Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol (NAI007)
This study has been withdrawn prior to enrollment.
(Lack of funding)
Sponsor:
University of Dundee
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier:
NCT00830882
First received: January 27, 2009
Last updated: June 11, 2012
Last verified: June 2012
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Purpose
The objective of this study is to compare the peak dose relative bronchoprotection offered by levosalbutamol and racemic salbutamol in mild to moderate asthmatics preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: levosalbutamol Drug: racemic salbutamol Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Proof of Concept Study to Evaluate the Peak Bronchoprotection Conferred by Single and Chronic Dosing With Levosalbutamol and Racemic Salbutamol in Persistent Asthmatics. |
Resource links provided by NLM:
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
U.S. FDA Resources
Further study details as provided by University of Dundee:
Primary Outcome Measures:
- Methacholine challenge [ Time Frame: Before and 30 mins after drug administration, and after 2 weeks of chronic treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Salbutamol pharmacokinetics [ Time Frame: over 30 minutes after drug administration, one day 1 and 14 of a 2 week study period ] [ Designated as safety issue: No ]
- Spirometry [ Time Frame: before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing ] [ Designated as safety issue: No ]
- potassium [ Time Frame: before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1:levosalbutamol
2 puffs four times a day for 2 weeks
|
Drug: levosalbutamol
2 puffs four times a day for 2 weeks
Other Name: levosalbutamol
|
|
Active Comparator: 2: racemic salbutamol
2 puffs four times a day for 2 weeks
|
Drug: racemic salbutamol
2 puffs four times a day for 2 weeks
Other Name: ventolin
|
|
Placebo Comparator: 3: Placebo
2 puffs four times a day for 2 weeks
|
Drug: placebo
2 puffs four times a day for 2 weeks
Other Name: placebo to salbutamol
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830882
Locations
| United Kingdom | |
| Asthma and Allergy Research Group | |
| Dundee, Angus, United Kingdom, DD1 9SY | |
Sponsors and Collaborators
University of Dundee
Investigators
| Principal Investigator: | Karine L Clearie, MBBS, MRCP | Asthma and Allergy Research Group |
| Study Director: | Brian J Lipworth, MBchB | Asthma and Allergy Research Group |
More Information
No publications provided
| Responsible Party: | Brian J Lipworth, Professor, University of Dundee |
| ClinicalTrials.gov Identifier: | NCT00830882 History of Changes |
| Other Study ID Numbers: | NAI007 |
| Study First Received: | January 27, 2009 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Dundee:
|
asthma levosalbutamol genotype bronchoprotection |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on October 18, 2012
