AsthmaPhase 4NCT04185129
Comparison Efficacy in Patients With Asthma Using Foster MDI and Relvar Medications
A Phase 4 study testing Foster in people with Asthma, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a randomized study to compare asthma patients using Foster or Relvar. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Foster
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 30 Jun 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosis with asthma with treatment naive
- asthma patients with poor controlled status
Who cannot join
- COPD
- smoking history
- pregnancy
- cardiaovascular disease
- patients with acute respiratory infection
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized study to compare asthma patients using Foster or Relvar.
Read the detailed description
The Global Asthma Association (GAA) and the World Allergy Organization (WAO) recently issued statements stating that the small airway is caused by asthma and chronic obstructive pulmonary disease (COPD). Both pathogenesis and treatment play an important role. The small airway is an airway with diameter less than 2 mm and is one of the main sites where airflow obstruction occurs. Small particles (<2 μm) and large particles are more likely to deposit in the distal airways, and have shown to have better effects on asthma and pulmonary obstruction. At the same time, real-life research has also shown that extra-fine particles provide better asthma control than large particles, and can better improve quality of life.The aim of the study is to compare the efficacy of asthma inhalers between extra-fine particles and non-extra-fine particles.
- Conditions
- Asthma
- Being tested
- Foster
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosterDrug
Also called Relvar
a randomized study for comparison asthma patients using Foster or Relvar. The primary end point is lung function improvement evaluation
| Study group | Role | What they receive |
|---|---|---|
| Foster | Experimental | uncontrolled asthma patients were randomized into Foster treatment group Receives: Drug: Foster |
| Relvar | Active comparator | uncontrolled asthma patients were randomized into Relvar treatment group Receives: Drug: Foster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function improvement
FEV1
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Orient Europharma Co., Ltd.
- Responsible party
- Principal investigator, Shih-Lung Cheng, Far Eastern Memorial Hospital
- Investigators
- Shih-Lung Cheng, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185129
- Sponsor's protocol ID
- Foster 001
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 4 Dec 2019
- 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 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Efficacy in Patients With Asthma Using Foster MDI and Relvar Medications
- ClinicalTrials.gov ID
- NCT04185129
- Acronym / sponsor ID
- Foster 001
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- Orient Europharma Co., Ltd.
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 4 Dec 2019 (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.
This is a randomized study to compare asthma patients using Foster or Relvar.
Detailed description
The Global Asthma Association (GAA) and the World Allergy Organization (WAO) recently issued statements stating that the small airway is caused by asthma and chronic obstructive pulmonary disease (COPD). Both pathogenesis and treatment play an important role. The small airway is an airway with diameter less than 2 mm and is one of the main sites where airflow obstruction occurs. Small particles (<2 μm) and large particles are more likely to deposit in the distal airways, and have shown to have better effects on asthma and pulmonary obstruction. At the same time, real-life research has also shown that extra-fine particles provide better asthma control than large particles, and can better improve quality of life.The aim of the study is to compare the efficacy of asthma inhalers between extra-fine particles and non-extra-fine particles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foster | Experimental | Drug: Fosteruncontrolled asthma patients were randomized into Foster treatment group |
| Relvar | Active comparator | Drug: Fosteruncontrolled asthma patients were randomized into Relvar treatment group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients diagnosis with asthma with treatment naive
- asthma patients with poor controlled status
Key exclusion criteria (5 listed)
- COPD
- smoking history
- pregnancy
- cardiaovascular disease
- patients with acute respiratory infection
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 |
|---|---|---|
| FosterAlso: Relvara randomized study for comparison asthma patients using Foster or Relvar. The primary end point is lung function improvement evaluation | Drug | Foster, Relvar |
Primary outcome
Lung function improvement
Time frame: one year
FEV1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- 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.
Shih-Lung Cheng principal investigator
Far Eastern Memorial Hospital
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 in people with Asthma, run by Far Eastern Memorial Hospital 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: status not confirmed, as of the sponsor's last update on 4 Dec 2019. 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?
Results are not available in the source record.
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?
Lung function improvement (time frame: one year). 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 4 Dec 2019.