Reversibility of Acute ß-Blocker Induced Bronchoconstriction - SHO001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016592-29-GB

Enrollment

Registered

2010-03-17

Start date

2010-03-05

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma

Interventions

Trade Name: Solu-Cortef Product Name: Solu-cortef Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Hydrocortisone Succinate CAS Number: 50-23-7 Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Informed consent and ability to perform spirometry, IOS, bronchial challenge and all domiciliary measurements. Mild to Moderate Asthmatics taking =1000µg BDP per day or equivalent. 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. Exacerbation in past 6 months. Resting BP<110 systolic or HR<60. Pregnancy or lactation. Known or suspected sensitivity to IMP. Inability to comply with protocol. Any degree of heart block. Rate limiting medication including ß blockers, rate limiting Calcium Channel Blockers, and Amiodarone.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: None;Primary end point(s): Change in FEV1 (ml) post salbutamol post histamine challenge.;Main Objective: To establish whether acute ß-blockade influences the ability to achieve airway reversibility and recovery with systemic corticosteroids and nebulised bronchodilators following histamine challenge in mild to moderate asthmatics.	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026