Asthma PatientsPhase 4NCT06869382
ICS+LABA Vs. ICS+LABA+Omalizumab: Impact on Asthma Control and Gene Expression
A Phase 4 study testing Foster BDP/Formoterol and Omalizimab in people with Asthma Patients, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Asthma is a chronic respiratory disease characterized by airway inflammation and obstruction, leading to wheezing, breathlessness, chest tightness, and coughing. Uncontrolled asthma impairs daily activities and reduces quality of life, making it a significant global health concern affecting 334 million people… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma Patients
- What is being tested?
- Foster BDP/Formoterol and Omalizimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of ICS Combined with LABA Versus Addition of Omalizumab on Transcriptomic Expression Profiles in Patients with Allergic Asthma
Asthma is a chronic respiratory disease characterized by airway inflammation and obstruction, leading to wheezing, breathlessness, chest tightness, and coughing. Uncontrolled asthma impairs daily activities and reduces quality of life, making it a significant global health concern affecting 334 million people worldwide. Proper management is essential to minimize its impact.
The Global Initiative for Asthma (GINA) recommends inhaled corticosteroids (ICS) combined with long-acting beta-agonists (LABA) as a cornerstone therapy for moderate to severe asthma, reducing inflammation and providing sustained bronchodilation. This combination improves symptom control and prevents exacerbations more effectively than ICS alone.
Read more
For severe asthma inadequately controlled with ICS+LABA, biologics such as omalizumab (Xolair®) may be added. Omalizumab, a monoclonal antibody targeting immunoglobulin E (IgE), inhibits allergic inflammation by preventing IgE binding to mast cells and basophils. Clinical studies show it reduces asthma attacks, improves lung function, and decreases corticosteroid dependence.
While ICS+LABA is the primary treatment, omalizumab is often introduced when control remains insufficient. However, transcriptomic differences between these treatments remain unclear. Investigating mRNA expression changes may provide insights for optimizing asthma management.
Research purposes:
This study aims to compare transcriptomic expression profiles in patients with allergic asthma treated with ICS+LABA versus those receiving ICS+LABA with the addition of omalizumab. By analyzing RNA expression differences, the investigators seek to identify key molecular pathways influenced by these treatments, investigate omalizumab's impact on airway inflammation and immune regulation, and explore potential biomarkers for predicting treatment response. Understanding these transcriptomic changes may provide insights into optimizing therapeutic strategies and improving personalized asthma management.
The main inclusion and exclusion conditions of the study:
Participants were adults over 18 years old with a confirmed asthma diagnosis via a provocation test, receiving treatment according to GINA guidelines. The ICS+LABA group included asthma patients classified as stage III, while the ICS+LABA+omalizumab group consisted of patients with poor asthma control despite ICS+LABA therapy and elevated IgE levels. Exclusion criteria included current smokers, individuals with other lung diseases (e.g., lung cancer, COPD, bronchiectasis, ILD), or systemic conditions such as diabetes, hypertension, myocardial infarction, or heart failure. Those who declined participation were also excluded. Healthy controls had no history of asthma, systemic diseases, or medication use.
Research Methods and Procedures:
Pulmonary Function Tests PFTs followed American Thoracic Society guidelines using a Medical Graphics Corporation spirometer. Measured parameters included forced vital capacity (FVC), forced expiratory volume in one second (FEV1), mid-maximum expiratory flow (MMEF), and peak expiratory flow rate (PEFR).
Blood Tests Comprehensive blood tests included RNA transcriptome analysis, allergen panel, IgE levels, complete blood count with differentials, hemoglobin, liver and kidney function tests, C-reactive protein (CRP), electrolytes, and chest X-rays.
Asthma Control Assessment The Chinese-language Asthma Control Test (ACT) was used to evaluate asthma control, with scores ranging from 0 to 25, where higher scores indicate better management.
Library Preparation and Sequencing RNA libraries were prepared using the TruSeq Stranded mRNA Library Prep Kit (Illumina), followed by mRNA extraction, fragmentation, cDNA synthesis, adapter ligation, and purification. Library quality was assessed using the Agilent Bioanalyzer 2100 system and real-time PCR. Sequencing was performed on the Illumina NovaSeq 6000 platform, generating 150 bp paired-end reads.
