In Vitro Evaluation of a Novel Drug on Airway Epithelial Cells Obtained From Participants With Severe Asthma

• Status: Completed
• Trial end date: 2016-10-19
• Target enrollment: 0
• Participant gender: All

Summary

Asthma is a long term disease of the lungs. In asthma patients the sensitive airway tubes narrow in reaction to something that irritates the airways such as allergens or environmental pollutants. There is currently no cure for asthma and new medicines or combinations of medicines are needed that will be of benefit to patients particularly those with a more severe disease.

Activation of certain signal molecules inside the lung cells may participate in the development of asthma and the response to allergens. Blocking these signal molecules specifically with medicines might therefore be beneficial in the treatment of asthma. In this study we want to test a new medicine that specifically targets a subset of signal molecules that are associated with the allergen response in the lung. In particular, we want to test this medicine on cells obtained from the lungs of asthma patients. Understanding the effects of this new medicine on these asthmatic lung cells will give vital information on how this new medicine works before we can test it in asthma patients.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborator: Vectura Limited

Criteria

Inclusion Criteria:

All patients must be able to give informed consent.

The definition of severe asthma will be on the basis of:

1. Treatment: High dose of ICS ± OCS ≥ 1000mcg FP daily or equivalent plus one other controller medication.

2. Disease Control: Uncontrolled (GINA guidelines), three or more of the following present in any week in the preceding 4 weeks:

1. Daytime symptoms more than twice per week

2. Any limitation of activities

3. Nocturnal symptoms once or more per week

4. Need for reliever treatment more than twice per week

5. Prebronchodilator FEV1 <80% predicted or personal best AND/OR Frequent severe exacerbations (≥2 per year requiring high dose OCS or doubling of maintenance dose for at least three days or requiring hospitalisation).

3. Asthma Diagnosis:

Improvement in FEV1 ≥ 12% or 200ml predicted after inhalation of 400mcg salbutamol OR Diurnal variation in PEF: amplitude % mean of twice daily PEF > 8% OR Decrease in FEV1 ≥ 12% and >200ml within 4 weeks after tapering treatment with one or more of the following drugs: ICS, OCS, LABA, SABA PLUS A history of wheeze occurring spontaneously or on exertion.

Exclusion Criteria:

1. Patients with a FEV1 < 1L

2. Any other active lung condition

3. Subjects unable to give consent