Status:
COMPLETED
To Study Device Attributes by Investigating Errors Made in Use, Ease of Use and Preference Among Different Inhalers in Subjects With Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is designed to assess the proportion of asthma subjects making critical and non-critical errors made in using ELLIPTA® inhaler compared with other commercially available inhaler devices suc...
Detailed Description
This is a non-interventional study and not an observational study and therefore some fields are not applicable for the CT.gov observational study design. It would be preferential to have the field pop...
Eligibility Criteria
Inclusion
- Informed consent: Subject must give their signed and dated written informed consent to participate; Subject understands and is willing, able, and likely to comply with study procedures and restrictions; Subject must be able to read, comprehend, and record information in Dutch and/or English
- Age: \>=18 years of age
- Gender: Male or female subjects.
- Asthma Diagnosis: A diagnosis of asthma as defined by the National Institutes of Health. Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
- Asthma treatment: All subjects should be currently receiving treatment for asthma.
- Must be naive to using ELLIPTA inhaler and at least one other inhaler device.
Exclusion
- Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of COPD only.
- Contraindications: A history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
- Subjects who are currently participating in another randomised pharmacological interventional trial.
- Inability to Read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT02195284
Start Date
November 1 2014
End Date
May 1 2015
Last Update
November 23 2015
Active Locations (4)
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1
GSK Investigational Site
Enschede, Netherlands, 7513 ER
2
GSK Investigational Site
Zutphen, Netherlands, 7207 AE
3
GSK Investigational Site
Portsmouth, United Kingdom, PO6 3LY
4
GSK Investigational Site
Southampton, United Kingdom, SO16 6YD