AsthmaPhase 2NCT01656811
A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
A Phase 2 study testing levalbuterol 90 mcg, levalbuterol 180 mcg and racemic albuterol 180 mcg in people with Asthma, run by Sumitomo Pharma America, Inc..
Trial summary
Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study of up to four weeks in duration. The study consisted of a screening visit followed by a one-week single blind placebo period. 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 90 mcg, levalbuterol 180 mcg and racemic albuterol 180 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Jul 2002
- 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's parent/legal guardian provided written informed consent prior to participation in the study.
- Subject and the subject's parent/legal guardian were willing and able to comply with the study procedures and visit schedules.
- Subject (male or female) was between the ages of 4 to 11 years (inclusive) at the time of consent.
- Female subject 8 years of age or older had a negative serum pregnancy test at screening.
- Subject had a documented diagnosis of asthma for a minimum of 6 months prior to screening, as defined by the AARC.
- Subject demonstrated a baseline FEV1 within greater than or equal to 45% and less than or equal to 80% of predicted for their height, age, gender, and race
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- Following abstention from medications used to treat asthma subject demonstrated greater than or equal to 12% reversibility of airflow obstruction within 15-30 minutes following inhalation of 180 mcg (2 actuations of 90 mcg) racemic albuterol MDI.
- Subject had stable baseline asthma (in the opinion of the Investigator) and had been using a beta-adrenergic agonist and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months prior to screening.
- Subject was in good health (with the exception of asthma) and not suffering from any chronic condition that might affect their respiratory function.
- Subject had a chest x-ray that was not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc. The most recent chest x-ray taken within 12 months prior to randomization was allowed to be used.
- Subject's parent/legal guardian was able to complete 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 to complete morning and evening peak expiratory flow measurements.
Who cannot join
- Subject was expected to require parenteral corticosteroids, adrenergic bronchodilators, non-prescription asthma medications, or ipratropium bromide as per list below:
- Corticosteroids - Parenteral = 30 days wash out period. Adrenergic bronchodilators - Inhaled, short-acting = greater than or equal to 7 hours wash out period, Nebulized, short acting = greater than or equal to 10 hours wash out period, Inhaled, long acting = greater than or equal to 24 hours wash out period, Oral QID or TID preparation =greater than or equal to 24 hours wash out period, Oral BID preparations = greater than or equal to 36 hours wash out period, Nonprescription asthma medications = greater than or equal to 48 hours wash out period, Ipratropium bromide = greater than or equal to 48 hours wash out period (Study medication and rescue medication were allowed to be used as needed but were required to be with-held prior to Study visits according to the schedule noted above)
- Female subject was pregnant or lactating.
- Subject participated in an investigational drug study within 30 days prior to screening, or was currently participating in another clinical trial.
- Subject had a schedule that prevented him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM.
- Subject had travel commitments during the study that would have interfered with trial measurements and/or compliance.
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- Subject had a history of hospitalization for asthma within 60 days prior to screening, or was scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
- Subject had a known sensitivity to levalbuterol or racemic albuterol, including Ventolin or any of the excipients contained in any of these formulations.
- Subject was using any prescription drug with which albuterol sulfate administration was contraindicated
- Subject was currently diagnosed with life-threatening asthma, defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to screening..
- Subject had clinically significant abnormalities that may have interfered with the metabolism or excretion of the study drug (e.g., abnormalities of the renal, hepatic, metabolic, or endocrine function).
- Subject had a history of cancer.
- Subject had hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders that were not well controlled by medication or that may have interfered with the successful completion of this protocol.
- Subject had a history of substance abuse or drug abuse within 12 months prior to screening.
- Subject had a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
- Subject suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to screening. (Note: Any subject who developed a clinically significant respiratory tract infection during the study was required to be discontinued.)
- Subject had clinically significant abnormal laboratory values (hematology, blood chemistry, or urinalysis).
- Subject had a clinically significant abnormal 12-lead ECG that would have put the subject at risk for experiencing adverse cardiac events.
- Subject had a history of cigarette smoking or use of other tobacco products.
- Subject was a staff member or a relative of a staff member at the time of the study.
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
Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study of up to four weeks in duration. The study consisted of a screening visit followed by a one-week single blind placebo period. At next visit, each subject was randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180 mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4 times a day for 21 days.
Read the detailed description
This was a multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study up to four weeks in duration. Seven days of QID (four times a day) single-blind, placebo administration (via metered dose inhaler (MDI)) was followed by 21 days of QID double-blind treatment. During the single-blind period, rescue medication consisted of racemic albuterol MDI (90 mcg per actuation) for all subjects. During the double-blind period, rescue medication consisted of double-blind levalbuterol MDI (45 mcg per actuation) for all subjects in the levalbuterol treatment groups or double-blind racemic albuterol MDI (90 mcg per actuation) for all subjects in the racemic albuterol and placebo treatment groups.The study consisted of two periods, an optional follow-up visit, and a final telephone evaluation. This study was previously conducted 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 90 mcg, levalbuterol 180 mcg, racemic albuterol 180 mcg, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levalbuterol 90 mcgDrug
90 mcg levalbuterol delivered via MDI 2 actuations of 45 mcg QID
levalbuterol 180 mcgDrug
180 mcg levalbuterol delivered via MDI 2 actuations of 90 mcg QID
racemic albuterol 180 mcgDrug
180 mcg racemic albuterol delivered via MDI 2 actuations of 90 mcg QID
PlaceboDrug
Placebo 2 actuations QID
| Study group | Role | What they receive |
|---|---|---|
| levalbuterol 90 mcg | Experimental | levalbuterol 90 mcg delivered via metered dose inhaler (MDI) Receives: Drug: levalbuterol 90 mcg |
| levalbuterol 180 mcg | Experimental | levalbuterol 180 mcg delivered via MDI Receives: Drug: levalbuterol 180 mcg |
| racemic albuterol 180 mcg | Active comparator | racemic albuterol 180 mcg delivered via MDI Receives: Drug: racemic albuterol 180 mcg |
| Placebo | Placebo comparator | Placebo delivered via MDI Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak percent change in FEV1 (forced expiratory volume in one second) from visit predose averaged over the double-blind period to investigate the efficacy of levalbuterol versus racemic albuterol
Measured: Week 0-4
Secondary outcomes (2)
Plasma concentrations of (R)-albuterol and (S)-albuterol over time to determine the pharmacokinetics of levalbuterol in pediatric subjects with asthma
Measured: Week 0-4
Number of AEs to compare the safety and tolerability of two different doses of levalbuterol
Measured: Week 0-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startOct 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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xopenex Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656811
- Sponsor's protocol ID
- 051-306
- Status last verified
- Jul 2012
- First submitted
- 30 Jul 2012
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 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
- NCT01656811
- Acronym / sponsor ID
- 051-306
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Jul 2002 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 3 Aug 2012 (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.
Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study of up to four weeks in duration. The study consisted of a screening visit followed by a one-week single blind placebo period. At next visit, each subject was randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180 mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4 times a day for 21 days.
Detailed description
This was a multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study up to four weeks in duration. Seven days of QID (four times a day) single-blind, placebo administration (via metered dose inhaler (MDI)) was followed by 21 days of QID double-blind treatment. During the single-blind period, rescue medication consisted of racemic albuterol MDI (90 mcg per actuation) for all subjects. During the double-blind period, rescue medication consisted of double-blind levalbuterol MDI (45 mcg per actuation) for all subjects in the levalbuterol treatment groups or double-blind racemic albuterol MDI (90 mcg per actuation) for all subjects in the racemic albuterol and placebo treatment groups.The study consisted of two periods, an optional follow-up visit, and a final telephone evaluation. This study was previously conducted 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| levalbuterol 90 mcg | Experimental | Drug: levalbuterol 90 mcglevalbuterol 90 mcg delivered via metered dose inhaler (MDI) |
| levalbuterol 180 mcg | Experimental | Drug: levalbuterol 180 mcglevalbuterol 180 mcg delivered via MDI |
| racemic albuterol 180 mcg | Active comparator | Drug: racemic albuterol 180 mcgracemic albuterol 180 mcg delivered via MDI |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo delivered via MDI |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Subject's parent/legal guardian provided written informed consent prior to participation in the study.
- Subject and the subject's parent/legal guardian were willing and able to comply with the study procedures and visit schedules.
- Subject (male or female) was between the ages of 4 to 11 years (inclusive) at the time of consent.
- Female subject 8 years of age or older had a negative serum pregnancy test at screening.
- Subject had a documented diagnosis of asthma for a minimum of 6 months prior to screening, as defined by the AARC.
Key exclusion criteria (20 listed)
- Subject was expected to require parenteral corticosteroids, adrenergic bronchodilators, non-prescription asthma medications, or ipratropium bromide as per list below:
- Corticosteroids - Parenteral = 30 days wash out period. Adrenergic bronchodilators - Inhaled, short-acting = greater than or equal to 7 hours wash out period, Nebulized, short acting = greater than or equal to 10 hours wash out period, Inhaled, long acting = greater than or equal to 24 hours wash out period, Oral QID or TID preparation =greater than or equal to 24 hours wash out period, Oral BID preparations = greater than or equal to 36 hours wash out period, Nonprescription asthma medications = greater than or equal to 48 hours wash out period, Ipratropium bromide = greater than or equal to 48 hours wash out period (Study medication and rescue medication were allowed to be used as needed but were required to be with-held prior to Study visits according to the schedule noted above)
- Female subject was pregnant or lactating.
- Subject participated in an investigational drug study within 30 days prior to screening, or was currently participating in another clinical trial.
- Subject had a schedule that prevented him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM.
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 90 mcg90 mcg levalbuterol delivered via MDI 2 actuations of 45 mcg QID | Drug | levalbuterol 90 mcg |
| levalbuterol 180 mcg180 mcg levalbuterol delivered via MDI 2 actuations of 90 mcg QID | Drug | levalbuterol 180 mcg |
| racemic albuterol 180 mcg180 mcg racemic albuterol delivered via MDI 2 actuations of 90 mcg QID | Drug | racemic albuterol 180 mcg |
| PlaceboPlacebo 2 actuations QID | Drug | Placebo |
Primary outcome
Peak percent change in FEV1 (forced expiratory volume in one second) from visit predose averaged over the double-blind period to investigate the efficacy of levalbuterol versus racemic albuterol
Time frame: Week 0-4
2 secondary outcomes
Plasma concentrations of (R)-albuterol and (S)-albuterol over time to determine the pharmacokinetics of levalbuterol in pediatric subjects with asthma
Time frame: Week 0-4
Number of AEs to compare the safety and tolerability of two different doses of levalbuterol
Time frame: Week 0-4
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 3 Aug 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.
Xopenex Medical Director, MD study director
Sumitomo Pharma America, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levalbuterol 90 mcg, levalbuterol 180 mcg and racemic albuterol 180 mcg in people with Asthma, run by Sumitomo Pharma America, Inc..
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 11 inclusion and 20 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 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Peak percent change in FEV1 (forced expiratory volume in one second) from visit predose averaged over the double-blind period to investigate the efficacy of levalbuterol versus racemic albuterol (time frame: Week 0-4). 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 3 Aug 2012.