AsthmaPhase 3NCT00667407
Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma
A Phase 3 study testing Levalbuterol 1.25 mg and Racemic Albuterol Sulfate in people with Asthma, run by Sumitomo Pharma America, Inc. at 28 sites in United States.
Trial summary
To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Levalbuterol 1.25 mg and Racemic Albuterol Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 627 participants
- Where
- 28 sitesUnited States
- Study dates
- Nov 2000to Aug 2002
- 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 18 years and older
- 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 18 years of age at the time of consent.
- Subjects must have history of asthma for at least 6 months.
- Subjects must present to the emergency department (ED) or clinic with forced expiratory volume in one second (FEV1) of 20 to 55% (inclusive) predicted at baseline
- Subjects must have O2 saturation greater than or equal to 90% at room air or with no more than 6 Liters/minute supplemental oxygen and no other cause of wheezing or shortness of breath other than asthma as determined by the physician.
- Prior use of a beta-agonist (e.g., Primatine Mist, albuterol, salmeterol, etc.) within 24 hours of presentation to the ED or Clinic.
- Smoked ≤ 10 pack-years or non-smoker.
Show all 9Show fewer
- Be in good health with the exception of asthma and not suffering from any chronic condition which might affect their lung function, such as COPD or emphysema.
- Near-normal activity level between exacerbations.
- Subjects who are taking inhaled or systemic corticosteroids must be on a stable dose for at least 21 days prior to study entry.
Who cannot join
- Subjects who have received treatment for asthma in an ED, Clinic, or Urgent Care Center within 2 weeks prior to study entry.
- Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema.
- Subjects with a history of asthma episodes associated with hypercapnia, respiratory arrest, hypoxic seizures, or requiring intubation within 12 months prior to entry.
- Hospitalization for asthma within two months prior to entry.
- Female subjects who are pregnant or lactating.
- Subjects who have a history of a clinically significant psychiatric disorder within the last 3 months, with the exception of mild depression.
- Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Study site
Akron, Ohio
Study site
Ann Arbor, Michigan
Study site
Brooklyn, New York
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Detroit, Michigan
Study site
Encinitas, California
Study site
Fresno, California
Study site
Gainesville, Florida
Study site
Hoover, Alabama
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Kansas City, Missouri
Study site
Lake Oswego, Oregon
Study site
Medford, Oregon
Study site
Metairie, Louisiana
Study site
Montgomery, Alabama
Study site
New Hyde Park, New York
Study site
Oakland, California
Study site
Philadelphia, Pennsylvania
Study site
Red Bank, New Jersey
Study site
Rocky Mount, North Carolina
Study site
Salt Lake City, Utah
Study site
St Louis, Missouri
Study site
Syracuse, New York
Study site
Tampa, Florida
Study site
Torrance, California
About this study
Official title: A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma
To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.
Read the detailed description
This study is a double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in adult subjects with acute reversible airways disease. Approximately 600 subjects will be enrolled and study participation will consist of 2 periods: Period I (Acute Period): Double-blind treatment in the Emergency Department (ED) or Clinic until disposition, for a maximum of 24 hours of double-blind treatment and Period II (Post-Acute Period): Subjects discharged from the ED or Clinic will continue double blind treatment (with the same treatment provided as rescue medication as MDI) for approximately 10 days. Subjects will be contacted by telephone 30 days post discharge to assess relapse. 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
- Asthma
- Being tested
- Levalbuterol 1.25 mg, Racemic Albuterol Sulfate
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levalbuterol 1.25 mgDrug
Also called Xopenex HCl Inhalation Solution
levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated.
Period II: TID for 3 days (same time of day), then PRN to TID for 7 days
Racemic Albuterol SulfateDrug
Also called Ventolin Inhalation Solution
Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated.
Period II: TID for 3 days then PRN to TID for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Levalbuterol 1.25 mg Receives: Drug: Levalbuterol 1.25 mg |
| 2 | Active comparator | Racemic Albuterol 2.5 mg Receives: Drug: Racemic Albuterol Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I.
