Inflammation and Corticosteroid Responsiveness in Severe Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00180661
First received: September 12, 2005
Last updated: May 19, 2008
Last verified: May 2008
  Purpose

Some patients with mild asthma may develop severe asthma. It is not known what makes patients with mild asthma become severe, and we plan to find out why this happens. Patients with severe asthma may have a different type of inflammation in the airway tubes. Patients with severe asthma do not get as much benefit from taking steroid inhalers or tablets compared to asthma patients with mild disease. The study hypothesis is that the inflammation in severe asthma is such that it makes steroids less effective in treating asthma. We will find out what possible abnormalities there are in the blood cells and the bronchoalveolar macrophage cells in the lungs of patients with severe asthma compared to those with mild or moderate asthma.


Condition Intervention Phase
Asthma
Drug: Prednisolone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inflammation and Corticosteroid Responsiveness in Severe Asthma

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Lung function FEV1 [ Time Frame: days ] [ Designated as safety issue: Yes ]
  • Suppression of monocyte activation and alveolar macrophage activation by dexamethasone ex-vivo [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Effect of corticosteroids on release of cytokines from macrophages [ Time Frame: Once ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exhaled NO [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Biopsy eosinophils [ Time Frame: Once ] [ Designated as safety issue: No ]
  • Sputum eosinophils [ Time Frame: Once ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2003
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Treatment with prednisolone
Drug: Prednisolone
40 mg per day for 2 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The final diagnosis of severe asthma will be made according to the screening steps we have set up. The definition will require the presence of one or both major criteria (treatment with continuous or near continuous oral corticosteroids and/or requirement for treatment with high dose inhaled steroids) and two minor criteria.

Patients who do not fit the criteria of severe asthma will not be entered into the study.

Age 18-60; both sexes.

For the investigation of fiberoptic bronchoscopy, other additional inclusion criteria will be imposed:

  1. Post-bronchodilator FEV1 greater than 40% on the day of the bronchoscopy
  2. No evidence of an exacerbation of asthma within the past 4 weeks.
  3. Ability to cooperate with procedures
  4. Ability to give consent
  5. Current smokers, and ex-smokers with greater than 10 pack years history of smoking.

Exclusion criteria

Pregnancy or unreliable contraceptive measures in child-bearing woman. he bronchoscopist has determined the subject is clinically appropriate for bronchoscopy

-

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180661

Contacts
Contact: Fan Chung, MD 44 2073528121

Locations
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6HP
Contact: Sally Meah    44 207 351 8051      
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Kian Fan Chung, MD Imperial College London
  More Information

Publications:
Responsible Party: Kian Fan Chung, Imperial College
ClinicalTrials.gov Identifier: NCT00180661     History of Changes
Other Study ID Numbers: HL-69155
Study First Received: September 12, 2005
Last Updated: May 19, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Severe asthma
corticosteroid responsiveness

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014