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COPDPhase 2NCT00691405

A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing Arformoterol tartrate inhalation solution in people with COPD, run by Sumitomo Pharma America, Inc. at 31 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol (given once or twice a day) 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
215 participants
Where
31 sitesUnited States
Study dates
Oct 2003to May 2004
Phase
Phase 2
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 greater than or equal to 35 years on the day the informed consent is signed.
  • Female subject less than or equal to 65 years of age must have a serum pregnancy test conducted at study start and confirmed negative. Subjects of childbearing potential must be using an acceptable method of birth control and agree to continue its use throughout the study.
  • In order to be considered not of childbearing potential female subjects 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.
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  • 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) and taken less than or equal to 6 months before study start. If there is no chest x-ray taken less than or equal to 6 months before study start, a chest x-ray will be performed at Visit 1.
  • Subject must be able to complete all study questionnaires and logs reliably.

Who cannot join

  • A female 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's schedule or travel prevents the completion of all required visits.
  • Subject is scheduled for in-patient hospitalization, including elective surgery (in patient or out-patient) during the trial.
  • Subject has had a life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the 30 days prior to study start.
  • Subject has a known history of asthma (except childhood asthma) or any chronic respiratory disease (including a current history of sleep apnea) other than COPD (chronic bronchitis and/or emphysema).
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  • Subject has a known history of alpha 1 antitrypsin deficiency-related emphysema.
  • Subject has a history of cancer except non-melanoma skin cancer. Subjects with a history of cancer that is considered surgically cured and without a recurrence within the past 5 years may participate in the study. History of hematologic/lymphatic malignancy treated with chemotherapy or radiation is not allowed, under any condition.
  • Subject has a history of lung resection of more than one full lobe or being a recipient of a lung or major organ transplant.
  • Subject requires continuous supplemental oxygen therapy (unless subject resides at elevation greater than or equal to 4,000 feet).
  • Subject has had a change in dose or type of any medications for COPD within 14 days before the screening visit.
  • Subject has a known sensitivity to arformoterol, ipratropium or albuterol or any of the excipients contained in any of these formulations.
  • Subject has a history of substance abuse within 12 months of Visit 1, or with a positive urine drug screen at study start.
  • Subject is using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers).
  • Subject has had significant blood loss (>500 cc) or donated blood within 60 days preceding screening or plans to donate blood during or within 60 days after completing the study.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Study site

    Austell, Georgia

  • Study site

    Austin, Texas

  • Study site

    Brandon, Florida

  • Study site

    Charleston, South Carolina

  • Study site

    Cleawater, Florida

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Encinitas, California

  • Study site

    Eugene, Oregon

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Hickory, North Carolina

  • Study site

    Jacksonville, Florida

  • Study site

    Long Beach, California

  • Study site

    Marrero, Louisiana

  • Study site

    McCook, Nebraska

  • Study site

    Medford, Oregon

  • Study site

    New Orleans, Louisiana

  • Study site

    Opelousas, Louisiana

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Port Orange, Florida

  • Study site

    Princeton, New Jersey

  • Study site

    Renton, Washington

  • Study site

    San Antonio, Texas

  • Study site

    Simpsonville, South Carolina

  • Study site

    Spartanburg, South Carolina

  • Study site

    Spokane, Washington

  • Study site

    Statesville, North Carolina

  • Study site

    Tacoma, Washington

  • Study site

    Topeka, Kansas

  • Study site

    West Palm Beach, Florida

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Multicenter, Two-part Parallel-group, Dose-ranging Study of Twice-daily and Once-daily (R,R) Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol (given once or twice a day) in subjects with COPD.

Read the detailed description

This study is a double-blind, repeat-dose, randomized, multicenter, two-part, parallel-group, dose-ranging study of arformoterol and placebo in the treatment of subjects with COPD. Approximately 215 subjects will be randomized in this study. Study participation will consist of a total of eight (8) study visits over approximately ten (10) weeks 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, Placebo
Keywords
Arformoterol, (R,R)-formoterol
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 5 mcg BID

  • Arformoterol tartrate inhalation solutionDrug

    Also called (R,R)-formoterol, Brovana

    Arformoterol 15 mcg BID

  • Arformoterol tartrate inhalation solutionDrug

    Also called (R,R)-formoterol, Brovana

    Arformoterol 25 mcg BID

  • PlaceboDrug

    Placebo inhalation solution BID

  • Arformoterol tartrate inhalation solutionDrug

    Also called (R,R)-formoterol, Brovana

    Arformoterol 15 mcg QD

  • Arformoterol tartrate inhalation solutionDrug

    Also called (R,R)-formoterol, Brovana

    Arformoterol 25 mcg QD

  • Arformoterol tartrate inhalation solutionDrug

    Also called (R,R)-formoterol, Brovana

    Arformoterol 50 mcg QD

  • PlaceboDrug

    Placebo inhalation solution QD

Study groups in NCT00691405
Study groupRoleWhat they receive
A1ExperimentalArformoterol 5 mcg BID for 14 days
Receives: Drug: Arformoterol tartrate inhalation solution
A2ExperimentalArformoterol 15 mcg BID for 14 days
Receives: Drug: Arformoterol tartrate inhalation solution
A3ExperimentalArformoterol 25 mcg BID for 14 days
Receives: Drug: Arformoterol tartrate inhalation solution
A4Placebo comparatorPlacebo inhalation solution BID for 14 days
Receives: Drug: Placebo
B1ExperimentalArformoterol 15 mcg QD for 14 days
Receives: Drug: Arformoterol tartrate inhalation solution
B2ExperimentalArformoterol 25 mcg QD for 14 days
Receives: Drug: Arformoterol tartrate inhalation solution
B3ExperimentalArformoterol 50 mcg QD for 14 days
Receives: Drug: Arformoterol tartrate inhalation solution
B4Placebo comparatorPlacebo inhalation solution QD for 14 days
Receives: Drug: Placebo

What is being measured

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

  1. Part A: The primary efficacy endpoint is the time-normalized area under the FEV1 percent change from pre-dose curve over 12 hours (nAUC0-12) after the first (AM) dose at the 24 hour clinic visit (Visit 4) following 14 days of double-blind treatment.

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  2. Part B: The primary efficacy endpoint is the time-normalized area under the FEV1 percent change from pre-dose curve over 24 hours (nAUC0-24) at the 24 hour clinic visit (Visit 7) following 14 days of double-blind treatment.

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

Secondary outcomes (13)

  1. Relationship between plasma concentrations of arformoterol and changes in ECG QTc intervals at steady state throughout the dosing interval.

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  2. Part A only: Time-normalized area under the curve for FEV1 percent change from pre-dose over 24 hours (nAUC0-24) for each 24 hour clinic visit.

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14),

  3. Part B only: Time-normalized area under curve for the FEV1 percent change from pre-dose over 12 hours (nAUC0-12) for each 24 hour clinic visit.

    Measured: Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  4. Time-normalized area under the curve for the percent change in FEV1 from pre-dose over 6 hours (nAUC0-6) for the 6 hour clinic visit (Visits 3 and 6).

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  5. Percent change in FEV1 from pre-dose to each post dose time point

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  6. Peak percent change in FEV1 post-dose

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  7. Ipratropium bromide metered-dose inhaler (MDI) use and racemic albuterol MDI use

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  8. Morning and evening peak expiratory flow rate (PEFR)

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  9. Exacerbations of COPD

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  10. COPD symptom ratings

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  11. Effects of withdrawal from therapy

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

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

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

  13. FEV1 percent change from pre-dose (24-hour trough) following 14 days of double-blind treatment.

    Measured: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)

Timeline

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

  1. First posted5 Jun 2008 (estimated)
  2. Study startOct 2003
  3. Primary completionMay 2004
  4. Study completionMay 2004

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00691405
Sponsor's protocol ID
091-026
Status last verified
Feb 2012
First submitted
2 Jun 2008
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arformoterol tartrate inhalation solution in people with COPD, run by Sumitomo Pharma America, Inc. at 31 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 9 inclusion and 15 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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Part A: The primary efficacy endpoint is the time-normalized area under the FEV1 percent change from pre-dose curve over 12 hours (nAUC0-12) after the first (AM) dose at the 24 hour clinic visit (Visit 4) following 14 days of double-blind treatment. (time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)). The study lists 2 primary outcomes in all. 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 NCT00691405.

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 22 Feb 2012.

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