A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Formoterol Fumarate; Pharmaceutical Solutions; Salmeterol Xinafoate

Criteria

Inclusion Criteria

• Subject may be male or female and must be aged less than or equal to 35 years on the day the informed consent is signed.

• Female subjects greater than or equal to 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 (defined as status post-hysterectomy or bilateral tubal ligation) OR

• postmenopausal

• Subject must have a primary diagnosis of COPD, which may include components of chronic bronchitis and/or emphysema. Diagnosis can be made during the screening process.

• Subject must have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years).

• Subject must have a chest x-ray that is consistent with the diagnosis of COPD (e.g., not diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions) and taken less than or equal to 3 months prior to study start. If there is no chest x-ray taken less than or equal to 3 months prior to study start, or if recent results are unavailable for review, a chest x-ray will be performed.

• Subject must be able to complete all study questionnaires and logs reliably. Exclusion Criteria

• Female subject who is pregnant or lactating.

• Subject who has 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.

• Subject who is scheduled for in-patient hospitalization, including elective surgery (in patient or out-patient) during the trial.

• Subject with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to study start.

• Subject with a known history of asthma or any chronic respiratory disease (including a current history of sleep apnea) other than COPD (chronic bronchitis and/or emphysema).

• Subject with a history of cancer except non-melanomatous skin cancer. Subjects with a history of cancer that is considered surgically cured and without a recurrence within the past 10 years may participate in the study. History of hematologic/lymphatic malignancy treated with chemotherapy or radiation is not allowed.

• Subject with a history of lung resection of more than one full lobe.

• Subject who requires continuous supplemental oxygen therapy (unless subject resides at elevation greater than or equal to 4,000 feet).

• Subject who has had a change in dose or type of any medications for COPD within 14 days prior to the screening visit.

• Subject with a known sensitivity to (R,R)-formoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations.

• Subject with a history of substance abuse or drug abuse within 12 months of study start, or with a positive urine drug screen at study start.

• Subject using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers).