How do thick airway walls affect airway hyperresponsiveness in asthma.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12610000561088
• Date of registration: 12/07/2010
• Prospective Registration: No
• Primary sponsor: The Woolcock Institute of Medical Research
• Public title: How do thick airway walls affect airway hyperresponsiveness in asthma.
• Scientific title: Effect in asthmatic subjects of changes in airway wall thickness induced by inhaled corticosteroids on airway hyperresponsiveness
• Date of first enrolment: 01/08/2008
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12610000561088.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Dr Nathan Brown

• Name: Dr Nathan Brown

Key inclusion & exclusion criteria

Inclusion criteria: doctor-diagnosed asthma; current symptoms of asthma; airway hyperresponsiveness to methacholine; taking no more than 800ug Beclomethasone diproprionate (BDP) equivalent/day;
Exclusion criteria: current smokers within the last year or having more than 10 years pack history; pregnancy; history of lung cancer, lung reduction surgery, major illness (heart attack, stroke, epilepsy, rheumatoid arthritis); respiratory infection or oral pregnisolone use within the four weeks prior to study participation

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Asthma;
Asthma

Respiratory - Asthma

Intervention(s)

All subjects will be treated with fluticasone as inhaled combination therapy (Seretide) at 500ug twice daily (bd) for twelve weeks

Primary Outcome(s)

Change in airway wall thickness, measured using high resoution computed tomography (HRCT) scans, during 3 months treatment correlates with a change in airway responsiveness, measured using methacholine bronchial challenge tests.[after 3 months of treatment]

correlation between airway stiffness, measured using the forced oscillation technique, and airway responsiveness, measured using methacholine bronchial challenge tests[before and after 3 months of treatment]

Secondary Outcome(s)

correlation between airway wall thickening, measured using high resoution computed tomography (HRCT) scans, and airway stiffness, measured using the forced oscillation technique.[before and after 3 months of treatment]

Secondary ID(s)

National Health and Medical Research Council (NHMRC) Grant No: X08-0072

Source(s) of Monetary Support

NHMRC

Ethics review

Status: Approved
Approval date:
Contact:

Sydney South West Area Health Service