AsthmaPhase 3NCT00073814
Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
A Phase 3 study testing Levalbuterol tartrate MDI and racemic albuterol MDI in people with Asthma, run by Sumitomo Pharma America, Inc. at 45 sites in United States.
Trial summary
Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects 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 tartrate MDI and racemic albuterol MDI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 45 sitesUnited States
- Study dates
- Dec 2002to Jun 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject and subject's p/l guardian must be willing and able to comply with the study procedures and visit schedules
- Subject, male or female, between the ages of 4 to 11 yrs
- Female subjects 8 yrs or older will have a negative serum pregnancy test
- Must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
- Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 mos. prior to study start
- Must be in good health with the exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
- Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc
- Subject's p/l guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and questionnaire completion, and demonstrate how to use the MiniWright PEF meter
Who cannot join
- Female subject who is pregnant or lactating
- Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial
- Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
- Have travel commitments during the study that would interfere with trial measurements or compliance or both
- Have a history of hospitalization for asthma within 60 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial
- Have a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations
Show all 15Show fewer
- Subject using any prescription drug with which albuterol sulfate administration is contraindicated
- Have currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 mos. prior to study start
- Have a history of cancer
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication or that may interfere with the successful completion of this protocol
- Have a history of substance abuse or drug abuse within 12 months preceding V1 or a positive urine drug screening at study start
- Have a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
- Has suffered from a clinically significant upper or lower respiratory tract infection in the 2 wks prior to study start
- Have a history of cigarette smoking or use of any tobacco products
- Subject who is a relative of a staff member
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, 87131
Regional Allergy & Asthma Consultants, PA
Asheville, North Carolina, 28801
The Pediatric Clinic
Bogalusa, Louisiana, 70429
Radiant Research
Bridgeton, Missouri, 63044
PI- Coor Clinical Research, LLC
Burke, Virginia, 22015
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, 45245
University Hospitals of Cleveland, Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Asthma & Allergy Associates
Colorado Springs, Colorado, 80907
Integrated Research Group
Corona, California, 92879
Pediatric Allergy/Immunology Associates
Dallas, Texas, 75230
National Jewish Medical & Research Center
Denver, Colorado, 80206
North Texas Institute for Clinical Trials
Fort Worth, Texas, 76132
Allergy & Asthma Associates
Houston, Texas, 77054
Breath of Life Research Institute
Houston, Texas, 77084
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647
Pulmonary Associates of Mobile, PC
Ithaca, New York, 14850
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, 72401
Allergy & Asthma Associates
Kirkland, Washington, 98034
Allergy, Asthma & Sinus Center, PC
Knoxville, Tennessee, 37922
Allergy & Asthma and Dermatology Research Center
Lake Oswego, Oregon, 97035
The Allergy & Asthma Clinical Research Center
Lawrenceville, Georgia, 30045
Essex-Morris Pediatric Group
Livingston, New Jersey, 07960
Asthma, Allergy & Respiratory Care Center
Long Beach, California, 90808
Department of Pediatric Critical Care, Kosair Children's Hospital
Louisville, Kentucky, 40202
Madera Family Medical Group
Madera, California, 93637
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504
Southern California Research
Mission Viejo, California, 92692
Adolescent & Pediatric Associates, PC
Montgomery, Alabama, 36116
Allergy & Asthma Consultants
Mt. Pleasant, South Carolina, 29464
Vanderbilt University ASAP Research
Nashville, Tennessee, 37203
Doctor's Care
New Orleans, Louisiana, 70122
Dolby Providers, Inc
New Orleans, Louisiana, 70127
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology
Orange, California, 92868
Clinical Trials of Orange County
Orange, California, 92868
Bellevue Pediatric Association
Pittsburgh, Pennsylvania, 15202
Allergy Associates Research Center
Portland, Oregon, 97213
Princeton Center for Clinical Research
Princeton, New Jersey, 08540
Sun Research Institute
San Antonio, Texas, 78205
Allergy Associates Medical Group
San Diego, California, 92120
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, 31406
West Coast Clinical Trials, Inc.
