Nocturnal TLA for Severe Allergic Asthma After Withdrawal of Omalizumab Therapy
Condition: Severe Allergic Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is a randomized, controlled study with a 48-week treatment phase to determine the
      clinical efficacy of temperature controlled laminar flow device (TLA, Airsonett™) in the
      patients with severe allergic asthma who are withdrawal of omalizumab therapy
    

Detailed description: 
      This is a randomized, controlled study with a 48-week treatment phase to determine the
      clinical efficacy of temperature controlled laminar flow device (TLA, Airsonett™) in the
      patients with severe allergic asthma who are withdrawal of omalizumab therapy. All patients
      will be recruited from outpatient clinics of Thoracic Department of Chang Gung Memorial
      Hospital and meet the inclusion criteria. After entry the study, these patients will
      continuous their concomitant asthma medicines, except the treatment of omalizumab. These
      patients will be randomized (1:1) to receive TLA device or matching Control group. The
      participants will be recorded by randomized number to protect their private information. To
      minimize a potential treatment group imbalance of clinical asthma management practice and
      concomitant asthma medication use, randomization will be stratified by concomitant asthma
      medication [in addition to inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA)]
      use at baseline: (1) patients not receiving theophylline, oral β2-agonists, antileukotrienes
      or maintenance oral steroids; (2) patients receiving one or more from theophylline, oral
      β2-agonists and anti-leukotrienes, but not receiving maintenance oral steroids; (3) patients
      receiving maintenance oral steroids. The doses of ICS and LABA (taken separately or as a
      fixed combination) and other concomitant asthma medications will be kept constant through the
      treatment period. If they have asthma exacerbation of emergency visit or/and hospitalization,
      or > or =2 episodes of asthma exacerbation (defined as a worsening of asthma symptoms
      requiring treatment with systemic corticosteroids), the patients either with TLA or Control
      group will return to start the omalizumab therapy till the end of 48-week follow-up.
      Omalizumab dose is based on the patient's body weight and total serum immunoglobulin E (IgE)
      level at screening and is administered every 2 or 4 weeks to provide a dose of at least 0.016
      mg/kg per IU/ml of IgE. Patients are permitted short-acting β2-agonist rescue medication as
      required.

      Patients make study visits at weeks 0, 2, 4, 12, 24, 36 and 48 of the treatment phase. The
      primary efficacy variable is the first time to asthma exacerbations during the 48-week TLA
      treatment phase. Rate of hospitalization, and emergency visit per year will be also recorded.
      Diary cards are used to record the clinical symptom score, asthma control test (ACT) and use
      of rescue medication in the internet of Asthma Help.

      Quality of life will be assessed using the Sino-Nasal Outcome Test (SNOT-22) score at weeks
      0, 12, 24, 36 and 48 of the treatment phase. Spirometry and exhaled NO will be performed at
      each visit. All visits include assessment of vital signs and physical examination.
    

Intervention name(s): Nocturnal Temperature Controlled Laminar Flow Device; None Device
Intervention type(s): Device; Other
Intervention description(s): Record of the time to first asthma exacerbation, lung function and exhaled NO level; Record of the time to first asthma exacerbation, lung function and exhaled NO level
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomized, controlled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Controlled Laminar Airflow Device; Omalizumab