Beta Blocker Therapy in Mild to Moderate Asthmatics

• Conditions: Asthma; MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-002512-89-GB
• Lead Sponsor: Tayside Clinical Trials Unit, University of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-20
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male and female volunteers age 18-65 with stable mild to moderate asthma. Histamine PC20 <8mg/ml. Steroid naïve or receiving inhaled steroid up to 1000µg/day BDP equivalent dose +/- long acting beta agonist(LABA) or leukotriene receptor antagonist. Stable defined as: FEV1 >60% predicted; diurnal FEV1 variability <30% when LABA washed out; reliever use =8puffs/day.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified