AsthmaPhase 3NCT01076322
A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients
A Phase 3 study testing Meptin® Swinghaler and Ventolin® MDI 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 Ventolin® MDI in stable asthma patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Meptin® Swinghaler and Ventolin® MDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Jun 2010
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or females outpatients aged ≥ 16 years old with stable mild to moderate persistent asthma; Stability was assessed the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days;
- Pulmonary function test:
- Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ;
- Positive result of Broncho-provocation test (PC20 ≤ 32 mg/ml) before the study.
- Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;
Who cannot join
- Hypersensitivity to β2-agonist or lactose;
- Hospitalization due to asthma during the previous 3months;
- Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
- Oral or systemic corticosteroids in the previous 4weeks;
- Inadequately controlled hyperthyroidism;
- Severe hepatic or renal or cardiovascular disease as judged by the investigator;
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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).
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Ventolin® MDI in stable asthma patients.
- Conditions
- Asthma
- Being tested
- Meptin® Swinghaler, Ventolin® MDI
- 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
Also called Meptin® Swinghaler®, Procaterol HCL, Ventolin® MDI, Salbutamol sulfate
Meptin® Swinghaler®
- Ingredient: Procaterol HCL
- Dosage form: 10g/puff
- Dose(s): 10g
- Dosing schedule: 20g (total 20g)
Ventolin® MDIDrug
Ventolin® MDI
- Ingredient: Salbutamol sulfate
- Dosage form: 100g/puff
- Dose(s): 100g
- Dosing schedule: 200g (total 200g)
| Study group | Role | What they receive |
|---|---|---|
| Treatment-A sequence | Experimental | Meptin® Swinghaler / Ventolin® MDI Receives: Drug: Meptin® Swinghaler; Drug: Ventolin® MDI |
| Treatment-B sequence | Experimental | Ventolin® MDI / Meptin® Swinghaler Receives: Drug: Meptin® Swinghaler; Drug: Ventolin® MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Forced Expiratory Volume in 1 second (FEV1) value.
Measured: 2 days
Secondary outcomes (7)
The change in sGaw
Measured: 2 days
The changes in IOS parameters (R, X and RF)
Measured: 2 days
The change in Peak Expiratory Flow Rate (PEFR)
Measured: 2 days
The change in Forced Vital Capacity (FVC)
Measured: 2 days
The change in Oxygen Saturation (SpO2)
Measured: 2 days
The change in Borg scale
Measured: 2 days
Device acceptance
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionJun 2010
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
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Otsuka Pharm. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ping-Hung Kuo, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076322
- Sponsor's protocol ID
- 002-TWB-0801
- Status last verified
- Feb 2010
- First submitted
- 24 Feb 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients
- ClinicalTrials.gov ID
- NCT01076322
- Acronym / sponsor ID
- 002-TWB-0801
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Taiwan Otsuka Pharm. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Feb 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 Ventolin® MDI 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 |
|---|---|---|
| Treatment-A sequence | Experimental | Drug: Meptin® Swinghaler, Drug: Ventolin® MDIMeptin® Swinghaler / Ventolin® MDI |
| Treatment-B sequence | Experimental | Drug: Meptin® Swinghaler, Drug: Ventolin® MDIVentolin® MDI / Meptin® Swinghaler |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or females outpatients aged ≥ 16 years old with stable mild to moderate persistent asthma; Stability was assessed the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days;
- Pulmonary function test:
- Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;
Key exclusion criteria (9 listed)
- Hypersensitivity to β2-agonist or lactose;
- Hospitalization due to asthma during the previous 3months;
- Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
- Oral or systemic corticosteroids in the previous 4weeks;
- 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® SwinghalerAlso: Meptin® Swinghaler®, Procaterol HCL, Ventolin® MDI, Salbutamol sulfateMeptin® Swinghaler® * Ingredient: Procaterol HCL * Dosage form: 10g/puff * Dose(s): 10g * Dosing schedule: 20g (total 20g) | Drug | Treatment-A sequence, Treatment-B sequence |
| Ventolin® MDIVentolin® MDI * Ingredient: Salbutamol sulfate * Dosage form: 100g/puff * Dose(s): 100g * Dosing schedule: 200g (total 200g) | Drug | Treatment-A sequence, Treatment-B sequence |
Primary outcome
The change in Forced Expiratory Volume in 1 second (FEV1) value.
Time frame: 2 days
7 secondary outcomes
The change in sGaw
Time frame: 2 days
The changes in IOS parameters (R, X and RF)
Time frame: 2 days
The change in Peak Expiratory Flow Rate (PEFR)
Time frame: 2 days
The change in Forced Vital Capacity (FVC)
Time frame: 2 days
The change in Oxygen Saturation (SpO2)
Time frame: 2 days
The change in Borg scale
Time frame: 2 days
Device acceptance
Time frame: 2 days
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 12 Aug 2010.
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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.
Ping-Hung Kuo, MD principal investigator
National Taiwan University 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 Ventolin® MDI 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 5 inclusion and 9 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 12 Aug 2010. 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 in Forced Expiratory Volume in 1 second (FEV1) value. (time frame: 2 days). 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 12 Aug 2010.