Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
Preference study: Genuair vs HandiHaler inhalers in COPD patients.
Interventions
DEVICEGenuair® (Almirall S.A.)
Inhaler with only placebo, once daily, 14 days
DEVICEHandiHaler® (Boehringer Ingelheim's)
Inhaler with only placebo, once daily, 14 days
Sponsors
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2 | 14 days | Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Overall Satisfaction With Genuair and Handihaler at Visit 2 | 14 days | 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) |
| Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2 | 14 days | 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. |
Countries
Germany, Netherlands
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Safety Population All patients randomized into the study excluding 1 patient who used Handihaler® once only, Genuair® zero times, & was excluded from the safety population | 129 |
| Total | 129 |
Baseline characteristics
| Characteristic | Overall Study Safety Population |
|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment Germany | 85 participants |
| Region of Enrollment Netherlands | 44 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 63 |
| serious Total, serious adverse events | 0 / 66 | 0 / 63 |
Outcome results
Primary
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)
Time frame: 14 days
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Intention-to-treat Population | Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2 | Prefer Genuair inhaler | 68.6 Percentage of Patients |
| Overall Intention-to-treat Population | Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2 | Prefer Handihaler inhaler | 18.1 Percentage of Patients |
| Overall Intention-to-treat Population | Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2 | No preference | 13.3 Percentage of Patients |
Secondary
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)
Time frame: 14 days
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Overall Intention-to-treat Population | Mean Overall Satisfaction With Genuair and Handihaler at Visit 2 | 4.5655 Units on a scale (1-5) |
| Handihaler Inhaler | Mean Overall Satisfaction With Genuair and Handihaler at Visit 2 | 3.7944 Units on a scale (1-5) |
Secondary
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.
Time frame: 14 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Intention-to-treat Population | Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2 | 10.5 Percentage of Patients |
| Handihaler Inhaler | Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2 | 26.7 Percentage of Patients |