Nocturnal TLA for Severe Allergic Asthma After Withdrawal of Omalizumab Therapy

June 8, 2021 updated by: Chun-Hua Wang, MD, Chang Gung Memorial Hospital

Nocturnal Temperature Controlled Laminar Airflow Device, Airsonett, for Treating Severe Allergic Asthma After Withdrawal of Omalizumab therapyT

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Willing to sign a written consent form
  2. Male and female subjects were diagnosed severe allergic asthma and received omalizumab as add-on therapy for more 4 than months and had stable asthma control.
  3. Men and women over the age of 20 and less than 80 year-old
  4. Accept application of TLA or not after withdrawal of omalizumab therapy
  5. Positive reaction of specific IgE (Phadiatop) for one or more than on indoor allergens.

Exclusion Criteria:

  1. Having an exacerbation within 4 weeks before entry the study
  2. Using immunosuppressants within 3 months of the first visit
  3. Having recent upper airway infection or systemic corticosteroid usage within 4 weeks
  4. Bronchiectasis
  5. Active pulmonary tuberculsis
  6. COPD
  7. Cystic fibrosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: TLA device
These patients will be withdrawal of omalizumab treatment and receive nocturnal temperature controlled laminar flow device at nighttime for 12 months.
Device: Nocturnal Temperature Controlled Laminar Flow Device
Record of the time to first asthma exacerbation, lung function and exhaled NO level
Placebo Comparator: None device
These patients will be withdrawal of omalizumab treatment and do not receive TLA device for 12 months.
Other: None Device
Record of the time to first asthma exacerbation, lung function and exhaled NO level

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The first time of asthma exacerbation
Time Frame: Through study completion of 48 weeks
Time to the first significant asthma exacerbation or ER visit or hospitalization will be also recorded.
Through study completion of 48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spirometry
Time Frame: at 0, 4, 12, 24, 36, and 48 weeks after enrollment
Pulmonary function testing, including FVC and FEV1
at 0, 4, 12, 24, 36, and 48 weeks after enrollment
Exhaled nitric oxide
Time Frame: at 0, 4, 12, 24, 36, and 48 weeks after enrollment
measured level is ppb.
at 0, 4, 12, 24, 36, and 48 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chun-Hua Wang, MD, Department of Thoracic Medicine, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201600573A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

N/D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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