Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— INHALATOROfficial title:
Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease
Verified date | January 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD
Status | Completed |
Enrollment | 140 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Key Inclusion Criteria: 1. Male and female adults aged =40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure. 2. 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: 1. Previous diagnosis of asthma 2. Pregnant or nursing women 3. Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1 |
Country | Name | City | State |
---|---|---|---|
Brazil | Novartis Investigative Site | Belo Horizonte | MG |
Brazil | Novartis Investigative Site | Belo Horizonte | MG |
Brazil | Novartis Investigative Site | Florianopolis | SC |
Brazil | Novartis Investigative Site | Goiania | GO |
Brazil | Novartis Investigative Site | Porto Alegre | RS |
Brazil | Novartis Investigative Site | Porto Alegre | RS |
Brazil | Novartis Investigative Site | Ribeirao Preto | SP |
Brazil | Novartis Investigative Site | Rio de Janeiro | RJ |
Brazil | Novartis Investigative Site | Sao Paulo | SP |
Brazil | Novartis Investigative Site | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Correctly Used the Device at the Start of Handling the Device | The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices. | day 1 | |
Secondary | Number of Participants Correctly Using the Device After One Week of Handling | The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices. | day 7 | |
Secondary | Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire | Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices. The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction |
day 7 | |
Secondary | Number of Participants With Preference for Either Device | Participants answered a single question to determine their device preference. | day 7 | |
Secondary | Number of Participnats With Difficulties Experienced When Handling the Devices | Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed. | 1 week |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03282019 -
Study of Long-term HFNC for COPD Patients With HOT
|
N/A | |
Completed |
NCT05573464 -
A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
|
Phase 3 | |
Recruiting |
NCT06040086 -
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
|
Phase 3 | |
Not yet recruiting |
NCT06376994 -
Multi-Center Clean Air Randomized Controlled Trial in COPD
|
Phase 3 | |
Completed |
NCT02797392 -
Feasibility of a Preventive Program Against Lifestyle Related Diseases
|
N/A | |
Completed |
NCT02926534 -
Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan
|
N/A | |
Completed |
NCT02728674 -
Management of Patients With Respiratory Symptoms in Sweden
|
N/A | |
Recruiting |
NCT02415478 -
Bronchioscopic Lung Volume Reduction (BLVR)
|
N/A | |
Completed |
NCT02774226 -
Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02512510 -
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT02518139 -
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT03487406 -
Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2)
|
Phase 2 | |
Completed |
NCT02459080 -
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT01893476 -
A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management
|
N/A | |
Completed |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
Withdrawn |
NCT01908933 -
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
|
Phase 3 | |
Completed |
NCT01908140 -
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT01701869 -
Microbiology & Immunology of the Chronically-inflamed Airway
|
N/A | |
Recruiting |
NCT02527486 -
Seoul National University Airway Registry
|
N/A | |
Withdrawn |
NCT01377428 -
Efficacy of Indacaterol 150 µg Versus Formoterol
|
Phase 4 |