Status:
COMPLETED
Handling Inhalers - Technique Error Comparison (HI-TEC)
Lead Sponsor:
Research in Real-Life Ltd
Collaborating Sponsors:
Sanofi
Conditions:
Pulmonary Disease, Chronic Obstructive
Asthma
Eligibility:
All Genders
18-75 years
Brief Summary
Randomised, cross sectional, observational study evaluating inhaler device critical errors (errors that could affect dose delivery to the lungs) for the Pulmojet inhaler compared to Diskus or Turbuhal...
Detailed Description
Single-visit, randomised, crossover, open-label study comparing critical device handling errors for the Pulmojet compared to Diskus with Turbohaler in patients receiving maintenance inhaled corticoste...
Eligibility Criteria
Inclusion
- Patient is aged over 18
- Patient has an asthma and/ or COPD diagnosis
- Patient is receiving current therapy including either inhaled corticosteroids (ICS) or fixed dose combination ICS/ Long acting Beta-agonists(FDC ICS/LABA's)
- The patient's current therapy is being administered through a metered dose inhaler (MDI), Turbuhaler or Diskus device
- Patients must be able and willing to read and comprehend written and verbal instructions
- After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study
- All Turbuhaler and MDI patients are required to have no use of the Diskus device in the past year
- All Diskus patients are required to have no use of the Turbuhaler device in the past year
Exclusion
- Current therapy with ICS or ICS/LABA in any device other than a Diskus, Turbuhaler or metered dose inhaler (MDI)
- An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study
- Patient has received oral steroids and/or antibiotics for a lower respiratory condition (identified using lower respiratory diagnoses) in the 4 weeks preceding the study (used as a proxy measure for identifying an exacerbation and / or lower respiratory infection, which might suggest altered inspiratory capabilities)
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT01794390
Start Date
September 1 2013
End Date
March 1 2014
Last Update
October 27 2015
Active Locations (1)
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1
UK GP sites
Cambridge, United Kingdom