- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00831376
Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol (NAI009)
April 10, 2019 updated by: Brian J Lipworth, University of Dundee
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Angus
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Dundee, Angus, United Kingdom, DD1 9SY
- Asthma and Allergy Research Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: levosalbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
|
Patients will be asked to take two puffs four times a day for 2 weeks
|
Active Comparator: 2: racemic salbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
|
Patients will be asked to take two puffs four times a day for 2 weeks
Other Names:
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Placebo Comparator: 3: Placebo
Patients will be asked to take two puffs four times a day for 2 weeks
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Patients will be asked to take two puffs four times a day for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
methacholine challenge
Time Frame: before and after 2 week study period
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before and after 2 week study period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
spirometry
Time Frame: before and after 2 week study period
|
before and after 2 week study period
|
nitric oxide levels
Time Frame: before and after 2 week study period
|
before and after 2 week study period
|
symptom scores
Time Frame: before and after 2 week study period
|
before and after 2 week study period
|
Bmax and Emax
Time Frame: before and after 2 week study period
|
before and after 2 week study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karine L Clearie, MBBS, MRCP, Asthma and Allergy Research Group
- Study Director: Brian J Lipworth, MBchB, Asthma and Allergy Research Group
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
January 27, 2009
First Submitted That Met QC Criteria
January 27, 2009
First Posted (Estimate)
January 28, 2009
Study Record Updates
Last Update Posted (Actual)
April 12, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
Other Study ID Numbers
- NAI009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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