A Study Assessing Patient Handling of Flutiform® Breath-Actuated Inhaler (BAI) and Flutiform® Pressurised Metered Dose Inhaler (pMDI)
NCT ID: NCT01739387
Last Updated: 2013-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
332 participants
OBSERVATIONAL
2012-11-30
2013-06-30
Brief Summary
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Detailed Description
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Severity of disease will be determined by predicted FEV1. During the study subjects will be trained to use both the pMDI device and the BAI device being compared. Following training the subjects' use of each device will be assessed by a trainer/assessor using assessment criteria which cover handling, actuation and inhalation aspects for each of the devices under test. The order in which subjects receive each device will be determined using a randomisation schedule.
During the study subjects will continue to take their prescribed asthma or COPD medication. The pMDI and BAI devices used for the patient handling assessment will only contain placebo.
The duration of the study for a subject will be up to 58 days. Training and use of each device will be separated by 7 to 21 days
Conditions
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Keywords
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Breath actuated inhaler (BAI)
Placebo. Two to nine puffs on one day only
Flutiform® pMDI and Breath Actuated Inhaler (BAI)
Both devices contain placebo
Flutiform® pMDI
Placebo. Two to nine puffs on one day only
Flutiform® pMDI and Breath Actuated Inhaler (BAI)
Both devices contain placebo
Interventions
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Flutiform® pMDI and Breath Actuated Inhaler (BAI)
Both devices contain placebo
Eligibility Criteria
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Inclusion Criteria
2. Male and female subjects ≥12 years old.
3. Documented history of asthma or COPD for ≥ 6 months prior to screening visit.
4. Subjects receiving ICS and LABA
5. Can perform spirometry adequately.
6. Willing and able to attend all study visits
Exclusion Criteria
2. Evidence of a clinically unstable disease as determined by medical history or physical examination that, in the Investigator's opinion, precludes entry into the study or may confound between-period comparisons. 'Clinically unstable' is defined as any disease that, in the opinion of the Investigator, would put the Subject at risk through study participation.
3. Any serious neuromuscular disorder, or orofacial disease preventing the application of an inhaler to the mouth.
4. Known sensitivity to inhaler propellant or excipients.
5. Participation in a clinical drug study within 30 days of the screening visit.
6. Current participation in a clinical study.
12 Years
ALL
No
Sponsors
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Mundipharma Research Limited
INDUSTRY
Responsible Party
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Locations
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BioKinetic Europe Ltd
Belfast, , United Kingdom
Glasgow Clinical Research Facility
Glasgow, , United Kingdom
Countries
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References
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Bell D, Mansfield L, Lomax M. A Randomized, Crossover Trial Evaluating Patient Handling, Preference, and Ease of Use of the Fluticasone Propionate/Formoterol Breath-Triggered Inhaler. J Aerosol Med Pulm Drug Deliv. 2017 Dec;30(6):425-434. doi: 10.1089/jamp.2017.1385. Epub 2017 Jul 6.
Other Identifiers
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KFL9501
Identifier Type: -
Identifier Source: org_study_id