Table 1 Inclusion and exclusion criteria in Polish drug programme with OMB
Inclusion Criteria | |
|---|---|
1 | Adult and adolescent patients with severe, uncontrolled allergic asthma (per GINA guidelines), allergy to perennial allergens confirmed with positive results of skin prick or specific IgE tests |
2 | The need to use high doses of ICS (> 1000 mcg of beclomethasone dipropionate (CFC) per day or equivalent) in combination with a second controller (i.e. LABA, LTRA, theophylline) |
3 | Frequent use of OCS in the past, including the last 6 months |
4 | Total serum IgE levels 30–1500 IU / ml |
5 | Unequivocal in vitro reactivity to a perennial allergen in patients with total serum IgE (tIgE) levels below 76 IU/ml |
6 | The fulfilment of at least three of the following criteria: a) Uncontrolled asthma symptoms (lack of asthma control in ACQ > 1.5 points) b) Three or more episodes of exacerbations a year requiring systemic corticosteroids or increase their current dose. c) Hospitalization in the past 12 months due to asthma exacerbation d) Near fatal asthma episode in the past e) Persistent airflow limitation (forced expiratory flow in one second (FEV1) < 60% predicted of normal or daily variability of peak expiratory flow (PEF) > 30%) |
7 | Weight 20–150 kg |
8 | Non-smoker |
9 | The exclusion of other than allergic reactions to inhaled perennial allergens reasons causing severe asthma |
10 | Exclusion criteria |
11 | Exacerbations during treatment with OMB if the number is equal to or greater than in the period prior to the treatment year |
Criteria of efficacy not met: a) Response to therapy in GETE less than excellent (complete control of asthma)/good (marked improvement) b) Meeting 2 of the following 3 criteria: • Insufficient improvement in asthma control based on ACQ (change in ACQ score less than or equal to 0.5 points) • Insufficient improvement of the quality of life based on AQLQ or mini AQLQ (change in AQLQ score less than or equal to 0.5 points) • OCS dose reduction of less than or equal 5 mg (only patients treated with OCS before enrolment) | |
12 | Current smoker |
13 | Noncompliance or poor adherence |
14 | Initiation of therapy with immunosuppressive drugs, anticancer, infusions of immunoglobulins or other biological agents |
15 | The occurrence of any contraindications to the use of OMB |
16 | Pregnant or breastfeeding woman |