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:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT00116402
Eligibility Criteria:
Inclusion Criteria:
* Males or females \> 50 years of age
* Physiologic evidence of COPD defined per ATS guidelines as: cigarette smoking history \>20 pack years, FEV1/FVC \<70%
* Patients must have a post-bronchodilator FEV1 \>50% of predicted value at enrollment
* Patient must have an O2 saturation measure by pulse oximetry \>90% on RA
* Must be able to participate in the study, willing to give informed consent, and comply with the study restrictions
Exclusion Criteria:
* Women of child-bearing potential defined as females who are less than 5 years post menopausal unless they have had a hysterectomy or bilateral oophorectomy
* Observation of any solitary nodule in the lung requiring further medical intervention
* Patients on maintenance therapy with oral steroids
* Patients with giant bullous disease
* Significant other medical conditions, which in the opinion of the investigator, will interfere with the patient's ability to perform the study tests
* Presence of a coagulopathy as defined by a platelet count \<100,000/mm3, and PT and PTT \>1.2 x the upper limit of normal
* Concurrent enrollment or participation in any other clinical trials within the past 30 days
* Primary diagnosis of asthma
* History of alpha 1 antitrypsin deficiency
* Any clinically significant and active pulmonary disease that could contribute to dyspnea
* Current systemic and inhaled steroids and theophylline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00116402
Study Brief:
Protocol Section:
NCT00116402