Examination of the Bronchoprotective Effect of Endothelin Receptor Blockade in Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study will be to determine if blockade of endothelin 1 signalling via endothelin receptor A using ambrisentan or dual blockade (A\&B) via bosentan can provide protection against methacholine induced bronchoconstriction in asthma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease

NCT00440245

Asthma COPD

COMPLETED PHASE4

The Effect of Benralizumab on Exercise-induced Bronchoconstriction

NCT03327701

Asthma, Exercise-Induced

UNKNOWN PHASE3

Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

NCT00831376

Asthma

COMPLETED PHASE4

Reversibility of Methacholine Induced Bronchoconstriction

NCT05977699

Asthma

ACTIVE_NOT_RECRUITING PHASE4

Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

NCT01449162

Asthma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Endothelin 1 may have a role in the development of acute airway narrowing in asthma. Blockade of the endothelin system may thereby protect against airway narrowing. Two receptors exist for endothelin 1, Endothelin A \& B. Both can be blocked by Bosentan, and the A receptor by ambrisentan. Both medications are currently in use for the treatment of pulmonary arterial hypertension. The investigators will endeavour to examine the potential role of endothelin 1 in the development of airway narrowing in asthma through blockade of the endothelin receptors A\&B through the use of bosentan and ambrisentan.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ambrisentan

5mg od ambrisentan

Group Type EXPERIMENTAL

Ambrisentan

Intervention Type DRUG

5mg od two weeks

Bosentan

62.5mg bosentan

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

62.5mg bd two weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

bd for two weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ambrisentan

5mg od two weeks

Intervention Type DRUG

Bosentan

62.5mg bd two weeks

Intervention Type DRUG

Placebo

bd for two weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Volibris Tracleer

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Physician diagnosis of asthma confirmed objectively by airway hyperactivity to methacholine (as determined by a ≥ 20% drop in FEV at a methacholine dose of ≤ 8mg/ml after β-agonist withdrawal as per ATS guidelines)
2. Age range 18-60 years
3. FEV1 ≥ 60% predicted
4. Duration of asthma \> 6 months and on stable medication for 4 weeks
5. Prescribed and compliant with inhaled corticosteroid up to a maximum of 2000mcg beclomethasone or equivalent
6. No history of previous regular smoking and current non-smoker

Exclusion Criteria

1. Unstable asthma; defined as the presence of 1 or more of the following events in the month prior to study \[Emergency/'out of hours' visit to GP for asthma exacerbation; GP visit to patient at home for asthma exacerbation or A \& E/hospital admission for asthma exacerbation\]
2. Treatment with oral corticosteroids in the past month
3. Need for maintenance oral corticosteroid therapy
4. Pregnancy or planning to become pregnant over course of study and up to one month after
5. Excessive risk of hepatotoxicity from endothelin receptor antagonists;

* Alcohol excess (defined as regular consumption above government daily recommend limits; currently defined as 28 units per wk for men, 21 units per week for women)
* Previous intravenous drug use
* Current or known history of liver disease (with the exception of Gilberts disease and gallstones)
* Chronic hepatitis (either viral (e.g. hepatitis B or C) or autoimmune)
* Bilirubin, alanine aminotransferase (ALT) or asparate aminotransferase (AST) greater than the upper limit of normal at screening
6. Anaemia (defined as haemoglobin below the lower reference range for sex) at screening
7. Renal failure (defined as eGFR less than 50 mL/minute/1.73 m2) at screening
8. Known HIV positivity
9. History of inability to tolerate bosentan or ambrisentan
10. Significant medical conditions other than asthma felt by investigator to preclude participation in study. This could be either in patients best interest or due to potential to significantly alter responses to medication and hence alter power of clinical trial (examples include; significant heart failure (NYHA grades II-IV), diabetes mellitus, bronchiectasis or haematological malignancy).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No