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.
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
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 group | Role | What they receive |
|---|---|---|
| A | Experimental | Arformoterol 50 mcg QD and placebo MDI Receives: Drug: Arformoterol tartrate inhalation solution |
| B | Experimental | Arformoterol 25 mcg BID and placebo MDI Receives: Drug: Arformoterol tartrate inhalation solution |
| C | Experimental | Arformoterol 15 mcg BID and placebo MDI Receives: Drug: Arformoterol tartrate inhalation solution |
| D | Active comparator | Salmeterol MDI 42 mcg BID and placebo inhalation solution Receives: Drug: Salmeterol MDI |
| E | Placebo comparator | Placebo 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.
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)
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
Peak percent of predicted FEV1
Measured: 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)
Measured: 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)
Measured: Weeks -2, 0, 3, 6, 9, 12
Timepoint changes in FEV1
Measured: Weeks -2, 0, 3, 6, 9, 12
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, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Ipratropium bromide MDI use
Measured: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Racemic albuterol MDI use
Measured: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Exacerbations of COPD
Measured: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 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
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.
- First posted28 May 2008 (estimated)
- Study startFeb 2002
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 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
- NCT00685841
- Acronym / sponsor ID
- 091-050
- Conditions
- COPD
- Keywords
- Chronic obstructive pulmonary disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 717 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 28 May 2008 (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.
A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.
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.
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 |
|---|---|---|
| A | Experimental | Drug: Arformoterol tartrate inhalation solutionArformoterol 50 mcg QD and placebo MDI |
| B | Experimental | Drug: Arformoterol tartrate inhalation solutionArformoterol 25 mcg BID and placebo MDI |
| C | Experimental | Drug: Arformoterol tartrate inhalation solutionArformoterol 15 mcg BID and placebo MDI |
| D | Active comparator | Drug: Salmeterol MDISalmeterol MDI 42 mcg BID and placebo inhalation solution |
| E | Placebo comparator | Drug: PlaceboPlacebo BID MDI and inhalation solution |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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:
- 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).
Key exclusion criteria (0 listed)
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-)formoterol, BrovanaArformoterol 50 mcg QD | Drug | A |
| Arformoterol tartrate inhalation solutionAlso: (R,R)-formoterol, BrovanaArformoterol 25 mcg BID | Drug | B |
| Arformoterol tartrate inhalation solutionAlso: (R,R)-formoterol, BrovanaArformoterol 15 mcg BID | Drug | C |
| Salmeterol MDIAlso: SereventSalmeterol MDI 42 mcg BID | Drug | D |
| PlaceboPlacebo BID MDI | Drug | E |
Primary outcome
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
13 secondary outcomes
Time-normalized area under the percent change from visit pre-dose curve for FEV1 over 12 hours (nAUC0-12)
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 from study baseline curve for FEV1 over 12 hours (nAUC0-12)
Time frame: 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)
Time frame: Weeks -2, 0, 3, 6, 9, 12
Timepoint changes in FEV1
Time frame: Weeks -2, 0, 3, 6, 9, 12
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, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Ipratropium bromide MDI use
Time frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Racemic albuterol MDI use
Time frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Exacerbations of COPD
Time frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
COPD symptom ratings (over 12 weeks of treatment)
Time frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Relationship between plasma concentrations of (R,R) formoterol and selected pharmacodynamic parameters
Time frame: Weeks -2, 0, 3, 6, 9, 12
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 2 Nov 2012.
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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.
52 sites in 1 country: see every site and its status.
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?
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.