Chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease
Conditions
Interventions
Pulmonary function test (PFT) and impulse oscillometry (IOS) are performed at baseline before and during dose-response curve (DRC) to salbutamol (100 µg, 200 µg, 400 µg, 800 µg). After that, patients
Sponsors
University of Rome Tor Vergata
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. COPD patients =40 years old 2. Current or former smokers, with a cigarette smoking history of =10 pack-years 3. Confirmed diagnosis of COPD (FEV1/forced vital capacity (FVC) <0.7) FEV1 <65% predicted, history of =1 severe exacerbation of COPD in the last year
Exclusion criteria
Exclusion criteria: 1. Patients with history of asthma 2. Reversibility of FEV1 by >200 ml and/or >12% after inhalation of 200 µg salbutamol 3. Under treatment with ICS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bronchorelaxant effect at the level of small airways (airway resistance) measured using impulse oscillometry at baseline (day 1), day 14 and day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bronchorelaxant effect at the level of medium bronchi measured using forced expiratory volume in 1 s [FEV1] at baseline (day 1), day 14 and day 15 2. Dyspnea using Modified British Medical Research Council Questionnaire ( mMRC) and Visual Analogue Scale (VAS) at baseline (day 1), day 14 and day 15 3. Oxygen saturation (SpO2) and heart rate (HR) using pulse oximetry at baseline (day 1), day 14 and day 15 | — |
Countries
Italy
Outcome results
None listed