Status: Finalised First registered on: 04/11/2015
Last updated on: 01/10/2020
1. Study identification
EU PAS Register NumberEUPAS10753
Official titleReal life assessment of chronic obstructive pulmonary disease Inhaler devices handling
Study title acronymINHALER
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Professor
Last name MOLIMARD
First name Mathieu
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/03/2014
Start date of data collection01/09/201424/03/2015
Start date of data analysis15/12/201512/01/2016
Date of interim report, if expected
Date of final study report30/09/201630/09/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNOVARTIS PHARMA S.A.S.85
Charities
Government body
Research councils
EU funding scheme
OtherPublic University: Université de Bordeaux15
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name MOLIMARD
First name Mathieu
Address line 1Service de Pharmacologie - Université de Bordeaux - 146 Rue Leo Saignat
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557571560 
Alternative phone number 
Fax number (incl. country code)33557574671 
Email address mathieu.molimard@u-bordeaux.fr
Public Enquiries
Title Dr 
Last name MOLIMARD 
First name Mathieu 
Address line 1Service de Pharmacologie - Université de Bordeaux - 146 Rue Leo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557571560 
Alternative phone number 
Fax number (incl. country code)33557574671 
Email address mathieu.molimard@u-bordeaux.fr 
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