Trials / Completed
CompletedNCT01739387
A Study Assessing Patient Handling of Flutiform® Breath-Actuated Inhaler (BAI) and Flutiform® Pressurised Metered Dose Inhaler (pMDI)
A Randomised, Open-label, Cross-over Study of Flutiform® BAI and Flutiform® pMDI Devices in Adolescents and Adult Subjects With Persistent Asthma or Chronic Obstructive Pulmonary Disease (COPD) to Assess Patient Handling.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 332 (actual)
- Sponsor
- Mundipharma Research Limited · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Flutiform® pMDI and Breath Actuated Inhaler (BAI) | Both devices contain placebo |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2012-12-03
- Last updated
- 2013-06-28
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01739387. Inclusion in this directory is not an endorsement.