Chronic Obstructive Pulmonary DiseasePhase 3NCT00064402

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

A Phase 3 study testing arformoterol tartrate inhalation solution and Salmeterol in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by Sumitomo Pharma America, Inc. at 65 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

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 Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema
What is being tested?: arformoterol tartrate inhalation solution and Salmeterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 741 participants
Where: 65 sitesUnited States
Study dates: Apr 2002to Mar 2004
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

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

Who cannot join

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)

Show all 14Show fewer

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)

Trial locations and contacts

65 sites in 1 country.

City, postcode or hospital

65 sites in 1 country

United States65 sites

Northeast Clinical Research Centers, Inc.
Allentown, Pennsylvania, 18104
Keystone Clinical Solutions
Altoona, Pennsylvania, 16602
ClinSite, Inc.
Ann Arbor, Michigan, 48106
Protocare Trial, Inc.
Austell, Georgia, 30106
University of Maryland-Airways Research Center
Baltimore, Maryland
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, 98225
Pro-Medica Clinical Research Center
Boston, Massachusetts, 02135
Office of Keith Popovich, MD
Butte, Montana
Pulmonary Medicine
Chapel Hill, North Carolina, 27599
Charlotte Lung and Health Center
Charlotte, North Carolina, 28207
New Horizons Clinical Research, Inc.
Cincinnati, Ohio, 45241
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
University Clinical Research, DeLand
DeLand, Florida, 32720
Colorado Pulmonary Associates
Denver, Colorado, 80218
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914
Northern California Research Corp.
Fair Oaks, California, 95628
Northern Colorado Pulmonary Consultants, PC
Fort Collins, Colorado
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22401
SARC Research Center
Fresno, California, 93720
California Research Medical Group, Inc.
Fullerton, California, 92835
Physicians Research Center, Inc.
Hartford, Connecticut, 06106
Breath of Life Research Institute
Houston, Texas, 77084
Radiant Research-Irvine
Irvine, California, 92618
Pulmonary & Sleep Associates of Jasper, PC
Jasper, Alabama, 35501
Volunteer Research Group
Knoxville, Tennessee, 37920
Bendel Medical Associates/Research
Lafayette, Louisiana, 70503
Advanced Biomedical Research of America
Las Vegas, Nevada, 89119
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215
University of Wisconsin-Medical School
Madison, Wisconsin, 53792
Marietta Pulmonary Medicine
Marietta, Georgia, 30060
Mt. Sinai Medical Center
Miami Beach, Florida, 33140
Montana Medical Research, LLC
Missoula, Montana
Central Texas Health Research
New Braunfels, Texas, 78130
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
New Orleans Center for Clinical Research
New Orleans, Louisiana
West Coast Clinical Trials
Newport Beach, California
Office of Bradley Sakran, MD, PC
O'Fallon, Illinois, 62269
COR Clinical Research LLC
Oklahoma City, Oklahoma, 73103
VA Medical Center
Omaha, Nebraska
Center for Clinical Trials, LLC
Paramount, California, 90723
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, 19146
Pulmonary Associates, PA
Phoenix, Arizona, 85006
Allergy Associates Research Center
Portland, Oregon, 97213
Advances in Medicine
Rancho Mirage, California, 92270
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225
Consortium Clinical Research, Ltd.
Ridley Park, Pennsylvania, 19078
Midwest Chest Consultants, PC
Saint Charles, Missouri, 63301-2847
Sylvana Research Associates
San Antonio, Texas, 78229
Institute of Healthcare Assessment, Inc.
San Diego, California, 92120
San Jose Clinical Research
San Jose, California
North Shore Research Associates
Slidell, Louisiana, 70461
Cumberland Lung and Sleep Specialists
Somerset, Kentucky
South Bend Clinic
South Bend, Indiana, 46617
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina, 29307
MedEx HealthCare Research, Inc.
St Louis, Missouri, 63108
C.A.R.E Clinical Research
St Louis, Missouri, 63122
Carolina Pharmaceutical Research, Inc.
Statesville, North Carolina, 28625
Sunset Medical Research
Sunset, Louisiana, 70584
Clinical Pharmacology Services
Tampa, Florida, 33617
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85712
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, 94598
Washington Hospital Center
Washington D.C., District of Columbia
Institute of Asthma and Allergy
Wheaton, Maryland
New Hanover Medical Research
Wilmington, North Carolina, 28412

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

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

Read the 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.

Conditions: Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema
Being tested: arformoterol tartrate inhalation solution, Salmeterol, Placebo
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema

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
arformoterol 50 mcg QD
arformoterol tartrate inhalation solutionDrug
Also called (R,R)-formoterol
arformoterol 25 mcg BID
arformoterol tartrate inhalation solutionDrug
Also called (R,R)-formoterol, Brovana
arformoterol 15 mcg BID
SalmeterolDrug
Also called Serevent MDI
Salmeterol MDI 42 mcg BID
PlaceboDrug
Placebo BID

