Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00665600
Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Levalbuterol HCl and Albuterol Sulfate in people with Chronic Obstructive Pulmonary Disease (COPD), run by Sumitomo Pharma America, Inc. at 24 sites in 2 countries.
Trial summary
To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD. Read more about this study
- Who is it for?
- Ages 35 to 99 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Levalbuterol HCl and Albuterol Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Feb 2002to Mar 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects must be at least greater than or equal to 35 years of age at the time of consent.
- Subjects must have a pre-established primary clinical diagnosis of COPD.
- Subjects must have a baseline FEV1 less than or equal to 65%
- Subjects must have a predicted and >0.70 Liter
- subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days
- Subjects must have a FEV1/forced vital capacity (FVC) less than or equal to 70%
Show all 10Show fewer
- Subjects must have a greater than or equal to 15 pack-year smoking history
- Subjects must have a baseline medical research council (MRC) dyspnea scale score greater than or equal to 2
- Regular use of a prescribed therapy for control of COPD symptoms for 3 months prior to study entry.
- No COPD exacerbations that have required an emergency room visit, hospital admission or intensive out-patient therapy within 1 month prior to study entry
Who cannot join
- Females who are pregnant or lactating.
- Concurrent requirement of oxygen therapy
- Known history of asthma, or any chronic respiratory disease other than COPD (not including chronic bronchitis or emphysema).
- Diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer.
- Lung resection of more than one full lobe.
- Use of intravenous, intra-articular or intramuscular corticosteroids within 30 days of study entry
- History of upper or lower respiratory infection within 14 days of study entry.
- Participation in an investigational drug study within 30 days of study entry.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States20 sites
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Cadillac, Michigan
Study site
Carmichael, California
Study site
Chapel Hill, North Carolina
Study site
Columbia, Missouri
Study site
Elk Grove Village, Illinois
Study site
Hines, Illinois
Study site
Largo, Florida
Study site
Miami, Florida
Study site
Missoula, Montana
Study site
Mogadore, Ohio
Study site
Panama City, Florida
Study site
Providence, Rhode Island
Study site
San Antonio, Texas
Study site
Spring Valley, California
Study site
Springfield, Massachusetts
Study site
Springfield, New Jersey
Study site
Wheat Ridge, Colorado
Study site
Wheaton, Maryland
Canada4 sites
Study site
Calgary, Alberta
Study site
Mississauga, Ontario
Study site
Toronto, Ontario
Study site
Winnepeg, Manitoba
About this study
Official title: A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.
Read the detailed description
This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine 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.
- Being tested
- Levalbuterol HCl, Albuterol Sulfate, Placebo
- Keywords
- COPD, Chronic Bronchitis, Chronic Emphysema
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levalbuterol HClDrug
Also called Xopenex HCl Inhalation Solution
Levalbuterol 0.63 TID
Levalbuterol HClDrug
Also called Xopenex HCl Inhalation Solution
Levabuterol 1.25 mg TID
Albuterol SulfateDrug
Also called Ventolin Inhalation Solution
Racemic albuterol 2.5 mg TID
PlaceboDrug
Placebo TID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Levalbuterol 0.63 mg TID Receives: Drug: Levalbuterol HCl |
| 2 | Experimental | Levalbuterol 1.25 mg TID Receives: Drug: Levalbuterol HCl |
| 3 | Active comparator | Racemic Albuterol 2.5 mg TID Receives: Drug: Albuterol Sulfate |
| 4 | Placebo comparator | Placebo TID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint was the time-normalized area under the percent change from visit predose in FEV1 curve (nAUC0-8 hours) averaged over the six week double-blind period.
Measured: Days -21, -14, 0, 14, 28, and 42
Secondary outcomes (8)
Spirometry parameters
Measured: Days -21, -14, 0, 14, 28, and 42
Exacerbations of COPD
Measured: Days -14, 0, 14, 28, 42
COPD symptom ratings
Measured: Days 0, 14, 28, 42
Baseline dyspnea and transitional dyspnea indices
Measured: Days 0, 14, 28, 42
Ipatropium Bromide MDI use
Measured: Day 0, 14, 28, 42
Short acting Beta-agonist MDI use
Measured: Days 0, 14, 28, 42
Subject and physician global evaluations
Measured: Days 14, 28, 42
St. George's Hospital Respiratory Questionnaire (SGRQ).
Measured: Days 0, 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startFeb 2002
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 257 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
- NCT00665600
- Sponsor's protocol ID
- 051-914
- Status last verified
- Jun 2023
- First submitted
- 22 Apr 2008
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00665600
- Acronym / sponsor ID
- 051-914
- Keywords
- COPD, Chronic Bronchitis, Chronic Emphysema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 24 Apr 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.
To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.
Detailed description
This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levalbuterol HClLevalbuterol 0.63 mg TID |
| 2 | Experimental | Drug: Levalbuterol HClLevalbuterol 1.25 mg TID |
| 3 | Active comparator | Drug: Albuterol SulfateRacemic Albuterol 2.5 mg TID |
| 4 | Placebo comparator | Drug: PlaceboPlacebo TID |
Who may qualify
- Ages
- 35 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects must be at least greater than or equal to 35 years of age at the time of consent.
- Subjects must have a pre-established primary clinical diagnosis of COPD.
- Subjects must have a baseline FEV1 less than or equal to 65%
- Subjects must have a predicted and >0.70 Liter
- subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days
Key exclusion criteria (8 listed)
- Females who are pregnant or lactating.
- Concurrent requirement of oxygen therapy
- Known history of asthma, or any chronic respiratory disease other than COPD (not including chronic bronchitis or emphysema).
- Diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer.
- Lung resection of more than one full lobe.
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 |
|---|---|---|
| Levalbuterol HClAlso: Xopenex HCl Inhalation SolutionLevalbuterol 0.63 TID | Drug | 1 |
| Levalbuterol HClAlso: Xopenex HCl Inhalation SolutionLevabuterol 1.25 mg TID | Drug | 2 |
| Albuterol SulfateAlso: Ventolin Inhalation SolutionRacemic albuterol 2.5 mg TID | Drug | 3 |
| PlaceboPlacebo TID | Drug | 4 |
Primary outcome
The primary efficacy endpoint was the time-normalized area under the percent change from visit predose in FEV1 curve (nAUC0-8 hours) averaged over the six week double-blind period.
Time frame: Days -21, -14, 0, 14, 28, and 42
8 secondary outcomes
Spirometry parameters
Time frame: Days -21, -14, 0, 14, 28, and 42
Exacerbations of COPD
Time frame: Days -14, 0, 14, 28, 42
COPD symptom ratings
Time frame: Days 0, 14, 28, 42
Baseline dyspnea and transitional dyspnea indices
Time frame: Days 0, 14, 28, 42
Ipatropium Bromide MDI use
Time frame: Day 0, 14, 28, 42
Short acting Beta-agonist MDI use
Time frame: Days 0, 14, 28, 42
Subject and physician global evaluations
Time frame: Days 14, 28, 42
St. George's Hospital Respiratory Questionnaire (SGRQ).
Time frame: Days 0, 42
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 27 Jun 2023.
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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.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levalbuterol HCl and Albuterol Sulfate in people with Chronic Obstructive Pulmonary Disease (COPD), run by Sumitomo Pharma America, Inc. at 24 sites in 2 countries.
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 10 inclusion and 8 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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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?
The primary efficacy endpoint was the time-normalized area under the percent change from visit predose in FEV1 curve (nAUC0-8 hours) averaged over the six week double-blind period. (time frame: Days -21, -14, 0, 14, 28, and 42). 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 27 Jun 2023.