AsthmaPhase 3NCT01095016
A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients
A Phase 3 study testing Meptin swinghaler and Berotec in people with Asthma, run by Taiwan Otsuka Pharm. Co., Ltd at 1 site in Taiwan.
Trial summary
This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Berotec N® Metered Aerosol in stable asthma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Meptin swinghaler and Berotec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2010to Oct 2012
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or females outpatients aged ≥18 years old with uncontrolled or partly controlled asthma; Stability was assessed during the past 14 days the patients remained in the same severity class by 2006 GINA guideline (uncontrolled, partly controlled) and had no acute exacerbations by investigator judgment;
- Pulmonary function test: Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ; Positive result of Brocho-provocation test;
Who cannot join
- Hypersensitivity to β2-agonist or lactose;
- Hospitalization due to asthma during the previous 3 months;
- Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
- Oral or systemic corticosteroids in the previous 4 weeks;
- Inadequately controlled hyperthyroidism;
- Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system or respiratory disease other than asthma(e.g. COPD), or any other disorder which may interfere wth the study evaluations or affect subject safety;
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- Patients receive an investigational drug within 30 days prior to admission to the study;
- Patients with significant alcohol, drug or medication abuse as judged by the investigator;
- Females who are pregnant or breast-feeding; (exception: Females of child-bearing age might be included, if in the opinion of the investigator, they are using adequate contraceptive precautions);
- Subjects who are heavy smoker (more than 10 packs year) or who are smoking within previous 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Cross-over, Active-controlled Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients
This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Berotec N® Metered Aerosol in stable asthma patients
- Conditions
- Asthma
- Being tested
- Meptin swinghaler, Berotec
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meptin swinghalerDrug
- Dose: 10ug/puff, 2 puffs daily
- Frequency: QD (total 20ug/day)
- Treatment duration: 2 days
BerotecDrug
- Dose: 100ug/puff, 2 puffs daily
- Frequency: QD (total 200ug/day)
- Treatment duration: 2 days
| Study group | Role | What they receive |
|---|---|---|
| Meptin swinghaler | Experimental | Not described Receives: Drug: Meptin swinghaler |
| Berotec | Active comparator | Not described Receives: Drug: Berotec |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Forced Expiratory Volume in 1 second (FEV1) value
Measured: 12 months
Secondary outcomes (3)
The change of Peak Expiratory Flow Rate (PEFR)
Measured: 12 months
The change of Forced Vital Capacity (FVC)
Measured: 12 months
Device acceptance
5-point score of evaluation form to test preference on Meptin swinghaler/ Berotec device by investigator or patient
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2012
- Study completionOct 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Otsuka Pharm. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu-Hsiu Chung, MD, Principal investigator, Chang Cung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095016
- Sponsor's protocol ID
- 002-TWB-0901
- Status last verified
- Jan 2013
- First submitted
- 15 Mar 2010
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Cross-over, Active-controlled Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients
- ClinicalTrials.gov ID
- NCT01095016
- Acronym / sponsor ID
- 002-TWB-0901
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Taiwan Otsuka Pharm. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Mar 2010 (estimated)
- 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 an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Berotec N® Metered Aerosol in stable asthma patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meptin swinghaler | Experimental | Drug: Meptin swinghaler |
| Berotec | Active comparator | Drug: Berotec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or females outpatients aged ≥18 years old with uncontrolled or partly controlled asthma; Stability was assessed during the past 14 days the patients remained in the same severity class by 2006 GINA guideline (uncontrolled, partly controlled) and had no acute exacerbations by investigator judgment;
- Pulmonary function test: Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ; Positive result of Brocho-provocation test;
Key exclusion criteria (10 listed)
- Hypersensitivity to β2-agonist or lactose;
- Hospitalization due to asthma during the previous 3 months;
- Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
- Oral or systemic corticosteroids in the previous 4 weeks;
- Inadequately controlled hyperthyroidism;
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 |
|---|---|---|
| Meptin swinghaler* Dose: 10ug/puff, 2 puffs daily * Frequency: QD (total 20ug/day) * Treatment duration: 2 days | Drug | Meptin swinghaler |
| Berotec* Dose: 100ug/puff, 2 puffs daily * Frequency: QD (total 200ug/day) * Treatment duration: 2 days | Drug | Berotec |
Primary outcome
The change of Forced Expiratory Volume in 1 second (FEV1) value
Time frame: 12 months
3 secondary outcomes
The change of Peak Expiratory Flow Rate (PEFR)
Time frame: 12 months
The change of Forced Vital Capacity (FVC)
Time frame: 12 months
Device acceptance
Time frame: 12 months
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 16 Jan 2013.
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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.
Yu-Hsiu Chung, MD principal investigator
Chang Cung 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 3 study testing Meptin swinghaler and Berotec in people with Asthma, run by Taiwan Otsuka Pharm. Co., Ltd 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 10 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 16 Jan 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The change of Forced Expiratory Volume in 1 second (FEV1) value (time frame: 12 months). 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 16 Jan 2013.