Phase 4
N=139
Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients
Chronic Obstructive Pulmonary Disease (COPD)
Bottom Line
View on ClinicalTrials.gov: NCT01727024 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants Who Correctly Used the Device at the Start of Handling the Device — 55; 49 Participants — p=0.451
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tiotropium (Drug); Indacaterol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Correctly Used the Device at the Start of Handling the Device |
55; 49 | 0.451 |
| SECONDARY Number of Participants Correctly Using the Device After One Week of Handling |
93; 81 | — |
| SECONDARY Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire |
46.0; 44.4 | — |
| SECONDARY Number of Participants With Preference for Either Device |
76; 40; 17 | — |
| SECONDARY Number of Participnats With Difficulties Experienced When Handling the Devices |
1; 0; 0; 1; 1; 0 | — |
Summary
This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD
Eligibility Criteria
Key Inclusion Criteria
- Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure.
- Co-operative outpatients with a diagnosis of moderate COPD as classified by the GOLD Guidelines 2010 or grade A in GOLD 2011and including:
- Smoking history of at least 10 pack years
- FEV1/FVC < 70%
Key Exclusion criteria
- Previous diagnosis of asthma
- Pregnant or nursing women
- Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1
Data sourced from ClinicalTrials.gov (NCT01727024). 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.