Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD - Full Text View

Purpose

The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema	Drug: arformoterol tartrate inhalation solution Drug: Salmeterol Drug: Placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Chronic Bronchitis Emphysema

Drug Information available for: Formoterol fumarate Formoterol Salmeterol Salmeterol xinafoate Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

percent change in trough FEV1 from study baseline to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours postdose for the QD treatment arm) over the double-blind period. [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time-normalized area under the percent change from visit predose curve for FEV1 over 12 hours (nAUC0-12-P) [ 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 in FEV1 from study baseline over 12 hours (nAUC0-12-B) [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ]
time-normalized area under the percent change from visit predose curve for FEV1 over 24 hours (nAUC0-24-P) [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ]
time-normalized area under the percent change in FEV1 from study baseline curve over 24 hours (nAUC0-24-B) [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ]
peak percent change in FEV1 from visit predose and study baseline [ Time Frame: Weeks -2, 0, 3, 6, 9, 12 ] [ Designated as safety issue: No ]
time point changes in FEV1; 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, 3, 6, 9, 12 ] [ Designated as safety issue: No ]
relationship between the plasma concentration values and selected pharmacodynamic parameters [ Time Frame: Weeks -2, 0, 3, 6, 9, 12, 13 ] [ Designated as safety issue: No ]
Supplemental ipratropium bromide MDI and racemic albuterol MDI use [ Time Frame: Weeks 0-13 ] [ Designated as safety issue: No ]
COPD exacerbations and COPD symptom ratings [ Time Frame: Weeks 0-13 ] [ Designated as safety issue: Yes ]
St. George's Hospital Respiratory Questionnaire [ Time Frame: Weeks 0, 6, 13 ] [ Designated as safety issue: Yes ]
Investigator and Subject Global Evaluations [ Time Frame: Weeks -2, 12, 13 ] [ Designated as safety issue: Yes ]
Baseline and Transitional Dyspnea Index [ Time Frame: Weeks -2, 6, 12 ] [ Designated as safety issue: Yes ]
distance walked in six minutes [ Time Frame: Weeks -2, 3, 9 ] [ Designated as safety issue: Yes ]

Enrollment:	741
Study Start Date:	April 2002
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Arformoterol 50 mcg QD and placebo MDI	Drug: arformoterol tartrate inhalation solution arformoterol 50 mcg QD Other Name: (R,R)-formoterol
Experimental: 2 Arformoterol 25 mcg BID and Placebo MDI	Drug: arformoterol tartrate inhalation solution arformoterol 25 mcg BID Other Name: (R,R)-formoterol
Experimental: 3 Arformoterol 15 mcg BID and placebo MDI	Drug: arformoterol tartrate inhalation solution arformoterol 15 mcg BID Other Names: (R,R)-formoterol Brovana
Active Comparator: 4 Salmeterol MDI 42 mcg BID and placebo inhalation solution	Drug: Salmeterol Salmeterol MDI 42 mcg BID Other Name: Serevent MDI
Placebo Comparator: 5 Placebo MDI and placebo inhalation solution	Drug: Placebo Placebo BID

Detailed Description:

This was a double-blind, double-dummy, randomized, placebo- and active-controlled, multicenter, parallel-group study of adult subjects with COPD. The study was double blinded through the use of both unit dose vial (UDV) and metered-dose inhaler (MDI) placebos, as appropriate. The primary efficacy analysis utilized the placebo control. Secondary analyses of the primary efficacy endpoint utilized the active control, and included comparisons between the placebo and active control. 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.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064402

Show 65 Study Locations

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00064402 History of Changes
Other Study ID Numbers:	091-051
Study First Received:	July 8, 2003
Last Updated:	February 21, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes
Formoterol
Salmeterol

Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013