AsthmaPhase 2NCT00320034
Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma
A Phase 2 study testing R-albuterol, S-albuterol in people with Asthma, run by Hamilton Health Sciences Corporation.
Trial summary
The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- R-albuterol, S-albuterol
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Nov 2009
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55.
- Stable, mild atopic asthma with forced expiratory volume in one second (FEV1.0) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta-agonists as needed.
- No recent or significant history of cigarette smoking (no cigarettes within six months prior to entry into the study; less than 10 pack-years cumulative history of cigarette smoking).
- Peak decrease in FEV1 in both early (0-2 hour) and late (3-7 hour) allergen-provoked response of > 15% compared with the baseline (pre-allergen challenge) spirometric determination.
- Signed written informed consent to participate in the protocol; ability to return to the outpatient clinic for repeated clinic visits.
- No history of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a six week period preceding entry into the screening phase of the study.
Who cannot join
- Significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular or other body system disorder.
- History of an acute exacerbation, or of a respiratory tract infection at any time during the past 6 weeks.
- Baseline AST or ALT (indicators of liver damage) greater than twice the upper limit of the normal range for the local laboratory.
- History of allergy or hypersensitivity to short-acting beta-agonists.
- Inability to discontinue asthma medications for the duration of the study or receipt of oral or inhaled corticosteroids or leukotriene receptor antagonist in the three weeks prior to entry into the screening phase of the study.
- Recent (within the past 2 months) or planned (within the study period) lung volume reduction surgery.
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- Psychosis, alcoholism, active substance abuse, or any personality disorder which would make compliance with this protocol problematic.
- Pregnant or nursing females.
- Any other medical or social condition which, in the opinion of the investigator, could confound the interpretation of the data derived from this study.
About this study
Official title: Double-blind, Crossover, Placebo-controlled Evaluation of the Effect of Levalbuterol (R-albuterol) on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma
The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol.
R-albuterol ( levalbuterol) has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients. However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways.
The purpose of this study is to compare the effects of the R- and S- isomers on allergen induced airway inflammation in subjects with mild atopic asthma. This will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.
Read the detailed description
The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol .
R-albuterol ( levalbuterol) relieves the narrowing of the bronchial air passages in the lungs and has been approved by the U.S. FDA, but is not currently licensed for use in Canada. We have obtained approval from Health Canada to use these isomers for the purpose of this study. R-albuterol has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients, with only a few mild to moderate side effects (such as palpitations, diarrhoea, abdominal pain, bodyache, leg cramps and headache). However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways.
The purpose of this study is to determine the effect of this drug, levalbuterol, on the allergen-induced inflammatory response in adult subjects with asthma. Specifically, we want to look for changes in airway eosinophils by examining sputum samples and to compare the effects of the R- and S- isomers on airway inflammation. This will help us to understand whether the racemic albuterol could worsen inflammation because of the presence of the S-isomer, and this will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.
- Conditions
- Asthma
- Being tested
- R-albuterol, S-albuterol
- Keywords
- levalbuterol, asthma, allergen provocation, airway inflammation, clinical trial
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-albuterol, S-albuterolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in airway eosinophil number (% and absolute numbers) following an allergen inhalation.
Secondary outcomes (6)
Changes in:
PC20 methacholine
Allergen-induced early and late asthma responses
Airway eosinophil activation (EG-2+ eosinophils)
Levels of IL-5, RANTES, and eotaxin in sputum
Expression of PLCß1 on airway eosinophils
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Investigators
- Parameswaran Nair, MD, Principal investigator, Firestone Institute for Respiratory Health, St. Joseph's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320034
- Sponsor's protocol ID
- SRC 192
- Status last verified
- Jul 2009
- First submitted
- 27 Apr 2006
- Last updated
- 2 Mar 2011
- Results posted
- No
Publications
Lotvall J, Palmqvist M, Arvidsson P, Maloney A, Ventresca GP, Ward J. The therapeutic ratio of R-albuterol is comparable with that of RS-albuterol in asthmatic patients. J Allergy Clin Immunol. 2001 Nov;108(5):726-31. doi: 10.1067/mai.2001.119152.