Measured: 24 hours
Secondary outcomes (4)
FEV1 (Period I): Serial spirometry, maximum FEV1, time to maximum FEV1, baseline FEV1 severity on subject response; % responders, no. nebulizations to meet discharge criteria, rate of hospitalization, time to admit decision, rate for increased care
Measured: Day 0 (5-10 min after every dose)
FEV1 (Period II): Spirometry, average FEV1; distribution of subject responses; rate of relapse; blinded study medication; length of stay in ED or Clinic during Period I; length of hospitalization, cost of care
Measured: Days 3, 10
Investigator and subject global evaluations, subject preference
Measured: Days 3, 10
Subject reported beta-mediated side effects
Measured: Days 3, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startNov 2000
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 627 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
- NCT00667407
- Sponsor's protocol ID
- 051-915
- Status last verified
- Feb 2012
- First submitted
- 24 Apr 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
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 Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma
- ClinicalTrials.gov ID
- NCT00667407
- Acronym / sponsor ID
- 051-915
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2000
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 28 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 Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.
Detailed description
This study is a double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in adult subjects with acute reversible airways disease. Approximately 600 subjects will be enrolled and study participation will consist of 2 periods: Period I (Acute Period): Double-blind treatment in the Emergency Department (ED) or Clinic until disposition, for a maximum of 24 hours of double-blind treatment and Period II (Post-Acute Period): Subjects discharged from the ED or Clinic will continue double blind treatment (with the same treatment provided as rescue medication as MDI) for approximately 10 days. Subjects will be contacted by telephone 30 days post discharge to assess relapse. 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
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levalbuterol 1.25 mgLevalbuterol 1.25 mg |
| 2 | Active comparator | Drug: Racemic Albuterol SulfateRacemic Albuterol 2.5 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
- Subjects must have history of asthma for at least 6 months.
- Subjects must present to the emergency department (ED) or clinic with forced expiratory volume in one second (FEV1) of 20 to 55% (inclusive) predicted at baseline
- Subjects must have O2 saturation greater than or equal to 90% at room air or with no more than 6 Liters/minute supplemental oxygen and no other cause of wheezing or shortness of breath other than asthma as determined by the physician.
- Prior use of a beta-agonist (e.g., Primatine Mist, albuterol, salmeterol, etc.) within 24 hours of presentation to the ED or Clinic.
Key exclusion criteria (7 listed)
- Subjects who have received treatment for asthma in an ED, Clinic, or Urgent Care Center within 2 weeks prior to study entry.
- Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema.
- Subjects with a history of asthma episodes associated with hypercapnia, respiratory arrest, hypoxic seizures, or requiring intubation within 12 months prior to entry.
- Hospitalization for asthma within two months prior to entry.
- Female subjects who are pregnant or lactating.
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 1.25 mgAlso: Xopenex HCl Inhalation Solutionlevalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated. Period II: TID for 3 days (same time of day), then PRN to TID for 7 days | Drug | 1 |
| Racemic Albuterol SulfateAlso: Ventolin Inhalation SolutionRacemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated. Period II: TID for 3 days then PRN to TID for 7 days | Drug | 2 |
Primary outcome
Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I.
Time frame: 24 hours
4 secondary outcomes
FEV1 (Period I): Serial spirometry, maximum FEV1, time to maximum FEV1, baseline FEV1 severity on subject response; % responders, no. nebulizations to meet discharge criteria, rate of hospitalization, time to admit decision, rate for increased care
Time frame: Day 0 (5-10 min after every dose)
FEV1 (Period II): Spirometry, average FEV1; distribution of subject responses; rate of relapse; blinded study medication; length of stay in ED or Clinic during Period I; length of hospitalization, cost of care
Time frame: Days 3, 10
Investigator and subject global evaluations, subject preference
Time frame: Days 3, 10
Subject reported beta-mediated side effects
Time frame: Days 3, 10
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.
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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.
28 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 Levalbuterol 1.25 mg and Racemic Albuterol Sulfate in people with Asthma, run by Sumitomo Pharma America, Inc. at 28 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 7 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 28 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. 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?
Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I. (time frame: 24 hours). 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 22 Feb 2012.