A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics

NCT02270827 | Terminated

• 1 other identifier: 2013AT001B
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on severe asthmatics and their asthma symptoms. 40% of asthma patients continue to experience symptoms and up to 5% of these have difficult-to-control asthma despite continually improving treatments. Severe asthmatics experience clinically-significant worse health-related quality of life than those than those with less severe asthma. Poorer health-related quality of life can be as a consequence of frequent, severe symptoms, which prevent the patient from continuing a normal, active lifestyle. The Royal Brompton Hospital uses the treatment regimen of intravenous (IV) Aminophylline and IV Hydrocortisone which appears to improve symptoms and reduce exacerbations. At present there is anecdotal evidence to support these assumptions. The objective of this study is to determine whether there is any objective evidence of improvement, in particular looking at lung function, symptoms and cardiovascular function.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• To measure a significant improvement in lung function in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone

  Lung function will be measured via spirometry (large airways) and impulse oscillometry (small airways) before and after treatment

  Day 0 and Day 7 (+/- 3 days)

Secondary Outcomes (4)

• To measure a significant improvement in symptoms in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone

  Day 0 and Day 7 (+/- 3 days)

• To measure a significant improvement in quality of life in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone

  Day 0 and Day 7 (+/- 3 days)

• To measure a significant improvement in exercise tolerance in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone

  Day 0 and Day 7 (+/- 3 days)

• To measure a significant cardiovascular change in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone

  Day 0 and Day 7 (+/- 3 days)

Interventions

Aminophylline DRUG

intravenous medication

Hydrocortisone DRUG

Intravenous medication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe Asthmatic Adults

You may qualify if:

• Age 18-65 years
• Diagnosis of severe asthma
• Confirmed therapy adherence via serum Prednisolone and cortisol levels

You may not qualify if:

• Mild and moderate asthma
• Community acquired pneumonia
• Acute porphyria
• Pregnant and breast feeding women
• Patients hypersensitive to ethylenediamine or allergic to the theophyllines, caffeine and/or theorbromine.
• Patient with known hypersensitivity to components and in systemic fungal infection
• Patients that are being administered live attenuated vaccines.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, sw3 6hp, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

Aminophylline; Hydrocortisone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Andrew Menzies-Gow

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 21, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

GB (1)