Bioinformatics Analysis Raw sequence data were processed using Fastp for quality control, aligned to reference genomes using STAR, and quantified with RSEM. Differential gene expression was analyzed with edgeR, while Gene Ontology (GO) and KEGG pathway enrichment were performed using clusterProfiler and ShinyGO. RNA sequencing data are available at the National Center for Biotechnology Information (NCBI).
- Conditions
- Asthma Patients
- Being tested
- Foster BDP/Formoterol, Omalizimab
- Keywords
- asthma, airway inflammation, omalizumab, RNA transcriptome
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foster BDP/FormoterolDrug
Foster is a combination therapy containing beclometasone dipropionate (an inhaled corticosteroid, or ICS) and formoterol fumarate (a long-acting beta-agonist, or LABA), which is used for managing asthma and chronic obstructive pulmonary disease (COPD).
OmalizimabDrug
Omalizumab is a monoclonal antibody that specifically targets immunoglobulin E (IgE), a key mediator in allergic asthma. By binding to free IgE in the bloodstream, omalizumab prevents it from attaching to FcεRI receptors on mast cells and basophils, inhibiting the allergic inflammatory cascade that contributes to asthma exacerbations and bronchoconstriction. This intervention is particularly useful in patients with severe allergic asthma, who have high levels of IgE and have not responded well to conventional therapies such as inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA).
| Study group | Role | What they receive |
|---|---|---|
| ICS+LABA therapy | Experimental | ICS+LABA therapy refers to the combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) in the treatment of asthma Receives: Drug: Foster BDP/Formoterol |
| ICS+LABA+Omalizumab | Experimental | ICS+LABA+Omalizumab therapy is a combination treatment used for patients with moderate to severe asthma that is not well-controlled with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) alone Receives: Drug: Foster BDP/Formoterol; Drug: Omalizimab |
| control group | No intervention | healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression Profiles and Differentially Expressed Genes (DEGs) Identified by RNA Sequencing
Purified RNA was used to generate sequencing libraries with the TruSeq Stranded mRNA Library Prep Kit (Illumina, San Diego, CA, USA). mRNA was extracted from 1 µg of total RNA using oligo(dT)-coupled magnetic beads, followed by heat fragmentation into smaller fragments. First-strand cDNA synthesis was performed using reverse transcriptase and random primers, followed by second-strand synthesis. After adenylation at the 3' ends, adapter ligation, and purification with the AMPure XP system (Beckman Coulter, Beverly, USA), library quality was assessed using the Agilent Bioanalyzer 2100 system and real-time PCR.
Qualified libraries were sequenced on the Illumina NovaSeq 6000 platform, generating 150 bp paired-end reads. Raw sequencing data were processed using the Fastp program (version 0.23.4) to remove adapter sequences and low-quality bases. Gene expression levels were quantified and normalized as transcripts per million (TPM). Differential gene expression analysis was performed by co
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (8)
Pulmonary function test
Patients underwent pulmonary function tests following the guidelines of the American Thoracic Society, using a spirometer manufactured by Medical Graphics Corporation in the USA. Measurements included forced vital capacity (FVC, L) and forced expiratory volume in the first second (FEV1, L). One patient had lower lung function.
Measured: From enrollment to the end of treatment at 12 weeks
Serum IgE Concentration
Total serum IgE levels were measured using an immunoassay. The concentration of IgE (IU/mL) was assessed at baseline and at the end of treatment to evaluate changes over time.
This outcome measure tracks the number of participants with elevated total IgE levels during the study period. The cutoff value for total IgE was set at 200 IU/mL, and 16 participants had total IgE levels above this threshold.
Measured: From enrollment to the end of treatment at 12 weeks
Asthma control test
The Chinese-language Asthma Control Test (ACT) was used to assess asthma control level.6 The ACT contains five questions, each rated on a scale from 0 to 5, giving a possible total score between 0 and 25, where higher scores indicate improved asthma management.
Number of Participants with Poor Asthma Control (ACT Score < 20) This outcome measure tracks the number of participants with poor asthma control, as determined by the Asthma Control Test (ACT). The normal ACT score is 20 or higher, with scores below 20 indicating poor control. Eight participants had ACT scores lower than 20, indicating poor asthma control.
Measured: From enrollment to the end of treatment at 12 weeks
Body Mass Index (BMI)
Body Mass Index (BMI) was calculated as weight in kilograms divided by height in meters squared (kg/m²). This measurement was used to assess the participants' overall body composition and its potential impact on asthma severity and treatment response.
