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This study will compare the patient handling of Flutiform® pMDI (pressurised metered dose inhaler) and a breath activated device (BAI). Patient handling will be assessed using assessment criteria which detail the correct handling steps for each inhaler.
Approximately 340 subjects aged 12 years and over who have asthma or chronic obstructive pulmonary disease (COPD), and are on medication for their condition will be recruited for the study. Subjects will be recruited to ensure that different severities of disease are included in the study.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breath actuated inhaler (BAI) | Placebo. Two to nine puffs on one day only |
| |
| Flutiform® pMDI | Placebo. Two to nine puffs on one day only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flutiform® pMDI and Breath Actuated Inhaler (BAI) | Device | Both devices contain placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of successful device use (Flutiform® pMDI) versus (breath activated device (BAI)) | This study compares our Flutiform® pMDI (pressurised metered dose inhaler) containing placebo only and a breath activated device (BAI), containing placebo only. The percentage of subjects will be measured who have successful device use using an 8 point scale. | One day only for each device |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects able to generate an adequate inspiratory flow to trigger the BAI. | Each device will be used on one day only | |
| The percentage of subjects with successful device use | This is defined as all critical steps being correctly performed - Steps 2, 4 - 6 for pMDI; Steps 2, 4 - 7 for BAI; on an 8 point scale |
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Inclusion Criteria:
Exclusion Criteria:
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Asthmas and COPD patients aged 12 and above obtained from primary care and advertising in Glasgow and Belfast areas.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioKinetic Europe Ltd | Belfast | United Kingdom | ||||
| Glasgow Clinical Research Facility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28683212 | Derived | 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. |
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| Each device will be used for one day only |
| The percentage of subjects unable to be trained to use the device successfully within 15 minutes | Each device will be used on one day only |
| The percentage of subjects able to perform 7, 6, 5, 4, 3, 2, and 1 step successfully. | Measured on an 8 point scale | Each device will be used for one day only |
| Glasgow |
| United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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