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 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT01168895
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects with COPD, 40 - 75 years of age
* All subjects must have a diagnosis of COPD and must have airway obstruction with a post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of \>/= 30% and \<= 80% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of \</= 70%
* Subjects must be current or ex-smokers with a smoking history of more than 10 pack-years
* Subjects must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol
* Subjects must be able to produce an sufficient amount of sputum during sputum induction at screening
Exclusion Criteria:
* Subjects with a significant respiratory disease other than COPD.
* Exacerbation within 8 weeks prior to screening
* Subjects with more than 1 COPD exacerbation within 12 months prior to screening
* Subjects must have an FEV1 of at least one Liter
* Subjects with a history or physician's diagnosis of asthma. If a patient has a total blood eosinophil count \>/= 0.6 x 10\^9/L source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
* Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to inactive constituents of the inhalation powder
* Subjects with known hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
* Subjects with a history of cystic fibrosis
* Subjects with clinically evident bronchiectasis
* Subjects taking any:
* Oral beta-adrenergic drugs or non cardioselective beta blockers,
* Oral glucocorticoids,
* Antihistamines or antileukotrienes prescribed for asthma,
* Oral cromolyn sodium or oral nedocromil sodium,
* Concomitant inhalative therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01168895
Study Brief:
Protocol Section:
NCT01168895