Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01385696
Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients
A Phase 3 study testing Genuair® (Almirall S.A.) and HandiHaler® (Boehringer Ingelheim's) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Almirall, S.A. at 4 sites in 2 countries.
Trial summary
Preference study: Genuair vs HandiHaler inhalers in COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Genuair® (Almirall S.A.) and HandiHaler® (Boehringer Ingelheim's)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2011to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patients aged ≥ 40 with stable COPD
- Naïve patients to the use of study inhalers
- Patients agreeing on participating and signing the Informed Consent Form
Who cannot join
- Patients with other clinically significant disease, particularly body malformations or diseases affecting coordination and/or motor system
- Patients unable to read product package instructions and answer patient reported questionnaires
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Almirall investigative site 3
Bonn, 53119
Almirall investigative site 5
Koblenz, 56068
Netherlands2 sites
Almirall investigative site 1
Enschede, 7511 JX
Almirall investigative site 2
Zutphen, 7207 AE
About this study
Official title: Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in COPD Diagnosed Patients
Preference study: Genuair vs HandiHaler inhalers in COPD patients.
- Being tested
- Genuair® (Almirall S.A.), HandiHaler® (Boehringer Ingelheim's)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genuair® (Almirall S.A.)Device
Inhaler with only placebo, once daily, 14 days
HandiHaler® (Boehringer Ingelheim's)Device
Inhaler with only placebo, once daily, 14 days
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Genuair first, HandiHaler second Receives: Device: Genuair® (Almirall S.A.); Device: HandiHaler® (Boehringer Ingelheim's) |
| group B | Experimental | HandiHaler first, Genuair second Receives: Device: Genuair® (Almirall S.A.); Device: HandiHaler® (Boehringer Ingelheim's) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2
Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)
Measured: 14 days
Secondary outcomes (2)
Mean Overall Satisfaction With Genuair and Handihaler at Visit 2
The patient will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 [very dissatisfied] to 5 [very satisfied]) after 2 weeks of daily practice (visit 2)
Measured: 14 days
Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2
The correct use of devices will be assessed measuring the errors made by patients when using each device after 2 weeks of daily practice (visit 2).
Critical error is defined as the one that compromise the potential benefit of the treatment such as those that impede drug deposition in the lungs or delivery of sufficient dose.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordi Estruch, Head of GMA, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385696
- Sponsor's protocol ID
- M/34273/32
- Status last verified
- May 2015
- First submitted
- 17 Jun 2011
- Last updated
- 24 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in COPD Diagnosed Patients
- ClinicalTrials.gov ID
- NCT01385696
- Acronym / sponsor ID
- M/34273/32
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Posted 22 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preference study: Genuair vs HandiHaler inhalers in COPD patients.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: Genuair® (Almirall S.A.), Device: HandiHaler® (Boehringer Ingelheim's)Genuair first, HandiHaler second |
| group B | Experimental | Device: Genuair® (Almirall S.A.), Device: HandiHaler® (Boehringer Ingelheim's)HandiHaler first, Genuair second |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male or female patients aged ≥ 40 with stable COPD
- Naïve patients to the use of study inhalers
- Patients agreeing on participating and signing the Informed Consent Form
Key exclusion criteria (2 listed)
- Patients with other clinically significant disease, particularly body malformations or diseases affecting coordination and/or motor system
- Patients unable to read product package instructions and answer patient reported questionnaires
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 |
|---|---|---|
| Genuair® (Almirall S.A.)Inhaler with only placebo, once daily, 14 days | Device | group A, group B |
| HandiHaler® (Boehringer Ingelheim's)Inhaler with only placebo, once daily, 14 days | Device | group A, group B |
Primary outcome
Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2
Time frame: 14 days
Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)
2 secondary outcomes
Mean Overall Satisfaction With Genuair and Handihaler at Visit 2
Time frame: 14 days
Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jordi Estruch, Head of GMA study director
Almirall, S.A.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genuair® (Almirall S.A.) and HandiHaler® (Boehringer Ingelheim's) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Almirall, S.A. at 4 sites in 2 countries.
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 3 inclusion and 2 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2015.