Status:
COMPLETED
Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
This is a randomised, open-label, placebo, crossover, multicentre study with a single visit. The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo) via the ELLIPT...
Eligibility Criteria
Inclusion
- Informed consent: Subject must give their signed and dated written informed consent to participate in the study; 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: \>=40 years of age
- Gender: Male or female subjects.
- Primary diagnosis of COPD: subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society. Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
- COPD treatment: All patients should be currently receiving treatment for COPD.
- Must be naïve to using ELLIPTA inhaler and at least one other inhaler device. Subjects who are naïve to the BREEZEHALER and HANDIHALER inhalers must be naïve to all other inhaler devices that requires a capsule.
Exclusion
- Asthma: Subjects with a current diagnosis of asthma only. Note: Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
- 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 :
August 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2015
Estimated Enrollment :
569 Patients enrolled
Trial Details
Trial ID
NCT02184624
Start Date
August 28 2014
End Date
July 31 2015
Last Update
May 23 2017
Active Locations (8)
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1
GSK Investigational Site
Almere Stad, Netherlands, 1311 RL
2
GSK Investigational Site
Beek, Netherlands, 6191 JW
3
GSK Investigational Site
Enschede, Netherlands, 7513 ER
4
GSK Investigational Site
Kloosterhaar, Netherlands, 7694 AC