Signal Hill, California, 90755
Summit Pediatric Pulmonology
Summit, New Jersey, 07901
Dr. Senders & Associates
University Heights, Ohio, 44118
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, 94598
About this study
Official title: An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
Read the detailed description
This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET. 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 tartrate MDI, racemic albuterol MDI, Placebo
- Keywords
- levalbuterol, pediatric, 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 tartrate MDIDrug
Also called Xopenex MDI
levalbuterol MDI 90 mcg QID
racemic albuterol MDIDrug
racemic albuterol MDI 180 mcg QID
PlaceboDrug
Placebo MDI QID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | levalbuterol MDI 90 mcg QID Receives: Drug: Levalbuterol tartrate MDI |
| 2 | Active comparator | racemic albuterol MDI 190 mcg QID Receives: Drug: racemic albuterol MDI |
| 3 | Placebo comparator | Placebo MDI QID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
was peak percent change in FEV1 from visit predose averaged over the double-blind period
Measured: Week 0, 2, 4
Secondary outcomes (12)
under the FEV1 percent change from visit predose curve averaged over the double-blind period
Measured: Week 0, 2, 4
peak change and peak percent change in FEV1 from visit predose to each visit
Measured: Week 0, 2, 4
peak change in FEV1 from visit predose to each visit
Measured: Week 0, 2, 4
peak percent change in FEV1 from study baseline over the double blind period
Measured: Week 0, 2, 4
time to peak change
Measured: Week 0, 2, 4
peak percent of predicted FEV1 at each visit and over the double-blind period
Measured: Week 0, 2, 4
area under the FEV1 percent change from predose curve at each visit
Measured: Week 0, 2, 4
area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period
Measured: Week 0, 2, 4
percent of predicted FEV1 AUC at each visit
Measured: Week 0, 2, 4
percent change in predose FEV1 from study baseline at each visit
Measured: Week 0, 2, 4
number and percent of responders
Measured: Week 0, 2, 4
time to onset of response and duration of response
Measured: Week 0, 2, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2003 (estimated)
- Study startDec 2002
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 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
- NCT00073814
- Sponsor's protocol ID
- 051-354
- Status last verified
- Feb 2012
- First submitted
- 9 Dec 2003
- 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
- An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00073814
- Acronym / sponsor ID
- 051-354
- Conditions
- Asthma
- Keywords
- levalbuterol, pediatric, asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 10 Dec 2003 (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.
Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
Detailed description
This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET. 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levalbuterol tartrate MDIlevalbuterol MDI 90 mcg QID |
| 2 | Active comparator | Drug: racemic albuterol MDIracemic albuterol MDI 190 mcg QID |
| 3 | Placebo comparator | Drug: PlaceboPlacebo MDI QID |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subject and subject's p/l guardian must be willing and able to comply with the study procedures and visit schedules
- Subject, male or female, between the ages of 4 to 11 yrs
- Female subjects 8 yrs or older will have a negative serum pregnancy test
- Must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
- Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 mos. prior to study start
Key exclusion criteria (15 listed)
- Female subject who is pregnant or lactating
- Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial
- Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
- Have travel commitments during the study that would interfere with trial measurements or compliance or both
- Have a history of hospitalization for asthma within 60 days 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 tartrate MDIAlso: Xopenex MDIlevalbuterol MDI 90 mcg QID | Drug | 1 |
| racemic albuterol MDIracemic albuterol MDI 180 mcg QID | Drug | 2 |
| PlaceboPlacebo MDI QID | Drug | 3 |
Primary outcome
was peak percent change in FEV1 from visit predose averaged over the double-blind period
Time frame: Week 0, 2, 4
12 secondary outcomes
under the FEV1 percent change from visit predose curve averaged over the double-blind period
Time frame: Week 0, 2, 4
peak change and peak percent change in FEV1 from visit predose to each visit
Time frame: Week 0, 2, 4
peak change in FEV1 from visit predose to each visit
Time frame: Week 0, 2, 4
peak percent change in FEV1 from study baseline over the double blind period
Time frame: Week 0, 2, 4
time to peak change
Time frame: Week 0, 2, 4
peak percent of predicted FEV1 at each visit and over the double-blind period
Time frame: Week 0, 2, 4
area under the FEV1 percent change from predose curve at each visit
Time frame: Week 0, 2, 4
area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period
Time frame: Week 0, 2, 4
percent of predicted FEV1 AUC at each visit
Time frame: Week 0, 2, 4
percent change in predose FEV1 from study baseline at each visit
Time frame: Week 0, 2, 4
number and percent of responders
Time frame: Week 0, 2, 4
time to onset of response and duration of response
Time frame: Week 0, 2, 4
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.
45 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 tartrate MDI and racemic albuterol MDI in people with Asthma, run by Sumitomo Pharma America, Inc. at 45 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 8 inclusion and 15 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 45 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. 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?
was peak percent change in FEV1 from visit predose averaged over the double-blind period (time frame: Week 0, 2, 4). 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.