AsthmaPhase 2NCT00685347
Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects
A Phase 2 study testing Levalbuterol HFA MDI and Racemic Albuterol in people with Asthma and Bronchoconstriction, run by Sumitomo Pharma America, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma, Bronchoconstriction
- What is being tested?
- Levalbuterol HFA MDI and Racemic Albuterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2003to Jun 2003
- Phase
- Phase 2
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject, male or female, must be between the ages of 6 to 11 years, inclusive, at the time of consent.
- Female subjects who are 8 years of age or older must have a negative serum pregnancy test.
- Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
- Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
- Subject must have a chest X-ray for the study or within 12 months prior to randomization.
- Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis and understand dosing instructions. Any minor subject who is not able to do this must have a parent/legal guardian who can assist them during the study with these activities.
Who cannot join
- Female subject who is pregnant or lactating.
- Subject who has participated in an investigational drug study within 30 days of study start, or who is currently participating in another clinical trial.
- Subject whose schedule prevents him or her from starting study visits before 2:30-4:00 PM.
- Subject who is unwilling or physically unable to perform the exercise challenges as described in the protocol.
- Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both.
- Subject who has a history of hospitalization for asthma within 4 weeks prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
Show all 17Show fewer
- Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations.
- Subject using any prescription drug with which albuterol sulfate administration is contraindicated.
- Subject with currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior to study start.
- Subject with a history of cancer (exception: basal cell carcinoma in remission).
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
- Subject with a history of substance abuse or drug abuse within 12 months preceding study start.
- Subject with a history of cigarette smoking or use of any tobacco products.
- Subject with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
- Subject who has suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start.
- Subjects with unstable asthma; or who have had a change in asthma therapy; or a visit to the Emergency Department or hospital for worsening asthma within 4 weeks.
- Subject who is a staff member or relative of a staff member.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Burke, Virginia
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Englewood, Colorado
Study site
Long Beach, California
Study site
Russells Mills, Massachusetts
About this study
Official title: A Dose Response Study of Levalbuterol and Racemic Albuterol HFA MDI in Pediatric Subjects With Asthma
The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma
Read the detailed description
A randomized, double-blind, active controlled, multicenter, parallel treatment, 3x3 dose level crossover study evaluating the dose response of levalbuterol in pediatric subjects between the ages of 6 and 11, inclusive with exercise induced bronchoconstriction. 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, Bronchoconstriction
- Being tested
- Levalbuterol HFA MDI, Racemic Albuterol
- Keywords
- Asthma, Exercised induced bronchoconstriction
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levalbuterol HFA MDIDrug
- levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each).
- Arm #A
- Xopenex HFA MDI
Racemic AlbuterolDrug
- racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg).
- Arm #B
- Proventil HFA MDI
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects randomized to the levalbuterol arm will complete 1 of 6 possible randomization sequences containing (a) levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each). Subjects will receive treatment, according to the randomization sequence, followed by a 5±2 day washout. Receives: Drug: Levalbuterol HFA MDI |
| B | Active comparator | Subjects randomized to racemic albuterol will complete 1 of 6 possible randomization sequences containing (a) racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg). Subjects will receive treatment, according to the randomization sequence, followed by a 5±2 day washout. Receives: Drug: Racemic Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum percent decrease in FEV1 from visit post-dose/pre-challenge FEV1
Measured: Days -7, 0, 5, 10, 15
Secondary outcomes (12)
Area under the percent decrease from visit post-dose/pre-challenge FEV1 curve
Measured: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit pre-dose FEV1 curve.
Measured: Days -7, 0, 5, 10, 15
Minimum percent change in FEV1 from visit pre-dose FEV1.
Measured: Days -7, 0, 5, 10, 15
Minimum percent change in FEV1 from visit post dose/pre-challenge FEV1
Measured: Days -7, 0, 5, 10, 15
percent change in FEV1 from visit predose to the post-dose/pre-challenge FEV1
Measured: Days -7, 0, 5, 10, 15
Time to recovery (min), Protected/Unprotected Subjects Counts
Measured: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit post-dose/pre-challenge FVC,
Measured: Days -7, 0, 5, 10, 15
Maximum percent decrease in FVC from visit post-dose/pre-challenge FVC
Measured: Days -7, 0, 5, 10, 15
Minimum percent change in FVC from pre-dose FVC
Measured: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit post-dose/pre-challenge FEF25%-75% curve
Measured: Days -7, 0, 5, 10, 15
Maximum percent decrease in FEF25-75% from visit post-dose/pre-challenge FEF25-75%
Measured: Days -7, 0, 5, 10, 15
Minimum percent change in FEF25%-75% from visit pre-dose FEF25-75%.
