Phase 3
N=130
Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients
Chronic Obstructive Pulmonary Disease (COPD)
Bottom Line
View on ClinicalTrials.gov: NCT01385696 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2 — 68.6; 18.1; 13.3 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Genuair® (Almirall S.A.) (Device); HandiHaler® (Boehringer Ingelheim's) (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Almirall, S.A.
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2 |
68.6; 18.1; 13.3 | — |
| SECONDARY Mean Overall Satisfaction With Genuair and Handihaler at Visit 2 |
4.5655; 3.7944 | — |
| SECONDARY Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2 |
10.5; 26.7 | — |
Summary
Preference study: Genuair vs HandiHaler inhalers in COPD patients.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01385696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.