Chronic obstructive pulmonary disease Respiratory
Conditions
Interventions
The randomization starts after 14 days of run-in/enrollment phase.
The patients are randomly divided into two groups of 30 each by drawing envelopes containing randomisation numbers. The random num
Sponsors
Erbozeta S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Objective respiratory function (FEV1) measured using spirometry at baseline and after 10 days of treatment 2. Serious adverse events in probable or certain correlation with the correct use of the device, recorded during the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Perceived respiratory function measured using mMRC score (5-point scale) by a questionnaire at baseline and after 10 days of treatment 2. Quality of life measured using CAT score (40-point scale) by a questionnaire at baseline and after 10 days of treatment | — |
Countries
Italy
Contacts
Public ContactGian Carlo Tenore
Outcome results
None listed