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.
John Hunter Hospital
50 participants
Oct 1, 2014
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
Inclusion Criteria27
- Participants:
- This is a prospective case control study; we will recruit the following subjects:
- Stable allergic asthma. Subjects aged 6 – 75 years with mild-to-moderate asthma (control of asthma symptoms (Asthma control questionnaire (ACQ6) score <1.5), and who have evidence of AHR to hypertonic saline and allergic sensitization to common inhalant allergens. On less than 1000mcg/d beclomethasone equivalent.
- Severe uncontrolled allergic asthma, suitable for Omalizumab. Participants with severe refractory asthma, 18 years and older who have persistent poor asthma control (ACQ6 >1.5) despite treatment with greater than 1000mcg/d beclomethasone equivalent per day and a history of an acute exacerbation in the last 12 months requiring systemic corticosteroids for 3 days or more, and who are suitable for commencement of treatment with omalizumab.
- Healthy controls. Non-asthmatic subjects aged 6 – 75 years with normal lung function and no allergic sensitization.
- Cases with severe allergic asthma
- Asthma diagnosis, and who have evidence of AHR to hypertonic saline or change in FEV1 following bronchodilator >12% and at least 200mls.
- Age: 18 years and older and determined to be suitable for omalizumab treatment
- Regular maintenance treatment with inhaled corticosteroid and long acting beta agonist (dose of ICS >1000mcg/d fluticasone or 1600mcg/d of budesonide)
- Evidence of atopy, defined by positive skin prick test or RAST.
- Total serum IgE >75 IU/ml
- Persistent poor symptom control (ACQ6 >1.5).
- Oral corticosteroid use of at least 10mg/d of prednisone for at least 6 weeks in the last 12 months.
- Current non-smoker with <10 pack year history of smoking
- Cases with controlled mild to moderate allergic asthma
- Asthma diagnosis, and who have evidence of AHR to hypertonic saline or change in FEV1 following bronchodilator >12% and at least 200mls.
- Age 6 -75 years
- Regular maintenance treatment with inhaled corticosteroid (dose of ICS <1000mcg/d fluticasone or 1600mcg/d of budesonide)
- Evidence of atopy, defined by positive skin prick test or RAST.
- Good asthma symptom control (ACQ6 <1.5)
- Current non-smoker with <10 pack year history of smoking
- Healthy controls
- Normal lung function; FEV1 >80% predicted, FER >70% predicted and no evidence of AHR to hypertonic saline or change in FEV1 following bronchodilator >12% and at least 200mls.
- Age 6 -75 years
- No previous history of chronic cardiac or respiratory disease
- Non-atopic, negative skin prick test or RAST
- Current non-smoker with <10 pack year history of smoking
Exclusion Criteria4
- Acute exacerbation of asthma within the last 4 weeks that required a change in treatment
- History of a viral respiratory tract infection within the last 4 weeks.
- Current smoker or former smoker with >10 pack year history of smoking.
- Inability to understand or comply with the study requirements
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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 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)
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ACTRN12614001109695