each device (if a patient has several devices, each device will be studied) descriptive statistical analysis will be performed: the handling error rate will be estimated overall (handling errors will be classified as those independent or dependent of the inhalation system, and among the latter major/critical errors will be identified), as well as stratified according to patient characteristics, COPD history, device use history, and patient-reported treatment effect. Sensitivity analyses will be performed excluding patients having been trained within 3 months.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Mathieu MOLIMARD

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other
Pharmaceutical company and other private sector 

More details on funding

NOVARTIS PHARMA S.A.S., Public University: Université de Bordeaux
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable