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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sunovion

ClinicalTrials.gov Identifier:

NCT00685841

First received: May 23, 2008

Last updated: November 1, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 23, 2008
Last Updated Date	November 1, 2012
Start Date ^ICMJE	February 2002
Primary Completion Date	June 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 27, 2008)	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) [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00685841 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 27, 2008)	Time-normalized area under the percent change from visit pre-dose curve for FEV1 over 12 hours (nAUC0-12) [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ] Peak percent of predicted FEV1 [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ] Time-normalized area under the percent change from study baseline curve for FEV1 over 12 hours (nAUC0-12) [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: Yes ] Time-normalized area under the percent change from study baseline curve for FEV1 over 24 hours (nAUC0-24) [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ] Timepoint changes in FEV1 [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ] Time to onset of response [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ] Time to peak change in FEV1 [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ] At-home and in-clinic peak expiratory flow rate (PEFR) [ Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: No ] Ipratropium bromide MDI use [ Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: Yes ] Racemic albuterol MDI use [ Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: Yes ] Exacerbations of COPD [ Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: Yes ] COPD symptom ratings (over 12 weeks of treatment) [ Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: No ] Relationship between plasma concentrations of (R,R) formoterol and selected pharmacodynamic parameters [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Official Title ^ICMJE	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
Brief Summary	A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.
Detailed 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	COPD
Intervention ^ICMJE	Drug: Arformoterol tartrate inhalation solution Arformoterol 50 mcg QD Other Names: (R,R-)formoterol Brovana Drug: Arformoterol tartrate inhalation solution Arformoterol 25 mcg BID Other Names: (R,R)-formoterol Brovana Drug: Arformoterol tartrate inhalation solution Arformoterol 15 mcg BID Other Names: (R,R)-formoterol Brovana Drug: Salmeterol MDI Salmeterol MDI 42 mcg BID Other Name: Serevent Drug: Placebo Placebo BID MDI
Study Arm (s)	Experimental: A Arformoterol 50 mcg QD and placebo MDI Intervention: Drug: Arformoterol tartrate inhalation solution Experimental: B Arformoterol 25 mcg BID and placebo MDI Intervention: Drug: Arformoterol tartrate inhalation solution Experimental: C Arformoterol 15 mcg BID and placebo MDI Intervention: Drug: Arformoterol tartrate inhalation solution Active Comparator: D Salmeterol MDI 42 mcg BID and placebo inhalation solution Intervention: Drug: Salmeterol MDI Placebo Comparator: E Placebo BID MDI and inhalation solution Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	717
Completion Date	June 2003
Primary Completion Date	June 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	35 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00685841
Other Study ID Numbers ^ICMJE	091-050
Has Data Monitoring Committee	Yes
Responsible Party	Sunovion
Study Sponsor ^ICMJE	Sunovion
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sunovion
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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