asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Propranolol
Product Name: Propranolol
Pharmaceutical Form: Capsule*
INN or Proposed INN: PROPRANOLOL HYDROCHLORIDE
CAS Number: 318-98-9
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female volunteers with stable mild intermittent or mild persistent asthma. Stable defined as: FEV1 >80% predicted with diurnal FEV1 variation =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Uncontrolled symptoms of asthma. Resting BP<110 systolic or HR<60. Pregnancy or lactation. Known or suspected sensitivity to the IMP(s). Inability to comply with protocol. Any degree of heart block. Rate limiting medication including ß blockers, rate limiting Calcium Channel Blockers and Amiodarone. Any other clinically significant medical condition that may either endanger the health or safety of the participant, or jeopardise the protocol. An asthma exacerbation within the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether chronic dosing with beta-blockers reduces airway inflammation in mild-to-moderate asthmatics on inhaled corticosteriods.;Secondary Objective: ;Primary end point(s): Primary endpoint: Change in methacholine PC20. Secondary endpoints: Change in Histamine PC20, AUC for recovery post methacholine and histamine challenge, Full Spirometry, Impulse Oscillometry (IOS), Serum K+, brain derived neurotrophic factor (BDNF), eosinophil derived neurotoxin (EDN), Eosinophil Cationic Protein (ECP), Cyclic adenosine monophosphate (cAMP), beta-2 genotyping, beta blocker assays, Blood Pressure and Heart Rate. | — |
Countries
United Kingdom
Outcome results
None listed