Measured: From enrollment to the end of treatment at 12 weeks
Complete Blood Count (CBC)
Complete Blood Count (CBC) with differentials included measurements of white blood cell (WBC) count in 10⁹/L, red blood cell (RBC) count in 10¹²/L, and platelet count in 10⁹/L. These parameters were assessed to evaluate hematologic status and monitor potential changes during the study period. Number of Participants with Normal Laboratory Test Results All participants had normal complete blood count (CBC) results.
Measured: From enrollment to the end of treatment at 12 weeks
Hemoglobin (Hb) levels
Hemoglobin (Hb) levels were measured in grams per deciliter (g/dL) to assess potential anemia or other hematologic abnormalities in study participants. All participants had normal Hemoglobin (Hb) levels .
Measured: From enrollment to the end of treatment at 12 weeks
Liver Function Markers
Liver function was assessed by measuring aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in units per liter (U/L). All participants had Liver Function.
Measured: From enrollment to the end of treatment at 12 weeks
Kidney function
Kidney function was evaluated using serum creatinine (Cr) and blood urea nitrogen (BUN), both measured in milligrams per deciliter (mg/dL). These parameters were assessed to monitor renal function, detect potential impairment.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869382
- Sponsor's protocol ID
- IRB number 10-XD-154
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of ICS Combined with LABA Versus Addition of Omalizumab on Transcriptomic Expression Profiles in Patients with Allergic Asthma
- ClinicalTrials.gov ID
- NCT06869382
- Acronym / sponsor ID
- IRB number 10-XD-154
- Conditions
- Asthma Patients
- Keywords
- asthma, airway inflammation, omalizumab, RNA transcriptome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma is a chronic respiratory disease characterized by airway inflammation and obstruction, leading to wheezing, breathlessness, chest tightness, and coughing. Uncontrolled asthma impairs daily activities and reduces quality of life, making it a significant global health concern affecting 334 million people worldwide. Proper management is essential to minimize its impact.
The Global Initiative for Asthma (GINA) recommends inhaled corticosteroids (ICS) combined with long-acting beta-agonists (LABA) as a cornerstone therapy for moderate to severe asthma, reducing inflammation and providing sustained bronchodilation. This combination improves symptom control and prevents exacerbations more effectively than ICS alone.
For severe asthma inadequately controlled with ICS+LABA, biologics such as omalizumab (Xolair®) may be added. Omalizumab, a monoclonal antibody targeting immunoglobulin E (IgE), inhibits allergic inflammation by preventing IgE binding to mast cells and basophils. Clinical studies show it reduces asthma attacks, improves lung function, and decreases corticosteroid dependence.
While ICS+LABA is the primary treatment, omalizumab is often introduced when control remains insufficient. However, transcriptomic differences between these treatments remain unclear. Investigating mRNA expression changes may provide insights for optimizing asthma management.
Research purposes:
This study aims to compare transcriptomic expression profiles in patients with allergic asthma treated with ICS+LABA versus those receiving ICS+LABA with the addition of omalizumab. By analyzing RNA expression differences, the investigators seek to identify key molecular pathways influenced by these treatments, investigate omalizumab's impact on airway inflammation and immune regulation, and explore potential biomarkers for predicting treatment response. Understanding these transcriptomic changes may provide insights into optimizing therapeutic strategies and improving personalized asthma management.
The main inclusion and exclusion conditions of the study:
Participants were adults over 18 years old with a confirmed asthma diagnosis via a provocation test, receiving treatment according to GINA guidelines. The ICS+LABA group included asthma patients classified as stage III, while the ICS+LABA+omalizumab group consisted of patients with poor asthma control despite ICS+LABA therapy and elevated IgE levels. Exclusion criteria included current smokers, individuals with other lung diseases (e.g., lung cancer, COPD, bronchiectasis, ILD), or systemic conditions such as diabetes, hypertension, myocardial infarction, or heart failure. Those who declined participation were also excluded. Healthy controls had no history of asthma, systemic diseases, or medication use.
Research Methods and Procedures:
Pulmonary Function Tests PFTs followed American Thoracic Society guidelines using a Medical Graphics Corporation spirometer. Measured parameters included forced vital capacity (FVC), forced expiratory volume in one second (FEV1), mid-maximum expiratory flow (MMEF), and peak expiratory flow rate (PEFR).
Blood Tests Comprehensive blood tests included RNA transcriptome analysis, allergen panel, IgE levels, complete blood count with differentials, hemoglobin, liver and kidney function tests, C-reactive protein (CRP), electrolytes, and chest X-rays.
Asthma Control Assessment The Chinese-language Asthma Control Test (ACT) was used to evaluate asthma control, with scores ranging from 0 to 25, where higher scores indicate better management.
Library Preparation and Sequencing RNA libraries were prepared using the TruSeq Stranded mRNA Library Prep Kit (Illumina), followed by mRNA extraction, fragmentation, cDNA synthesis, adapter ligation, and purification. Library quality was assessed using the Agilent Bioanalyzer 2100 system and real-time PCR. Sequencing was performed on the Illumina NovaSeq 6000 platform, generating 150 bp paired-end reads.
Bioinformatics Analysis Raw sequence data were processed using Fastp for quality control, aligned to reference genomes using STAR, and quantified with RSEM. Differential gene expression was analyzed with edgeR, while Gene Ontology (GO) and KEGG pathway enrichment were performed using clusterProfiler and ShinyGO. RNA sequencing data are available at the National Center for Biotechnology Information (NCBI).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICS+LABA therapy | Experimental | Drug: Foster BDP/FormoterolICS+LABA therapy refers to the combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) in the treatment of asthma |
| ICS+LABA+Omalizumab | Experimental | Drug: Foster BDP/Formoterol, Drug: OmalizimabICS+LABA+Omalizumab therapy is a combination treatment used for patients with moderate to severe asthma that is not well-controlled with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) alone |
| control group | No intervention | –healthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foster BDP/FormoterolFoster is a combination therapy containing beclometasone dipropionate (an inhaled corticosteroid, or ICS) and formoterol fumarate (a long-acting beta-agonist, or LABA), which is used for managing asthma and chronic obstructive pulmonary disease (COPD). | Drug | ICS+LABA therapy, ICS+LABA+Omalizumab |
| OmalizimabOmalizumab is a monoclonal antibody that specifically targets immunoglobulin E (IgE), a key mediator in allergic asthma. By binding to free IgE in the bloodstream, omalizumab prevents it from attaching to FcεRI receptors on mast cells and basophils, inhibiting the allergic inflammatory cascade that contributes to asthma exacerbations and bronchoconstriction. This intervention is particularly useful in patients with severe allergic asthma, who have high levels of IgE and have not responded well to conventional therapies such as inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). | Drug | ICS+LABA+Omalizumab |
Primary outcome
Gene Expression Profiles and Differentially Expressed Genes (DEGs) Identified by RNA Sequencing
Time frame: From enrollment to the end of treatment at 12 weeks
Purified RNA was used to generate sequencing libraries with the TruSeq Stranded mRNA Library Prep Kit (Illumina, San Diego, CA, USA). mRNA was extracted from 1 µg of total RNA using oligo(dT)-coupled magnetic beads, followed by heat fragmentation into smaller fragments. First-strand cDNA synthesis was performed using reverse transcriptase and random primers, followed by second-strand synthesis. After adenylation at the 3' ends, adapter ligation, and purification with the AMPure XP system (Beckman Coulter, Beverly, USA), library quality was assessed using the Agilent Bioanalyzer 2100 system and real-time PCR. Qualified libraries were sequenced on the Illumina NovaSeq 6000 platform, generating 150 bp paired-end reads. Raw sequencing data were processed using the Fastp program (version 0.23.4) to remove adapter sequences and low-quality bases. Gene expression levels were quantified and normalized as transcripts per million (TPM). Differential gene expression analysis was performed by co
8 secondary outcomes
Pulmonary function test
Time frame: From enrollment to the end of treatment at 12 weeks
Serum IgE Concentration
Time frame: From enrollment to the end of treatment at 12 weeks
Asthma control test
Time frame: From enrollment to the end of treatment at 12 weeks
Body Mass Index (BMI)
Time frame: From enrollment to the end of treatment at 12 weeks
Complete Blood Count (CBC)
Time frame: From enrollment to the end of treatment at 12 weeks
Hemoglobin (Hb) levels
Time frame: From enrollment to the end of treatment at 12 weeks
Liver Function Markers
Time frame: From enrollment to the end of treatment at 12 weeks
Kidney function
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Foster BDP/Formoterol and Omalizimab in people with Asthma Patients, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression Profiles and Differentially Expressed Genes (DEGs) Identified by RNA Sequencing (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.