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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT01040728
Eligibility Criteria:
Inclusion criteria:
* Patients willing to participate with confirmed diagnosis of COPD
* 40 years of age or older
* having a 10 pack year smoking history
* able to perform serial pulmonary function tests
* able to use both a Dry powder inhaler (DPI) and Respimat device
Exclusion criteria:
* Significant other disease
* clinically relevant abnormal hematology, chemistry, or urinalysis
* history of asthma
* diagnosis of thyrotoxicosis
* paroxysmal tachycardia related to beta agonists
* history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
* active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
* significant alcohol or drug abuse
* pulmonary resection
* taking oral beta adrenergics
* taking unstable oral steroids
* daytime oxygen
* enrolled in rehabilitation program
* enrolled in another study or taking investigational products
* pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
* those who are not willing to comply with pulmonary medication washouts
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01040728
Study Brief:
Protocol Section:
NCT01040728