PubMed 11692096Handley DA, Tinkelman D, Noonan M, Rollins TE, Snider ME, Caron J. Dose-response evaluation of levalbuterol versus racemic albuterol in patients with asthma. J Asthma. 2000 Jun;37(4):319-27. doi: 10.3109/02770900009055455.
PubMed 10883742
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Crossover, Placebo-controlled Evaluation of the Effect of Levalbuterol (R-albuterol) on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma
- ClinicalTrials.gov ID
- NCT00320034
- Acronym / sponsor ID
- SRC 192
- Conditions
- Asthma
- Keywords
- levalbuterol, asthma, allergen provocation, airway inflammation, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Apr 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Apr 2006 (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 most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol.
R-albuterol ( levalbuterol) has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients. However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways.
The purpose of this study is to compare the effects of the R- and S- isomers on allergen induced airway inflammation in subjects with mild atopic asthma. This will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.
Detailed description
The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol .
R-albuterol ( levalbuterol) relieves the narrowing of the bronchial air passages in the lungs and has been approved by the U.S. FDA, but is not currently licensed for use in Canada. We have obtained approval from Health Canada to use these isomers for the purpose of this study. R-albuterol has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients, with only a few mild to moderate side effects (such as palpitations, diarrhoea, abdominal pain, bodyache, leg cramps and headache). However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways.
The purpose of this study is to determine the effect of this drug, levalbuterol, on the allergen-induced inflammatory response in adult subjects with asthma. Specifically, we want to look for changes in airway eosinophils by examining sputum samples and to compare the effects of the R- and S- isomers on airway inflammation. This will help us to understand whether the racemic albuterol could worsen inflammation because of the presence of the S-isomer, and this will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55.
- Stable, mild atopic asthma with forced expiratory volume in one second (FEV1.0) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta-agonists as needed.
- No recent or significant history of cigarette smoking (no cigarettes within six months prior to entry into the study; less than 10 pack-years cumulative history of cigarette smoking).
- Peak decrease in FEV1 in both early (0-2 hour) and late (3-7 hour) allergen-provoked response of > 15% compared with the baseline (pre-allergen challenge) spirometric determination.
- Signed written informed consent to participate in the protocol; ability to return to the outpatient clinic for repeated clinic visits.
Key exclusion criteria (9 listed)
- Significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular or other body system disorder.
- History of an acute exacerbation, or of a respiratory tract infection at any time during the past 6 weeks.
- Baseline AST or ALT (indicators of liver damage) greater than twice the upper limit of the normal range for the local laboratory.
- History of allergy or hypersensitivity to short-acting beta-agonists.
- Inability to discontinue asthma medications for the duration of the study or receipt of oral or inhaled corticosteroids or leukotriene receptor antagonist in the three weeks prior to entry into the screening phase of the study.
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 |
|---|---|---|
| R-albuterol, S-albuterol | Drug | – |
Primary outcome
The change in airway eosinophil number (% and absolute numbers) following an allergen inhalation.
6 secondary outcomes
Changes in:
PC20 methacholine
Allergen-induced early and late asthma responses
Airway eosinophil activation (EG-2+ eosinophils)
Levels of IL-5, RANTES, and eotaxin in sputum
Expression of PLCß1 on airway eosinophils
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 2 Mar 2011.
- Background: PubMed 11692096Lotvall J, Palmqvist M, Arvidsson P, Maloney A, Ventresca GP, Ward J. The therapeutic ratio of R-albuterol is comparable with that of RS-albuterol in asthmatic patients. J Allergy Clin Immunol. 2001 Nov;108(5):726-31. doi: 10.1067/mai.2001.119152.
- Background: PubMed 10883742Handley DA, Tinkelman D, Noonan M, Rollins TE, Snider ME, Caron J. Dose-response evaluation of levalbuterol versus racemic albuterol in patients with asthma. J Asthma. 2000 Jun;37(4):319-27. doi: 10.3109/02770900009055455.
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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.
Parameswaran Nair, MD principal investigator
Firestone Institute for Respiratory Health, St. Joseph's Healthcare
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-albuterol, S-albuterol in people with Asthma, run by Hamilton Health Sciences Corporation.
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 9 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 2 Mar 2011. 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. 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?
The change in airway eosinophil number (% and absolute numbers) following an allergen inhalation.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00320034, which also lists 2 linked publications.
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 2 Mar 2011.