SoMOSA: Study of mechanisms of action of omalizumab in severe asthma

Completed

• Conditions: Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory; Respiratory; Asthma

• Registration Number: ISRCTN15124178
• Lead Sponsor: Southampton University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-06
• Last Update Posted: 19 February 2018
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Aged 18-70 years
2. Severe uncontrolled asthma (GINA step 4 and 5) despite daily treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). (High-dose ICS will be a minimum twice daily dose of 800 mcg of beclomethasone dipropionate equivalent inhaler for at least 8 weeks before screening). Potential participants will need to fulfil the criteria for uncontrolled asthma as judged by their Asthma Control Questionnaire (ACQ) score =1.5 during the screening period.
3. Participants on maintenance treatment with oral corticosteroids will also be included and will also have to meet the same ACQ inclusion criterion (ACQ=1.5)
4. Atopic, as identified by positive skin prick test or in vitro reactivity to a perennial aeroallergen
5. Two or more documented severe asthma exacerbations within the previous 12 months that require courses of prednisolone, defined as increased asthma symptoms requiring treatment in the community or in hospital with systemic corticosteroid rescue therapy or an increase in daily oral corticosteroids for participants already on maintenance oral corticosteroids for >2 months
6. Frequent daytime symptoms or night-time awakenings
7. Reduced lung function (FEV1 <80%) recorded anytime within the past 2 years
8. IgE level of 30 to 1500 IU/mL
9. Body weight less than 150 kg
10. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form
11. Able to read, comprehend, and write at a sufficient level to complete study related materials

Exclusion Criteria

1.An exacerbation requiring treatment with systemic corticosteroids (or an increase in the baseline dose of OCS) within the 30 days before screening
2. Active lung disease other than asthma
3. Treatment with Xolair or another biologic in the 12 months before screening
4. Elevated serum IgE levels for reasons other than allergy (for example, parasite infections, the hyperimmunoglobulin E syndrome, the Wiskott–Aldrich syndrome, or bronchopulmonary aspergillosis)
5. The following medication is not allowed during the run-in and treatment period and should not have been taken for at least 3 months prior to screening: methotrexate, cyclosporine, intravenous immunoglobulin or immunosuppressant’s
6. Current smokeror having smoked in the past year. Ex-smokers will have to be confirmed by a negative cotinine test. If there is a history of smoking for >10 pack years, then asthma diagnosis should have been made before the age of 40 and objective evidence of reversibility of FEV1>12% and 200ml should be available [either previously recorded or done as part of screening for this study]. Potential participants where an asthma/COPD overlap is suspected should not be included.
7. The participant has a history of current recreational drug use or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation
8. Female patient who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding
9. Those participants who, in the opinion of the investigator, have a risk of non-compliance with study procedures
10. The participant has a recent history of incapacitating psychiatric disorders
11. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 4 weeks of baseline assessments (in such participant assessments should be deferred until after 4 weeks have lapsed from the cold)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of (PGD2) 2,3-dinor-11-ß-PGF2a in urine is measured at baseline and 16 weeks.

Secondary Outcome Measures

Name	Time	Method
Clinical response to Xolair assessed by GETE at 16 weeks.