Study groups in NCT00064402
Study group	Role	What they receive
1	Experimental	Arformoterol 50 mcg QD and placebo MDI Receives: Drug: arformoterol tartrate inhalation solution
2	Experimental	Arformoterol 25 mcg BID and Placebo MDI Receives: Drug: arformoterol tartrate inhalation solution
3	Experimental	Arformoterol 15 mcg BID and placebo MDI Receives: Drug: arformoterol tartrate inhalation solution
4	Active comparator	Salmeterol MDI 42 mcg BID and placebo inhalation solution Receives: Drug: Salmeterol
5	Placebo comparator	Placebo MDI and placebo inhalation solution Receives: Drug: Placebo

What is being measured

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

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

Secondary outcomes (16)

time-normalized area under the percent change from visit predose curve for FEV1 over 12 hours (nAUC0-12-P)
Measured: Weeks -2, 0, 3, 6, 9, 12
Peak percent of predicted FEV1
Measured: Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change in FEV1 from study baseline over 12 hours (nAUC0-12-B)
Measured: Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change from visit predose curve for FEV1 over 24 hours (nAUC0-24-P)
Measured: Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change in FEV1 from study baseline curve over 24 hours (nAUC0-24-B)
Measured: Weeks -2, 0, 3, 6, 9, 12
peak percent change in FEV1 from visit predose and study baseline
Measured: Weeks -2, 0, 3, 6, 9, 12
time point changes in FEV1; time to onset of response
Measured: Weeks -2, 0, 3, 6, 9, 12
time to peak change in FEV1
Measured: Weeks -2, 0, 3, 6, 9, 12
at-home and in-clinic peak expiratory flow rate (PEFR)
Measured: Weeks -2, 0, 3, 6, 9, 12
relationship between the plasma concentration values and selected pharmacodynamic parameters
Measured: Weeks -2, 0, 3, 6, 9, 12, 13
Supplemental ipratropium bromide MDI and racemic albuterol MDI use
Measured: Weeks 0-13
COPD exacerbations and COPD symptom ratings
Measured: Weeks 0-13
St. George's Hospital Respiratory Questionnaire
Measured: Weeks 0, 6, 13
Investigator and Subject Global Evaluations
Measured: Weeks -2, 12, 13
Baseline and Transitional Dyspnea Index
Measured: Weeks -2, 6, 12
distance walked in six minutes
Measured: Weeks -2, 3, 9

Timeline

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

Apr 2002Mar 2004

First posted9 Jul 2003 (estimated)
Study startApr 2002
Primary completionMar 2004
Study completionMar 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 741 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00064402
Sponsor's protocol ID: 091-051
Status last verified: Feb 2012
First submitted: 8 Jul 2003
Last updated: 22 Feb 2012
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00064402
Acronym / sponsor ID: 091-051
Conditions: Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 741 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2002
Primary completion: Mar 2004 (actual)
Study completion: Mar 2004 (actual)
First posted: 9 Jul 2003 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
1	Experimental	Drug: arformoterol tartrate inhalation solutionArformoterol 50 mcg QD and placebo MDI
2	Experimental	Drug: arformoterol tartrate inhalation solutionArformoterol 25 mcg BID and Placebo MDI
3	Experimental	Drug: arformoterol tartrate inhalation solutionArformoterol 15 mcg BID and placebo MDI
4	Active comparator	Drug: SalmeterolSalmeterol MDI 42 mcg BID and placebo inhalation solution
5	Placebo comparator	Drug: PlaceboPlacebo MDI and placebo inhalation solution

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
arformoterol tartrate inhalation solutionAlso: (R,R)-formoterolarformoterol 50 mcg QD	Drug	1
arformoterol tartrate inhalation solutionAlso: (R,R)-formoterolarformoterol 25 mcg BID	Drug	2
arformoterol tartrate inhalation solutionAlso: (R,R)-formoterol, Brovanaarformoterol 15 mcg BID	Drug	3
SalmeterolAlso: Serevent MDISalmeterol MDI 42 mcg BID	Drug	4
PlaceboPlacebo BID	Drug	5

Primary outcome

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

16 secondary outcomes

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
Peak percent of predicted FEV1
Time frame: Weeks -2, 0, 3, 6, 9, 12
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
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
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
peak percent change in FEV1 from visit predose and study baseline
Time frame: Weeks -2, 0, 3, 6, 9, 12
time point changes in FEV1; time to onset of response
Time frame: Weeks -2, 0, 3, 6, 9, 12
time to peak change in FEV1
Time frame: Weeks -2, 0, 3, 6, 9, 12
at-home and in-clinic peak expiratory flow rate (PEFR)
Time frame: Weeks -2, 0, 3, 6, 9, 12
relationship between the plasma concentration values and selected pharmacodynamic parameters
Time frame: Weeks -2, 0, 3, 6, 9, 12, 13
Supplemental ipratropium bromide MDI and racemic albuterol MDI use
Time frame: Weeks 0-13
COPD exacerbations and COPD symptom ratings
Time frame: Weeks 0-13
St. George's Hospital Respiratory Questionnaire
Time frame: Weeks 0, 6, 13
Investigator and Subject Global Evaluations
Time frame: Weeks -2, 12, 13
Baseline and Transitional Dyspnea Index
Time frame: Weeks -2, 6, 12
distance walked in six minutes
Time frame: Weeks -2, 3, 9

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

65 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 14 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 65 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 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). 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 NCT00064402.

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.