AsthmaPhase 2NCT00684866
Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma
A Phase 2 study testing Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI and Racemic Albuterol followed by levalbuterol HFA MDI in people with Asthma, run by Sumitomo Pharma America, Inc. at 11 sites in United States.
Trial summary
The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI and Racemic Albuterol followed by levalbuterol HFA MDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2003to Jul 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 4 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 4 to 11 years, inclusive, at the time of consent.
- Female subjects who are 8 years of age or older will have a negative serum pregnancy test at study start.
- 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 or have one taken within 12 months prior to randomization may be used.
- 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 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 prior to study start, or who is currently participating in another clinical trial.
- Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM.
- 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
- Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations.
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- 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.
- 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 2 weeks prior to study start.
- Subject 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
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Chester, Pennsylvania
Study site
Cortland, New York
Study site
Dallas, Texas
Study site
Houston, Texas
Study site
Knoxville, Tennessee
Study site
Louisville, Kentucky
Study site
Madera, California
Study site
Medford, Oregon
Study site
Portland, Oregon
Study site
San Diego, California
Study site
Savannah, Georgia
About this study
Official title: A Cumulative Dose Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatric Subjects With Asthma
The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma
Read the detailed description
A randomized, double-blind, active-controlled multicenter, two-way crossover study of HFA levalbuterol (with and without a spacer) in subjects 4-11 years of age with asthma. 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 HFA MDI followed by Racemic albuterol HFA MDI, Racemic Albuterol followed by levalbuterol HFA MDI
- Keywords
- Asthma, Levalbuterol, Racemic Albuterol
- 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 MDI followed by Racemic albuterol HFA MDIDrug
Also called Xopenex HFA MDI, albuterol HFA MDI
(a) Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses)
Racemic Albuterol followed by levalbuterol HFA MDIDrug
Also called albuterol HFA MDI, Xopenex HFA MDI
(a) Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (8 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (8 cumulative doses).
The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects. Receives: Drug: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI |
| B | Active comparator | Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects. Receives: Drug: Racemic Albuterol followed by levalbuterol HFA MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic), potassium and glucose
Measured: 0, 7, 10 days
Secondary outcomes (4)
Percent change in FEV1 (from visit pre-dose to each post dose measure)
Measured: Days 0, 7, 10
Percent change in FVC (from visit pre-dose to each post dose measure)
Measured: Days 0, 7, 10
Percent change in FEF25-75% (from visit pre-dose to each post dose measure)
Measured: Days 0, 7, 10
Number of cumulative actuations received
Measured: Days 0, 7, 10
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 completionJul 2003
- Study completionJul 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 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
- NCT00684866
- Sponsor's protocol ID
- 051-311
- 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 Cumulative Dose Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatric Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00684866
- Acronym / sponsor ID
- 051-311
- Conditions
- Asthma
- Keywords
- Asthma, Levalbuterol, Racemic Albuterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 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 compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma
Detailed description
A randomized, double-blind, active-controlled multicenter, two-way crossover study of HFA levalbuterol (with and without a spacer) in subjects 4-11 years of age with asthma. 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
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDISubjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (8 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (8 cumulative doses). The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects. |
| B | Active comparator | Drug: Racemic Albuterol followed by levalbuterol HFA MDISubjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects. |
Who may qualify
- Ages
- 4 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 4 to 11 years, inclusive, at the time of consent.
- Female subjects who are 8 years of age or older will have a negative serum pregnancy test at study start.
- 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 or have one taken within 12 months prior to randomization may be used.
Key exclusion criteria (16 listed)
- 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 clinical trial.
- Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM.
- 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
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 MDI followed by Racemic albuterol HFA MDIAlso: Xopenex HFA MDI, albuterol HFA MDI(a) Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) | Drug | A |
| Racemic Albuterol followed by levalbuterol HFA MDIAlso: albuterol HFA MDI, Xopenex HFA MDI(a) Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) | Drug | B |
Primary outcome
Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic), potassium and glucose
Time frame: 0, 7, 10 days
4 secondary outcomes
Percent change in FEV1 (from visit pre-dose to each post dose measure)
Time frame: Days 0, 7, 10
Percent change in FVC (from visit pre-dose to each post dose measure)
Time frame: Days 0, 7, 10
Percent change in FEF25-75% (from visit pre-dose to each post dose measure)
Time frame: Days 0, 7, 10
Number of cumulative actuations received
Time frame: Days 0, 7, 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.
11 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 followed by Racemic albuterol HFA MDI and Racemic Albuterol followed by levalbuterol HFA MDI in people with Asthma, run by Sumitomo Pharma America, Inc. at 11 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 16 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 11 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?
Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic), potassium and glucose (time frame: 0, 7, 10 days). 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.