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

NCT00685841 | Completed Phase 3 DMC

• 1 other identifier: 091-050
• Study Type: interventional
• Target: 717
• Locations: 1 country
• Sites: 52

Brief Summary

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

Conditions

COPD

Keywords

Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• 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

• Peak percent of predicted FEV1

  Weeks -2, 0, 3, 6, 9, 12

• 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

• 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

• Timepoint changes in FEV1

  Weeks -2, 0, 3, 6, 9, 12

Study Arms (5)

A

EXPERIMENTAL

Arformoterol 50 mcg QD and placebo MDI

Drug: Arformoterol tartrate inhalation solution

B

EXPERIMENTAL

Arformoterol 25 mcg BID and placebo MDI

Drug: Arformoterol tartrate inhalation solution

C

EXPERIMENTAL

Arformoterol 15 mcg BID and placebo MDI

Drug: Arformoterol tartrate inhalation solution

D

ACTIVE COMPARATOR

Salmeterol MDI 42 mcg BID and placebo inhalation solution

Drug: Salmeterol MDI

E

PLACEBO COMPARATOR

Placebo BID MDI and inhalation solution

Drug: Placebo

Interventions

Arformoterol tartrate inhalation solution DRUG

Arformoterol 50 mcg QD

Also known as: (R,R-)formoterol, Brovana

A

Salmeterol MDI DRUG

Salmeterol MDI 42 mcg BID

Also known as: Serevent

D

Placebo DRUG

Placebo BID MDI

E

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (52)

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Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Jasper, Alabama, United States

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Mobile, Alabama, United States

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Oxford, Alabama, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Mirage, California, United States

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Mission Hills, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Signal Hill, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Pensacola, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Austell, Georgia, United States

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Decatur, Georgia, United States

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Bloomington, Illinois, United States

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Evansville, Indiana, United States

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Shawnee Mission, Kansas, United States

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Minneapolis, Minnesota, United States

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Charles, Missouri, United States

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Las Vegas, Nevada, United States

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Margate City, New Jersey, United States

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South Bound Brook, New Jersey, United States

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Albuquerque, New Mexico, United States

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Endwell, New York, United States

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Ithaca, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Spartanburg, North Carolina, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Houston, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Chesapeake, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Albuterol; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: February 1, 2002
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: November 2, 2012

Record last verified: 2012-11

Locations

US (52)