Reactive Airways Disease (RAD)Phase 3NCT00685126
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
A Phase 3 study testing Levalbuterol HCl Inhalation Solution and Albuterol HCl Inhalation Solution in people with Reactive Airways Disease (RAD), run by Sumitomo Pharma America, Inc. at 34 sites in 2 countries.
Trial summary
The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old. Read more about this study
- Who is it for?
- Ages Up to 48 months
- Conditions the study is for
- Reactive Airways Disease (RAD)
- What is being tested?
- Levalbuterol HCl Inhalation Solution and Albuterol HCl Inhalation Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Feb 2001to Jul 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 Up to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject, male or female, must be between the ages of birth to 48 months inclusive at the time of consent.
- Subject must have experienced at least one previous episode or have a history of reactive airways disease.
- Subject must have an Oxygen saturation ≥ 90% at room air or with no more than 2 L/min supplemental Oxygen.
Who cannot join
- Subject who has participated in an investigational drug study within 30 days prior to study start, or who has previously participated in this study.
- Subject with a known sensitivity to levalbuterol or racemic albuterol, including Ventolin® or any of the excipients contained in any of these formulations.
- Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States32 sites
Study site
Bloomington, Illinois
Study site
Burke, Virginia
Study site
Charleston, West Virginia
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Corona, California
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Englewood, California
Study site
Houston, Texas
Study site
Huntington Beach, California
Study site
Indianapolis, Indiana
Study site
Lake Worth, Florida
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Long Beach, California
Study site
Louisville, Kentucky
Study site
Marrero, Louisiana
Study site
Medford, Oregon
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Omaha, Nebraska
Study site
Oswego, Ohio
Study site
Raleigh, North Carolina
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Shreveport, Louisiana
Study site
Tampa, Florida
Study site
Washington D.C., District of Columbia
Study site
Winston-Salem, North Carolina
Canada2 sites
Study site
Halifax, Nova Scotia
Study site
Saskatoon, Saskatchewan
About this study
Official title: A Safety, Tolerability and Efficacy Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects Birth to 48 Months Old With Reactive Airways Disease in an Acute Setting
The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.
Read the detailed description
A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease. 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
- Reactive Airways Disease (RAD)
- Being tested
- Levalbuterol HCl Inhalation Solution, Albuterol HCl Inhalation Solution
- Keywords
- RAD, Reactive Airways Disease, Levalbuterol, Racemic albuterol
- 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.
Levalbuterol HCl Inhalation SolutionDrug
Also called Xopenex UDV, Xopenex Inhalation Solution, R-albuterol
Nebulized unit dose vial for inhalation, low dose (0.15 mg, 0.31 mg or 0.63 mg), adjusted for body weight
Levalbuterol HCl Inhalation SolutionDrug
Also called Xopenex UDV, Xopenex Inhalation Solution, R-albuterol
Nebulized unit dose vial for inhalation, high dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
Albuterol HCl Inhalation SolutionDrug
Also called Ventolin, RS-albuterol
Nebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Low dose levalbuterol (0.15 mg, 0.31 mg or 0.63 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion.
Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID). Receives: Drug: Levalbuterol HCl Inhalation Solution |
| B | Experimental | High dose levalbuterol (0.31 mg, 0.63 mg or 1.25 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion.
Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID). Receives: Drug: Levalbuterol HCl Inhalation Solution |
| C | Active comparator | Racemic albuterol (0.63, 1.25 mg or 2.5 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion.
Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID). Receives: Drug: Albuterol HCl Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum decrease in Respiratory Status Scale© total score
Measured: Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged
Secondary outcomes (5)
Time to meet discharge criteria or clinical decision to discharge.
Measured: Days 0-7
Time to maximum decrease in Respiratory Status Scale© total score.
Measured: Days 0-7
Individual Respiratory Status Scale© items.
Measured: Days 0-7
Time to hospitalization.
Measured: Days 0-7
Rate of hospitalization.
Measured: Days 0-7
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 2001
- Primary completionJul 2002
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reactive Airways Disease (RAD)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
- 117 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
- NCT00685126
- Sponsor's protocol ID
- 051-033
- 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 Safety, Tolerability and Efficacy Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects Birth to 48 Months Old With Reactive Airways Disease in an Acute Setting
- ClinicalTrials.gov ID
- NCT00685126
- Acronym / sponsor ID
- 051-033
- Conditions
- Reactive Airways Disease (RAD)
- Keywords
- RAD, Reactive Airways Disease, Levalbuterol, Racemic albuterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Jul 2002 (actual)
- Study completion
- Jul 2002 (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 efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.
Detailed description
A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Levalbuterol HCl Inhalation SolutionLow dose levalbuterol (0.15 mg, 0.31 mg or 0.63 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion. Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID). |
| B | Experimental | Drug: Levalbuterol HCl Inhalation SolutionHigh dose levalbuterol (0.31 mg, 0.63 mg or 1.25 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion. Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID). |
| C | Active comparator | Drug: Albuterol HCl Inhalation SolutionRacemic albuterol (0.63, 1.25 mg or 2.5 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion. Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID). |
Who may qualify
- Ages
- Up to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject, male or female, must be between the ages of birth to 48 months inclusive at the time of consent.
- Subject must have experienced at least one previous episode or have a history of reactive airways disease.
- Subject must have an Oxygen saturation ≥ 90% at room air or with no more than 2 L/min supplemental Oxygen.
Key exclusion criteria (3 listed)
- Subject who has participated in an investigational drug study within 30 days prior to study start, or who has previously participated in this study.
- Subject with a known sensitivity to levalbuterol or racemic albuterol, including Ventolin® or any of the excipients contained in any of these formulations.
- Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
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 HCl Inhalation SolutionAlso: Xopenex UDV, Xopenex Inhalation Solution, R-albuterolNebulized unit dose vial for inhalation, low dose (0.15 mg, 0.31 mg or 0.63 mg), adjusted for body weight | Drug | A |
| Levalbuterol HCl Inhalation SolutionAlso: Xopenex UDV, Xopenex Inhalation Solution, R-albuterolNebulized unit dose vial for inhalation, high dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight | Drug | B |
| Albuterol HCl Inhalation SolutionAlso: Ventolin, RS-albuterolNebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight | Drug | C |
Primary outcome
Maximum decrease in Respiratory Status Scale© total score
Time frame: Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged
5 secondary outcomes
Time to meet discharge criteria or clinical decision to discharge.
Time frame: Days 0-7
Time to maximum decrease in Respiratory Status Scale© total score.
Time frame: Days 0-7
Individual Respiratory Status Scale© items.
Time frame: Days 0-7
Time to hospitalization.
Time frame: Days 0-7
Rate of hospitalization.
Time frame: Days 0-7
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.
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.
34 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 Inhalation Solution and Albuterol HCl Inhalation Solution in people with Reactive Airways Disease (RAD), run by Sumitomo Pharma America, Inc. at 34 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 3 inclusion and 3 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 34 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. 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?
Maximum decrease in Respiratory Status Scale© total score (time frame: Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged). 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.