COPD Clinical Trial
Official title:
A Double-Blind, Double-Dummy, Randomized, Placebo- and Active-Controlled, Multicenter, Parallel-Group Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
Verified date | November 2012 |
Source | Sunovion |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.
Status | Completed |
Enrollment | 717 |
Est. completion date | June 2003 |
Est. primary completion date | June 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sunovion |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent change from study baseline FEV1 to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours post-dose for the QD treatment arm) | Weeks -2, 0, 3, 6, 9, 12 | No | |
Secondary | Time-normalized area under the percent change from visit pre-dose curve for FEV1 over 12 hours (nAUC0-12) | Weeks -2, 0, 3, 6, 9, 12 | No | |
Secondary | Peak percent of predicted FEV1 | Weeks -2, 0, 3, 6, 9, 12 | No | |
Secondary | Time-normalized area under the percent change from study baseline curve for FEV1 over 12 hours (nAUC0-12) | Weeks -2, 0, 3, 6, 9, 12 | Yes | |
Secondary | Time-normalized area under the percent change from study baseline curve for FEV1 over 24 hours (nAUC0-24) | Weeks -2, 0, 3, 6, 9, 12 | No | |
Secondary | Timepoint changes in FEV1 | Weeks -2, 0, 3, 6, 9, 12 | No | |
Secondary | Time to onset of response | Weeks -2, 0, 3, 6, 9, 12 | No | |
Secondary | Time to peak change in FEV1 | Weeks -2, 0, 3, 6, 9, 12 | No | |
Secondary | At-home and in-clinic peak expiratory flow rate (PEFR) | Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | No | |
Secondary | Ipratropium bromide MDI use | Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | Yes | |
Secondary | Racemic albuterol MDI use | Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | Yes | |
Secondary | Exacerbations of COPD | Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | Yes | |
Secondary | COPD symptom ratings (over 12 weeks of treatment) | Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | No | |
Secondary | Relationship between plasma concentrations of (R,R) formoterol and selected pharmacodynamic parameters | Weeks -2, 0, 3, 6, 9, 12 | No |
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