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CompletedNCT00691405Updated Feb 22, 2012

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 interventional study of Arformoterol tartrate inhalation solution and Arformoterol tartrate inhalation solution in COPD, sponsored by Sumitomo Pharma America, Inc.. Completed at 31 sites in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Sumitomo Pharma America, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
215
Allocation
Randomized
Ages
35 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • COPD

Keywords

  • Arformoterol
  • (R,R)-formoterol
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 215 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
215 participants (actual)

Study arms

  • Experimental
    A1

    Arformoterol 5 mcg BID for 14 days

    Drug: Arformoterol tartrate inhalation solution

  • Experimental
    A2

    Arformoterol 15 mcg BID for 14 days

    Drug: Arformoterol tartrate inhalation solution

  • Experimental
    A3

    Arformoterol 25 mcg BID for 14 days

    Drug: Arformoterol tartrate inhalation solution

  • Placebo comparator
    A4

    Placebo inhalation solution BID for 14 days

    Drug: Placebo

  • Experimental
    B1

    Arformoterol 15 mcg QD for 14 days

    Drug: Arformoterol tartrate inhalation solution

  • Experimental
    B2

    Arformoterol 25 mcg QD for 14 days

    Drug: Arformoterol tartrate inhalation solution

  • Experimental
    B3

    Arformoterol 50 mcg QD for 14 days

    Drug: Arformoterol tartrate inhalation solution

  • Placebo comparator
    B4

    Placebo inhalation solution QD for 14 days

    Drug: Placebo

Interventions

  • DrugArformoterol tartrate inhalation solution

    Arformoterol 5 mcg BID

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

  • DrugArformoterol tartrate inhalation solution

    Arformoterol 15 mcg BID

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

  • DrugArformoterol tartrate inhalation solution

    Arformoterol 25 mcg BID

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

  • DrugPlacebo

    Placebo inhalation solution BID

  • DrugArformoterol tartrate inhalation solution

    Arformoterol 15 mcg QD

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

  • DrugArformoterol tartrate inhalation solution

    Arformoterol 25 mcg QD

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

  • DrugArformoterol tartrate inhalation solution

    Arformoterol 50 mcg QD

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

  • DrugPlacebo

    Placebo inhalation solution QD

06

What researchers measure

Primary outcomes

  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.

    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)

  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.

    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)

Secondary outcomes

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

    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)

  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.

    Time frame: 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.

    Time frame: 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).

    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)

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

    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)

  6. Peak percent change in FEV1 post-dose

    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)

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

    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)

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

    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)

  9. Exacerbations of COPD

    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)

  10. COPD symptom ratings

    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)

  11. Effects of withdrawal from therapy

    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)

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

    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)

  13. FEV1 percent change from pre-dose (24-hour trough) 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)

07

Study locations

31 sites
  • Encinitas, California, United States
  • Long Beach, California, United States
  • Brandon, Florida, United States
  • Cleawater, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Jacksonville, Florida, United States
  • Port Orange, Florida, United States
  • West Palm Beach, Florida, United States
  • Austell, Georgia, United States
  • Topeka, Kansas, United States
  • Marrero, Louisiana, United States
  • New Orleans, Louisiana, United States
  • Opelousas, Louisiana, United States
  • McCook, Nebraska, United States
  • Princeton, New Jersey, United States
  • Hickory, North Carolina, United States
  • Statesville, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Columbus, Ohio, United States
  • Eugene, Oregon, United States
  • Medford, Oregon, United States
  • Pittsburg, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Columbia, South Carolina, United States
  • Simpsonville, South Carolina, United States
  • Spartanburg, South Carolina, United States
  • Austin, Texas, United States
  • San Antonio, Texas, United States
  • Renton, Washington, United States
  • Spokane, Washington, United States
  • Tacoma, Washington, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00691405
Lead sponsor
Sumitomo Pharma America, Inc.
Responsible party
Sponsor
First posted
Jun 5, 2008
Start date
Oct 2003
Primary completion
May 2004
Completion
May 2004
Last update
Feb 22, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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