ICS+LABA Vs. ICS+LABA+Omalizumab: Impact on Asthma Control and Gene Expression

Plain-language summary

This study compared inhaled corticosteroid plus LABA therapy with the same treatment plus Omalizumab, looking at asthma control and gene expression. Adults aged 18 and older with asthma confirmed by a provocation test took part; Omalizumab was added for patients whose asthma was poorly controlled and who had high IgE levels. Conducted by Taipei Tzu Chi Hospital, this Phase 4 study has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Intervention

Foster BDP/Formoterol, Omalizimab

Start date

1/1/2023

Estimated completion

3/31/2024

Countries

Taiwan

Related genes

Locations

• New Taipei City, Taiwan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 18 years old with a confirmed asthma diagnosis via a provocation test
* The treatment of asthma was according to GINA guideline. ICS with LABA group are patients of asthma presented as stage III. The adding of omalizuamb is patients with poor control of ICS with LABA with high IgE.

Exclusion Criteria:

* age less than 18 years old
* current smokers
* individuals with other lung diseases (such as lung cancer, chronic obstructive pulmonary disease, bronchiectasis, or interstitial lung disease)
* those with systemic conditions like diabetes, hypertension, myocardial infarction, or congestive heart failure.
* Individuals who opted not to participate were also excluded.