Asthma MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Propranolol 10mg
Product Name: Propranolol 10mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Propranolol hydrochloride
CAS Number: 318-98-9
Concentration unit: mg milligram(s)
Concent
Sponsors
Tayside Clinical Trials Unit, University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female volunteers age 18-65 with stable mild to moderate asthma. Histamine PC20 60% predicted; diurnal FEV1 variability =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Uncontrolled symptoms of asthma; Resting systolic BP<110mmHg or resting HR<60bpm; Pregnancy or lactation; Known or suspected sensitivity to IMP; Inability to comply with protocol; Any degree of heart block; Rate-limiting medication including beta blockers, rate-limiting Calcium Channel Blockers and Amiodarone; Any clinically significant medical condition that may endanger the health or safety of the participant, or jeopardise the protocol; An asthma exacerbation requiring systemic steroids within 6 months of study commencement; Has not participated in another study in the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do any effects on airway 'twitchiness' in asthma with chronic dosing of beta blockers and low dose steroid inhaler differ with being on a high dose steroid inhaler?;Secondary Objective: None;Primary end point(s): To evaluate any steroid-sparing effect of concomitant chronic dosing with beta blockers with low dose ICS on airway hyper-reactivity in stable mild to moderate asthmatics compared to high dose ICS alone.;Timepoint(s) of evaluation of this end point: Histamine bronchial challenge will be performed at baseline and at the end of each of the two treatment periods i.e. at visits 1, 3 and 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Impulse Oscillometry; FEV1; salbutamol recovery post histamine challenge; serum BDNF and ECP; Heart Rate and Serum potassium pre and post histamine challenge; Blood pressure; FeNO; Overnight urinary cortisol/creatinine ratio (OUCC); AQLQ; ACQ; Domiciliary FEV1, symptoms and reliever use.;Timepoint(s) of evaluation of this end point: Domiciliary FEV1, symptoms and reliever use will be performed daily by the patient at home throughout the study. Impulse Oscillometry; FEV1; salbutamol recovery post histamine challenge; serum BDNF and ECP; Heart Rate and Serum potassium pre and post histamine challenge; Blood pressure; FeNO; OUCC; AQLQ and ACQ will be performed at baseline and at the end of each of the three treatment periods i.e. at visits 1, 3, and 5. | — |
Countries
United Kingdom
Contacts
Public ContactAsthma & Allergy Research Group
University of Dundee
Outcome results
None listed