AsthmaPhase 4NAI009NCT00831376
Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol
A Phase 4 study testing levosalbutamol and racemic salbutamol in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patients will be preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- levosalbutamol and racemic salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Apr 2012
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent, who are methacholine responsive PC20< 4 mg/ml
- >1dd change in methacholine PC20 after the administration of racemic Salbutamol.
- Male or female 18-65
- Informed Consent
- Ability to comply with the requirements of the protocol
Who cannot join
- Severe asthmatics as defined by an FEV1≤ 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms.
- The use of oral corticosteroids within the last 3 months.
- Recent respiratory tract infection (2 months).
- Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
- Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA, that may endanger the health or safety of the participant, or jeopardise the protocol.
- Any significant abnormal laboratory result as deemed by the investigators
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- Pregnancy, planned pregnancy or lactation
- Known or suspected contra-indication to any of the IMP's
- Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Asthma and Allergy Research Group
Dundee, Angus, DD1 9SY
About this study
Official title: A Proof of Concept Study to Evaluate the Trough Bronchoprotection Conferred by Chronic Dosing With Levosalbutamol and Racemic Salbutamol in Persistent Asthmatics
The objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patients will be preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a differential effect on the bronchoprotection conferred by both formulations of salbutamol, as evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any effect can be explained by the S enantiomer in the racemic formulation.
- Conditions
- Asthma
- Being tested
- levosalbutamol, racemic salbutamol, placebo
- Keywords
- Asthma, Genotype, Beta2adrenoreceptor, Levosalbutamol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosalbutamolDrug
Patients will be asked to take two puffs four times a day for 2 weeks
racemic salbutamolDrug
Also called Ventolin
Patients will be asked to take two puffs four times a day for 2 weeks
placeboDrug
Patients will be asked to take two puffs four times a day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| levosalbutamol | Experimental | Patients will be asked to take two puffs four times a day for 2 weeks Receives: Drug: levosalbutamol |
| 2: racemic salbutamol | Active comparator | Patients will be asked to take two puffs four times a day for 2 weeks Receives: Drug: racemic salbutamol |
| 3: Placebo | Placebo comparator | Patients will be asked to take two puffs four times a day for 2 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
methacholine challenge
Measured: before and after 2 week study period
Secondary outcomes (4)
spirometry
Measured: before and after 2 week study period
nitric oxide levels
Measured: before and after 2 week study period
symptom scores
Measured: before and after 2 week study period
Bmax and Emax
Measured: before and after 2 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian J Lipworth, University of Dundee
- Investigators
- Karine L Clearie, MBBS, MRCP, Principal investigator, Asthma and Allergy Research GroupBrian J Lipworth, MBchB, Study director, Asthma and Allergy Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831376
- Sponsor's protocol ID
- NAI009
- Acronym
- NAI009
- Status last verified
- Apr 2019
- First submitted
- 27 Jan 2009
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson WJ, Short PM, Williamson PA, Morrison AE, Palmer C, Tavendale R, Lipworth BJ. Proof-of-concept evaluation of trough airway hyper-responsiveness following regular racemic or levosalbutamol in genotype-stratified steroid-treated persistent asthmatic patients. Clin Sci (Lond). 2014 Jan 1;126(1):75-83. doi: 10.1042/CS20130213.
PubMed 23829494
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate the Trough Bronchoprotection Conferred by Chronic Dosing With Levosalbutamol and Racemic Salbutamol in Persistent Asthmatics
- ClinicalTrials.gov ID
- NCT00831376
- Acronym / sponsor ID
- NAI009 / NAI009
- Conditions
- Asthma
- Keywords
- Asthma, Genotype, Beta2adrenoreceptor, Levosalbutamol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Jan 2009 (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 objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patients will be preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a differential effect on the bronchoprotection conferred by both formulations of salbutamol, as evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any effect can be explained by the S enantiomer in the racemic formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| levosalbutamol | Experimental | Drug: levosalbutamolPatients will be asked to take two puffs four times a day for 2 weeks |
| 2: racemic salbutamol | Active comparator | Drug: racemic salbutamolPatients will be asked to take two puffs four times a day for 2 weeks |
| 3: Placebo | Placebo comparator | Drug: placeboPatients will be asked to take two puffs four times a day for 2 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent, who are methacholine responsive PC20< 4 mg/ml
- >1dd change in methacholine PC20 after the administration of racemic Salbutamol.
- Male or female 18-65
- Informed Consent
- Ability to comply with the requirements of the protocol
Key exclusion criteria (9 listed)
- Severe asthmatics as defined by an FEV1≤ 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms.
- The use of oral corticosteroids within the last 3 months.
- Recent respiratory tract infection (2 months).
- Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
- Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA, that may endanger the health or safety of the participant, or jeopardise the protocol.
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 |
|---|---|---|
| levosalbutamolPatients will be asked to take two puffs four times a day for 2 weeks | Drug | levosalbutamol |
| racemic salbutamolAlso: VentolinPatients will be asked to take two puffs four times a day for 2 weeks | Drug | 2: racemic salbutamol |
| placeboPatients will be asked to take two puffs four times a day for 2 weeks | Drug | 3: Placebo |
Primary outcome
methacholine challenge
Time frame: before and after 2 week study period
4 secondary outcomes
spirometry
Time frame: before and after 2 week study period
nitric oxide levels
Time frame: before and after 2 week study period
symptom scores
Time frame: before and after 2 week study period
Bmax and Emax
Time frame: before and after 2 week study period
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 12 Apr 2019.
- Results publication: PubMed 23829494Anderson WJ, Short PM, Williamson PA, Morrison AE, Palmer C, Tavendale R, Lipworth BJ. Proof-of-concept evaluation of trough airway hyper-responsiveness following regular racemic or levosalbutamol in genotype-stratified steroid-treated persistent asthmatic patients. Clin Sci (Lond). 2014 Jan 1;126(1):75-83. doi: 10.1042/CS20130213.
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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.
Karine L Clearie, MBBS, MRCP principal investigator
Asthma and Allergy Research Group
Brian J Lipworth, MBchB study director
Asthma and Allergy Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levosalbutamol and racemic salbutamol in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
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 5 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 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
methacholine challenge (time frame: before and after 2 week study period). 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 NCT00831376, which also lists 1 linked publication.
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 12 Apr 2019.