asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: LEVOLIN
Product Code: LEVOLIN
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: Levosalbutamol tartrate
CAS Number: 34391-04-3
Current Sponsor code: NAI009
Concentrat
Sponsors
The University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Mild to moderate stable asthmatics on = 2000µg BDP or equivalent, who are methacholine responsive PC201dd 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the degree that levosalbutamol and normal (racemic) salbutamol protect the airway against the effects of methacholine (irrespective of the participant's beta receptor genotype).;Secondary Objective: We plan to examine how the different types of beta-2 receptor genotype affect the bronchoprotection seen with both levosalbutamol and salbutamol. We will also look at other measures of bronchodilatation using different breathing tests (spirometry) We will measure the amount of beta-2 receptors on the participants' white cells, in order to gauge the level of receptor down-regulation seen with both types of salbutamol (Bmax and Emax) We will measure participant's nitric oxide levels to see how this differs between the treatment groups. We will compare asthma symptom and peak flow charts, to determine change in symptoms at baseline and following two weeks chronic dosing with each of the three treatments.;Primary end point(s): The primary endpoint is the bronchoprotection to methacholine, determined as a doubling dilution change from baseline of log2 PC20 performed 6hrs after the first and last doses (after 2 weeks of treatment) with racemic/ levosalbutamol/ placebo in asthmatic patients. | — |
Countries
United Kingdom
Outcome results
None listed