Trial Outcomes & Findings for Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients (NCT NCT01385696)
NCT ID: NCT01385696
Last Updated: 2015-06-24
Results Overview
Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)
COMPLETED
PHASE3
130 participants
14 days
2015-06-24
Participant Flow
This study was conducted 4 centres, 2 in The Netherlands and 2 in Germany. The first patient was screened in June 2011 and the last patient visit was in January 2012.
Participant milestones
| Measure |
Placebo Genuair (Daily) Then Placebo HandiHaler (Daily)
Each morning, patients used the Genuair® (Almirall S.A.) inhaler containing placebo followed by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo. The study period consisted of 1 period of 14 days.
|
Placebo HandiHaler (Daily) Then Placebo Genuair (Daily)
Each morning, patients used the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo followed by the Genuair® (Almirall S.A.) inhaler containing placebo. The study period consisted of 1 period of 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
64
|
|
Overall Study
COMPLETED
|
66
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients
Baseline characteristics by cohort
| Measure |
Overall Study Safety Population
n=129 Participants
All patients randomized into the study excluding 1 patient who used Handihaler® once only, Genuair® zero times, \& was excluded from the safety population
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|---|---|
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Age, Continuous
|
65.9 years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
|
Sex: Female, Male
Female
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42 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
85 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
44 participants
n=93 Participants
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PRIMARY outcome
Timeframe: 14 daysPopulation: ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data was handled via the observed cases approach.
Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)
Outcome measures
| Measure |
Overall Intention-to-treat Population
n=105 Participants
Overall intention-to-treat (ITT) population
|
Handihaler Inhaler
Intention-to-treat (ITT) population
|
|---|---|---|
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Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2
Prefer Genuair inhaler
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68.6 Percentage of Patients
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—
|
|
Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2
Prefer Handihaler inhaler
|
18.1 Percentage of Patients
|
—
|
|
Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2
No preference
|
13.3 Percentage of Patients
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.
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)
Outcome measures
| Measure |
Overall Intention-to-treat Population
n=104 Participants
Overall intention-to-treat (ITT) population
|
Handihaler Inhaler
n=105 Participants
Intention-to-treat (ITT) population
|
|---|---|---|
|
Mean Overall Satisfaction With Genuair and Handihaler at Visit 2
|
4.5655 Units on a scale (1-5)
Interval 4.3132 to 4.8177
|
3.7944 Units on a scale (1-5)
Interval 3.5425 to 4.0462
|
SECONDARY outcome
Timeframe: 14 daysPopulation: ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.
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.
Outcome measures
| Measure |
Overall Intention-to-treat Population
n=104 Participants
Overall intention-to-treat (ITT) population
|
Handihaler Inhaler
n=105 Participants
Intention-to-treat (ITT) population
|
|---|---|---|
|
Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2
|
10.5 Percentage of Patients
|
26.7 Percentage of Patients
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Adverse Events
Genuair Then HandiHaler
HandiHaler Then Genuair
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Project Leader and Trial Manager
Almirall S.A.
Results disclosure agreements
- Principal investigator is a sponsor employee All the information related to this clinical trial is considered strictly confidential and is the property of Almirall. This information will not be given to a third party without the written consent of Almirall. Publication and/or presentation, whether complete or partial, of any part of the data or results of this trial will be subject to revision and written agreement between the investigator and Almirall.
- Publication restrictions are in place
Restriction type: OTHER