N/A N=18

Airway Smooth Muscle and Asthma Severity

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00779870 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Difference in ASM Mass Between Groups

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: bronchoscopy (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in ASM Mass Between Groups	—	—
PRIMARY Difference in ASM Proliferation, Migration and Cytokine Release Between Groups	—	—
PRIMARY Difference in Intracellular Oxidative Stress Mechanisms From ASM Between Groups	2; 3; 3	0.06
SECONDARY Correlation Between ASM Mass and Airway Hyper-responsiveness (PC20)	—	—

Summary

Our hypothesis is that the severity of asthma is determined by the way in which airway smooth muscle cells grow and release inflammatory mediators. Our main objective is to establish how the properties of the airway smooth muscle cell varies with asthma severity. Environmental agents, such as cigarette smoke, and inflammation can give rise to oxidative stress - this is a process whereby harmful chemicals called free radicals are formed in the body and damage tissues. The damage caused can be limited/prevented by protective, or anti-oxidant mediators. We will also look at molecules involved in oxidative stress which may affect the way in which the airway smooth muscle grows and produces inflammatory mediators.

Eligibility Criteria

Inclusion criteria - Asthma Age 18-60 Physician diagnosis of asthma Intermittent/mild, moderate and severe asthma as per GINA guidelines [1]

For the severe asthma subjects, they will also have the following:

Major characteristics (at least one of the following criteria)

Treatment with continuous or near continuous (>50% of year) oral corticosteroids
Requirement for treatment with high dose inhaled corticosteroids (ICS) Minor characteristics (at least 2 out of the following)
Requirement for daily treatment with a controller medication in addition to ICS e.g. LABA, theophylline, leukotriene antagonist
Asthma symptoms requiring SABA on a daily or near daily basis
Persistent airways obstruction (FEV1 20%)
One or more emergency care visits for asthma per year
3 or more steroid "bursts" per year
Prompt deterioration with ≤ 25% reduction in oral or ICS
Near fatal asthma event in the past

Reference [1] GINA - The Global Initiative for Asthma. www.ginasthma.com

Exclusion criteria - Asthma Intubation for asthma within 6 months of entry into this study Current smokers, or less than 3 years since quitting smoking (< 5 pack/years) Less than 4 weeks from an exacerbation On steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin Concomitant anti-IgE therapy On anti-platelet or anti-coagulant drugs Low platelet count Pregnancy or breast-feeding Previous bronchoscopy within three months of this study

Healthy volunteer subjects:

We are aiming for 5 atopic and 5 non-atopic healthy volunteers.

Inclusion criteria

Age 18 - 60 Non smokers (or less than 5 pack/yrs if ex-smokers) Normal lung function

Exclusion criteria

History of asthma or allergic rhinitis Any chronic illness Current smokers, or less than 3 years since quitting smoking (< 5 pack/years) PC20 less than 16mg/ml On anti-platelet or anti-coagulant drugs Low platelet count Pregnancy or breast-feeding Previous bronchoscopy within three months of this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00779870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.