AsthmaNCT01739387
A Study Assessing Patient Handling of Flutiform® Breath-Actuated Inhaler (BAI) and Flutiform® Pressurised Metered Dose Inhaler (pMDI)
An observational study of Asthma and COPD, run by Mundipharma Research Limited at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- Flutiform® pMDI and Breath Actuated Inhaler (BAI)
- Type of treatment
- Medical device
- How many people
- 332 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asthmas and COPD patients aged 12 and above obtained from primary care and advertising in Glasgow and Belfast areas.
Who may be able to join
- Written informed consent/assent.
- Male and female subjects ≥12 years old.
- Documented history of asthma or COPD for ≥ 6 months prior to screening visit.
- Subjects receiving ICS and LABA
- Can perform spirometry adequately.
- Willing and able to attend all study visits
Who cannot join
- Any severe chronic respiratory disease other than asthma and COPD.
- 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.
- Any serious neuromuscular disorder, or orofacial disease preventing the application of an inhaler to the mouth.
- Known sensitivity to inhaler propellant or excipients.
- Participation in a clinical drug study within 30 days of the screening visit.
- Current participation in a clinical study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
BioKinetic Europe Ltd
Belfast
Glasgow Clinical Research Facility
Glasgow
About this study
Official title: 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.
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.
Read the 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
- Being tested
- Flutiform® pMDI and Breath Actuated Inhaler (BAI)
- Keywords
- Flutiform®, Asthma, COPD
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutiform® pMDI and Breath Actuated Inhaler (BAI)Device
Both devices contain placebo
| Study group | Role | What they receive |
|---|---|---|
| Breath actuated inhaler (BAI) | Placebo. Two to nine puffs on one day only Receives: Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI) | |
| Flutiform® pMDI | Placebo. Two to nine puffs on one day only Receives: Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day only for each device
Secondary outcomes (4)
The percentage of subjects able to generate an adequate inspiratory flow to trigger the BAI.
Measured: 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
Measured: 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
Measured: 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
Measured: Each device will be used for one day only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739387
- Sponsor's protocol ID
- KFL9501
- Status last verified
- Jun 2013
- First submitted
- 14 Nov 2012
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28683212
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01739387
- Acronym / sponsor ID
- KFL9501
- Keywords
- Flutiform®, Asthma, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breath actuated inhaler (BAI) | – | Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI)Placebo. Two to nine puffs on one day only |
| Flutiform® pMDI | – | Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI)Placebo. Two to nine puffs on one day only |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asthmas and COPD patients aged 12 and above obtained from primary care and advertising in Glasgow and Belfast areas.
Key inclusion criteria (6 listed)
- Written informed consent/assent.
- Male and female subjects ≥12 years old.
- Documented history of asthma or COPD for ≥ 6 months prior to screening visit.
- Subjects receiving ICS and LABA
- Can perform spirometry adequately.
Key exclusion criteria (6 listed)
- Any severe chronic respiratory disease other than asthma and COPD.
- 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.
- Any serious neuromuscular disorder, or orofacial disease preventing the application of an inhaler to the mouth.
- Known sensitivity to inhaler propellant or excipients.
- Participation in a clinical drug study within 30 days of the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flutiform® pMDI and Breath Actuated Inhaler (BAI)Both devices contain placebo | Device | Breath actuated inhaler (BAI), Flutiform® pMDI |
Primary outcome
Measurement of successful device use (Flutiform® pMDI) versus (breath activated device (BAI))
Time frame: One day only for each device
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.
4 secondary outcomes
The percentage of subjects able to generate an adequate inspiratory flow to trigger the BAI.
Time frame: Each device will be used on one day only
The percentage of subjects with successful device use
Time frame: 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
Time frame: 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.
Time frame: Each device will be used for one day only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- Derived from this study: PubMed 28683212Bell 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and COPD, run by Mundipharma Research Limited at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of successful device use (Flutiform® pMDI) versus (breath activated device (BAI)) (time frame: One day only for each device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.