Measured: Days -7, 0, 5, 10, 15
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 startJan 2003
- 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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 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
- NCT00685347
- Sponsor's protocol ID
- 051-312
- Status last verified
- Feb 2012
- First submitted
- 23 May 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 Dose Response Study of Levalbuterol and Racemic Albuterol HFA MDI in Pediatric Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00685347
- Acronym / sponsor ID
- 051-312
- Conditions
- Asthma, Bronchoconstriction
- Keywords
- Asthma, Exercised induced bronchoconstriction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- 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.
The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma
Detailed description
A randomized, double-blind, active controlled, multicenter, parallel treatment, 3x3 dose level crossover study evaluating the dose response of levalbuterol in pediatric subjects between the ages of 6 and 11, inclusive with exercise induced bronchoconstriction. 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 |
|---|---|---|
| A | Experimental | Drug: Levalbuterol HFA MDISubjects randomized to the levalbuterol arm will complete 1 of 6 possible randomization sequences containing (a) levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each). Subjects will receive treatment, according to the randomization sequence, followed by a 5±2 day washout. |
| B | Active comparator | Drug: Racemic AlbuterolSubjects randomized to racemic albuterol will complete 1 of 6 possible randomization sequences containing (a) racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg). Subjects will receive treatment, according to the randomization sequence, followed by a 5±2 day washout. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject, male or female, must be between the ages of 6 to 11 years, inclusive, at the time of consent.
- Female subjects who are 8 years of age or older must have a negative serum pregnancy test.
- Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
- Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
- Subject must have a chest X-ray for the study or within 12 months prior to randomization.
Key exclusion criteria (17 listed)
- Female subject who is pregnant or lactating.
- Subject who has participated in an investigational drug study within 30 days of study start, or who is currently participating in another clinical trial.
- Subject whose schedule prevents him or her from starting study visits before 2:30-4:00 PM.
- Subject who is unwilling or physically unable to perform the exercise challenges as described in the protocol.
- Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both.
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 HFA MDI1. levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each). 2. Arm #A 3. Xopenex HFA MDI | Drug | A |
| Racemic Albuterol1. racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg). 2. Arm #B 3. Proventil HFA MDI | Drug | B |
Primary outcome
Maximum percent decrease in FEV1 from visit post-dose/pre-challenge FEV1
Time frame: Days -7, 0, 5, 10, 15
12 secondary outcomes
Area under the percent decrease from visit post-dose/pre-challenge FEV1 curve
Time frame: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit pre-dose FEV1 curve.
Time frame: Days -7, 0, 5, 10, 15
Minimum percent change in FEV1 from visit pre-dose FEV1.
Time frame: Days -7, 0, 5, 10, 15
Minimum percent change in FEV1 from visit post dose/pre-challenge FEV1
Time frame: Days -7, 0, 5, 10, 15
percent change in FEV1 from visit predose to the post-dose/pre-challenge FEV1
Time frame: Days -7, 0, 5, 10, 15
Time to recovery (min), Protected/Unprotected Subjects Counts
Time frame: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit post-dose/pre-challenge FVC,
Time frame: Days -7, 0, 5, 10, 15
Maximum percent decrease in FVC from visit post-dose/pre-challenge FVC
Time frame: Days -7, 0, 5, 10, 15
Minimum percent change in FVC from pre-dose FVC
Time frame: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit post-dose/pre-challenge FEF25%-75% curve
Time frame: Days -7, 0, 5, 10, 15
Maximum percent decrease in FEF25-75% from visit post-dose/pre-challenge FEF25-75%
Time frame: Days -7, 0, 5, 10, 15
Minimum percent change in FEF25%-75% from visit pre-dose FEF25-75%.
Time frame: Days -7, 0, 5, 10, 15
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levalbuterol HFA MDI and Racemic Albuterol in people with Asthma and Bronchoconstriction, run by Sumitomo Pharma America, Inc. at 6 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 6 inclusion and 17 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 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Maximum percent decrease in FEV1 from visit post-dose/pre-challenge FEV1 (time frame: Days -7, 0, 5, 10, 15). 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.