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Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol (NAI009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier:
NCT00831376
First received: January 27, 2009
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


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 Trough Bronchoprotection Conferred by Chronic Dosing With Levosalbutamol and Racemic Salbutamol in Persistent Asthmatics

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • methacholine challenge [ Time Frame: before and after 2 week study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • spirometry [ Time Frame: before and after 2 week study period ] [ Designated as safety issue: No ]
  • nitric oxide levels [ Time Frame: before and after 2 week study period ] [ Designated as safety issue: No ]
  • symptom scores [ Time Frame: before and after 2 week study period ] [ Designated as safety issue: No ]
  • Bmax and Emax [ Time Frame: before and after 2 week study period ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: levosalbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
 Drug: levosalbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
Other Name: Levosalbutamol
Active Comparator: 2: racemic salbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
 Drug: racemic salbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
Other Name: Ventolin
Placebo Comparator: 3: Placebo
Patients will be asked to take two puffs four times a day for 2 weeks
 Drug: placebo
Patients will be asked to take two puffs four times a day for 2 weeks
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent, who are methacholine responsive PC20< 4 mg/ml
  2. >1dd change in methacholine PC20 after the administration of racemic Salbutamol.
  3. Male or female 18-65
  4. Informed Consent
  5. Ability to comply with the requirements of the protocol

Exclusion Criteria:

  1. Severe asthmatics as defined by an FEV1≤ 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms.
  2. The use of oral corticosteroids within the last 3 months.
  3. Recent respiratory tract infection (2 months).
  4. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
  5. 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.
  6. Any significant abnormal laboratory result as deemed by the investigators
  7. Pregnancy, planned pregnancy or lactation
  8. Known or suspected contra-indication to any of the IMP's
  9. 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: NCT00831376

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Brian J Lipworth, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT00831376     History of Changes
Other Study ID Numbers: NAI009
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
Genotype
Beta2adrenoreceptor
Levosalbutamol

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 May 19, 2013