RecruitingACTRN12614001109695

A study to investigate the underlying molecular characteristics of allergic asthma

A study to investigate the underlying molecular characteristics of allergic asthma by comparing biomarkers in the airways or blood among healthy subjects, mild and severe asthmatics.


Sponsor

John Hunter Hospital

Enrollment

50 participants

Start Date

Oct 1, 2014

Study Type

Interventional

Conditions

Summary

The purpose of this study is to determine if markers in the airways or blood can predict when someone with mild/moderate or severe asthma is at risk of developing an acute asthma attack associated with a virus infection. This may allow us to better determine who needs treatment to prevent attacks of asthma and for how long.


Eligibility

Sex: Both males and femalesMin Age: 6 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at markers in the airways and blood that might predict when someone with allergic asthma is about to have a bad asthma attack triggered by a virus. Researchers hope to find signals that can identify which asthma patients are most at risk, so that their treatment can be adjusted before the attack happens. The study includes people with mild to moderate asthma, severe asthma, and healthy volunteers without asthma. You may be eligible if: - You are between 6 and 75 years old - You have been diagnosed with allergic asthma (mild-moderate or severe) - You have had a positive allergy test (skin prick or blood test) - You are a non-smoker (or smoked fewer than 10 packs per year lifetime) - OR you are a healthy non-asthmatic volunteer without allergies (as a control) You may NOT be eligible if: - You have had an asthma attack or changed your treatment in the last 4 weeks - You have had a respiratory infection in the last 4 weeks - You are a heavy smoker (more than 10 pack years) - You are unable to understand or follow the study instructions Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Group 1: Subjects with mild to moderate allergic asthma (n=20)who are controlled on inhaled corticosteroids will be asked to withdraw their inhaled corticosteroids (ICS) immediately following a 2 week

Group 1: Subjects with mild to moderate allergic asthma (n=20)who are controlled on inhaled corticosteroids will be asked to withdraw their inhaled corticosteroids (ICS) immediately following a 2 week run-in prior to an 8 week observational period. Subjects will visit the clinic every two weeks where their asthma status will be assessed. Group 2: Subjects who have attended the severe asthma clinic at the John Hunter Hospital and are deemed suitable under current PBS guidelines for add on therapy for difficult asthma with omalizumab (Xolair) will be recruited to an observational study during their 6 month Xolair trial. Xolair administration will follow standard therapeutic guidelines and be administered every 2 or 4 weeksby the Xolair clinic nurse. The dose of omalizumab for each patient is detrmined by IgE levels and body weight. Frequency of dosing is determined by clinical status as assessed by the supervising physician. For the purposes of this study this group of subjects will be seen once per month only. If omalizumab is administered fortnightly, subjects enrolled in this study will be seen every second omalizumab injection. Group 3: Healthy control volunteers will be recruited (n=20) to provide induced sputum and bloods samples for comparison to groups 1 & 2. The length of study involvement for this group will be dependent on the availablility of the subject to attend a post-baseline clinic visit if the subject catches a cold. These subjects will remain on stand-by and will be considered active participants until either the subject expresses an unwillingness to be involved in the study or the investigators obtain sufficient data to complete the study.


Locations(1)

John Hunter Hospital Royal Newcastle Centre - New Lambton

NSW, Australia

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ACTRN12614001109695