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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685841
• Other study ID #: 091-050
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2008
• Last updated: November 1, 2012
• Start date: February 2002
• Est. completion date: June 2003

Study information

• Verified date: November 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study is a double-blind, double-dummy, randomized, placebo- and active-controlled, multicenter, parallel-group study of adult subjects with a primary clinical diagnosis of COPD. Approximately 800 subjects were to be randomized in this study. Study participation consisted of a total of eight (8) study visits over approximately four (4) months for each subject. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Recruitment information / eligibility

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Arformoterol tartrate inhalation solution
Arformoterol 50 mcg QD
• Arformoterol tartrate inhalation solution
Arformoterol 25 mcg BID
• Arformoterol tartrate inhalation solution
Arformoterol 15 mcg BID
• Salmeterol MDI
Salmeterol MDI 42 mcg BID
• Placebo
Placebo BID MDI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

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