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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00064402
Eligibility Criteria:
Inclusion Criteria:
* Be willing to comply with study procedures and visit schedule
* Are at least 35 years of age
* Female subjects \>65 years of age must have a serum pregnancy test conducted at Visit 1 and confirmed negative prior to randomization
* Subjects of childbearing potential must be using an acceptable method of birth control. Female subjects who are considered not of childbearing potential must be: documented surgically sterile, OR postmenopausal.
* Have a primary diagnosis of COPD. Diagnosis can be made during the screening process.
* Have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years).
* Have a chest x-ray that is consistent with the diagnosis of COPD and taken \<3 months prior to study start
* Able to complete all study questionnaires and logs reliably
Exclusion Criteria:
* Female subject who is pregnant or lactating
* Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another investigational drug study
* Subject whose schedule or travel prevents the completion of all required visits
* Are scheduled for in-patient hospitalization, including elective surgery during the trial
* Have life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days
* History of asthma or any chronic respiratory disease other than COPD (chronic bronchitis and/or emphysema)
* Have clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
* Have a history of cancer except non-melanomatous skin cancer
* Have a history of lung resection of more than one full lobe
* Requires continuous supplemental oxygen therapy.
* Has had a change in dose or type of any medications for COPD within 14 days prior to the screening visit
* Have a known sensitivity to arformoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations
* Have a history of substance abuse or drug abuse within 12 months, or with a positive urine drug screen
* Are using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT00064402
Study Brief:
Protocol Section:
NCT00064402