Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT01351792
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative.
2. Outpatients with a clinical diagnosis of moderate to severe COPD and including:
1. Smoking history of at least 10 pack years defined as \[(number of cigarettes smoked per day) x (number of years of smoking)\] / 20, both current and ex-smokers are eligible.
2. Regular use of bronchodilators (e.g. β2-agonist, anticholinergics) in the 2 months before visit 1.
3. Post-bronchodilator FEV1 \< 65% of the predicted normal value at visit 1.
4. Post-bronchodilator FEV1/FVC \< 0.7 at visit 1.
5. An increase in FEV1 \< 15% and \< 200 mL from baseline following administration of 400 µg of salbutamol at visit 1.
6. Plethysmographic Functional Residual Capacity (FRC) \> 120% of the predicted normal value (at visit 1 and visit 2).
7. A Baseline Dyspnoea Index (BDI) focal score less or equal to 10 (at visit 1 and at visit 2).
3. A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Turbohaler®, inspiratory flow-driven, multidose powder inhaler) inhalers.
Main Exclusion Criteria:
1. Diagnosis of asthma or other clinically or functionally relevant respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator's opinion.
2. Clinically unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which may impact the evaluation of the results of the study according to investigator's judgement.
3. Patients with COPD exacerbation and/or symptomatic infection of the airways requiring antibiotic therapy (at least 5 days) in the 2 months prior to screening and during the study period.
4. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
5. Major surgery in the previous 3 months and during the trial which may affect patient's compliance in study procedures (e.g. plethysmography).
6. Patients requiring chronic mechanical ventilation for COPD.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01351792
Study Brief:
Protocol Section:
NCT01351792