Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Ventolin
Product Name: Ventolin
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: salbutamol
CAS Number: 35763-26-9
Current Sponsor code: NAI007
Concentration unit: µg
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Persistent stable asthmatics (FEV1 > 60%) on less than or equal to 2000 micrograms BDP or equivalent. 2.Methacholine responsive PC20 =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 less than or equal to 60% or PEF variability >30% or with continual daytime or nocturnal symptoms. 2. The use of oral corticosteroids within the preceding 3 months. 3. Recent respiratory tract infection (within preceding 2 months). 4. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary TB. 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 IMPs. 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: The principle objective of this study is to compare the bronchoprotection (protection against airway muscle spasm) offered by levosalbutamol and normal (racemic) salbutamol at peak (maximum) dose.;Secondary Objective: 1) We plan to examine how the different beta-2 receptor genotypes affect the bronchoprotection seen with both levosalbutamol and salbutamol. 2) We will also look at other measures of bronchodilatation using different breathing tests (spirometry). 3) We will measure the amount of beta-2 receptors on the participants' white cells, in order to gage the degree of receptor downregulation seen with both types of salbutamol (Bmax and Emax) 4) We will measure the maximal amount of salbutamol in the blood (Cmax) and the amount of time it takes to reach this (Tmax), and see if this varies between both preparations. 4) We will ask participants to fill in a symptom and peak flow diary to see how both inhalers affect symptoms.;Primary end point(s): The primary endpoint is the bronchoprotection to methacholine determined as a doubling dilution change from baseline of log2 PC20 performed 30 minutes after a single and chronic doses of racemic salbutamol, levosalbutamol and placebo in asthmatic subjects. | — |
Countries
United Kingdom
Outcome results
None listed