Beta Blocker Therapy in Mild to Moderate Asthmatics (ANDA1)

University of Dundee

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Qvar 50; Drug: Propranolol; Drug: Qvar 100

Study type: Interventional

Funder types: Other

Identifiers

NCT01544634

2011-002512-89 (EudraCT Number)

2011RC16

Details and patient eligibility

About

Current asthma medicines include inhalers. A common type of inhaler is called a 'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the airway causing it to widen. Although these drugs are useful short term, long term use can make asthma worse in some people.

'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in patients with asthma. Beta-blockers cause problems in asthmatics in the short term, including severe asthma attacks.

The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer' medication. These work by dampening down the inflammation in the lungs that occurs in asthma.

New research has suggested that longer term use of beta-blockers can also reduce airway inflammation which may improve asthma control. This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. At the moment the investigators are studying to see if there is a benefit of beta-blocker use for asthma over and above asthmatics own usual doses of inhaled steroids.

In this study, the investigators will be trying to find out if adding a beta blocker to a smaller dose of steroid inhaler has the same effect on asthma control as just using a higher dose of steroid inhaler by itself.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable mild to moderate asthma
• Histamine PC20 </= 8mg/ml
• Receiving inhaled corticosteroid 0-1000ug daily (BDP equivalent dose)
• FEV1 > 60% predicted
• Diurnal variability < 30%
• Reliever use </= 8puffs/day
• ECG demonstrating sinus rhythm

Exclusion criteria

• Uncontrolled symptoms of asthma
• Systolic BP<110mmHg
• Heart rate<60bpm
• Pregnancy or lactation
• Heart block
• Heart rate limiting medications currently prescribed
• Asthma exacerbation within 6 months of study commencement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

Propranolol + Low dose Qvar

Experimental group

Treatment:

Drug: Propranolol

Drug: Qvar 50

Placebo + high dose Qvar

Active Comparator group

Treatment:

Drug: Placebo

Drug: Qvar 100