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COPDPhase 3NCT00685841

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

A Phase 3 study testing Arformoterol tartrate inhalation solution and Salmeterol MDI in people with COPD, run by Sumitomo Pharma America, Inc. at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 35 years and older
Conditions the study is for
COPD
What is being tested?
Arformoterol tartrate inhalation solution and Salmeterol MDI
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
717 participants
Where
52 sitesUnited States
Study dates
Feb 2002to Jun 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 22Show fewer
  • 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).

Who cannot join

None listed.

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anniston, Alabama

  • Study site

    Atlanta, Georgia

  • Study site

    Austell, Georgia

  • Study site

    Birmingham, Alabama

  • Study site

    Bloomington, Illinois

  • Study site

    Charles, Missouri

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chesapeake, Virginia

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Colorado Springs, Colorado

  • Study site

    Decatur, Georgia

  • Study site

    DeLand, Florida

  • Study site

    Denver, Colorado

  • Study site

    Endwell, New York

  • Study site

    Evansville, Indiana

  • Study site

    Houston, Texas

  • Study site

    Irving, Texas

  • Study site

    Ithaca, New York

  • Study site

    Jasper, Alabama

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Margate City, New Jersey

  • Study site

    Medford, Oregon

  • Study site

    Miami, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mirage, California

  • Study site

    Mission Hills, California

  • Study site

    Mobile, Alabama

  • Study site

    New York, New York

  • Study site

    Ocala, Florida

  • Study site

    Oxford, Alabama

  • Study site

    Pensacola, Florida

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Ana, California

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Signal Hill, California

  • Study site

    South Bound Brook, New Jersey

  • Study site

    Spartanburg, North Carolina

  • Study site

    St. Petersburg, Florida

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Tulsa, Oklahoma

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Wilmington, North Carolina

Other trials in United States

About this study

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

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

Read the 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.

Conditions
COPD
Being tested
Arformoterol tartrate inhalation solution, Salmeterol MDI, Placebo
Keywords
Chronic obstructive pulmonary disease
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arformoterol tartrate inhalation solutionDrug

    Also called (R,R-)formoterol, Brovana

    Arformoterol 50 mcg QD

  • Arformoterol tartrate inhalation solutionDrug

    Also called (R,R)-formoterol, Brovana

    Arformoterol 25 mcg BID

  • Arformoterol tartrate inhalation solutionDrug

    Also called (R,R)-formoterol, Brovana

    Arformoterol 15 mcg BID

  • Salmeterol MDIDrug

    Also called Serevent

    Salmeterol MDI 42 mcg BID

  • PlaceboDrug

    Placebo BID MDI

Study groups in NCT00685841
Study groupRoleWhat they receive
AExperimentalArformoterol 50 mcg QD and placebo MDI
Receives: Drug: Arformoterol tartrate inhalation solution
BExperimentalArformoterol 25 mcg BID and placebo MDI
Receives: Drug: Arformoterol tartrate inhalation solution
CExperimentalArformoterol 15 mcg BID and placebo MDI
Receives: Drug: Arformoterol tartrate inhalation solution
DActive comparatorSalmeterol MDI 42 mcg BID and placebo inhalation solution
Receives: Drug: Salmeterol MDI
EPlacebo comparatorPlacebo BID MDI and inhalation solution
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (13)

  1. Time-normalized area under the percent change from visit pre-dose curve for FEV1 over 12 hours (nAUC0-12)

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

  2. Peak percent of predicted FEV1

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

  3. Time-normalized area under the percent change from study baseline curve for FEV1 over 12 hours (nAUC0-12)

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

  4. Time-normalized area under the percent change from study baseline curve for FEV1 over 24 hours (nAUC0-24)

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

  5. Timepoint changes in FEV1

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

  6. Time to onset of response

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

  7. Time to peak change in FEV1

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

  8. At-home and in-clinic peak expiratory flow rate (PEFR)

    Measured: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  9. Ipratropium bromide MDI use

    Measured: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  10. Racemic albuterol MDI use

    Measured: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  11. Exacerbations of COPD

    Measured: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  12. COPD symptom ratings (over 12 weeks of treatment)

    Measured: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  13. Relationship between plasma concentrations of (R,R) formoterol and selected pharmacodynamic parameters

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2008 (estimated)
  2. Study startFeb 2002
  3. Primary completionJun 2003
  4. Study completionJun 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
717 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00685841
Sponsor's protocol ID
091-050
Status last verified
Nov 2012
First submitted
23 May 2008
Last updated
2 Nov 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Arformoterol tartrate inhalation solution and Salmeterol MDI in people with COPD, run by Sumitomo Pharma America, Inc. at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00685841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2012.

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