Decongestant effect on the respiratory tract of subjects suffering from chronic obstructive pulmonary disease of a sterile class IIb medical device called UNCADEP® AEROSO
Not Applicable
- Conditions
- Chronic obstructive pulmonary diseaseRespiratory
- Registration Number
- ISRCTN58370332
- Lead Sponsor
- Erbozeta S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Caucasian ethnicity
2. Ability to understand the Italian language
3. Age =40 years
4. COPD diagnosed, also by spirometry, for at least 12 months
5. COPD treated pharmacologically and stable for at least 4 weeks
6. COPD associated with expectoration difficulties
Exclusion Criteria
1. Pregnancy and breastfeeding
2. Other kinds of chronic bronchopulmonary diseases, hemoptysis; current or past gastrointestinal ulcers
3. Renal or hepatic insufficiency
4. HIV infection
5. Neoplasms
6. Hypersensitivity to one or more components of the study products
7. Ongoing therapy with other mucoactive agents, antitussives, anticholinergics, or nitroglycerin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Objective respiratory function (FEV1) measured using spirometry at baseline and after 10 days of treatment<br>2. Serious adverse events in probable or certain correlation with the correct use of the device, recorded during the treatment period
- Secondary Outcome Measures
Name Time Method 1. Perceived respiratory function measured using mMRC score (5-point scale) by a questionnaire at baseline and after 10 days of treatment<br>2. Quality of life measured using CAT score (40-point scale) by a questionnaire at baseline and after 10 days of treatment