AsthmaPhase 4NCT01091337
Comparative Study on the Efficacy and Safety of Procaterol Versus Salbutamol Given Via Metered Dose Inhaler With Spacer in the Management of Acute Asthma Attack in the Emergency Room
A Phase 4 study testing Procaterol and Salbutamol in people with Asthma, run by Otsuka Pharmaceutical, Inc., Philippines at 1 site in Philippines.
Trial summary
To compare the efficacy and safety of inhaled procaterol (Meptin Air) versus inhaled salbutamol as metered dose inhaler (MDI) reliever of acute exacerbation of asthma not in imminent respiratory failure. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Procaterol and Salbutamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePhilippines
- Study dates
- May 2006to Sep 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged 20 years old and above who are brought to the Emergency Room (ER) with acute bronchospasm
- Diagnosed cases of bronchial asthma based on history, physical examination and pulmonary function test
- Patients maintained on inhaled steroids who have no active medical problems (such as pulmonary TB, cardiac and renal diseases) aside from asthma
- Presence of known risk factors for asthma mortality does not disqualify patients from the study unless they are in impending respiratory failure
- All patients must sign the informed consent form
Who cannot join
- Patients who are in respiratory distress consistent with severe exacerbation requiring intensive care hospital admission
- Who had intake of oral bronchodilator 6 hrs prior to consult
- Who had intake of oral steroids within the last 24 hrs
- Those with positive history of allergy and hypersensitivity to procaterol and salbutamol
- Patients who are diagnosed or clinically suspected to have COPD (ever-smokers with >10 pack-years smoking history or those exposed to workplaces where there is a heavy smoke load)
- Presence of concurrent disease/diseases that may aggravate asthma thereby delaying bronchodilator response (e.g., pneumonia, pulmonary congestion and others)
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- Patients with other medical conditions which are serious enough to warrant immediate concurrent therapy during the 1 hour study and/or whose condition can be adversely affected by the treatment given (like uncontrolled diabetes, renal failure and hepatic insufficiency)
- The NIH Working Group on Asthma and Pregnancy has recommended that pregnant asthmatics are treated as aggressively as non-pregnant patients particularly during acute asthmatic attack. , Bronchodilators (except for epinephrine which is not in this study) have been found safe in pregnancy with a risk class of B and C. For these reasons, pregnancy by itself is not an exclusion criterion in this study and a pregnancy test will not be required for those who are in the childbearing age group. Requiring the test will unnecessarily delay the treatment for acute asthma. However, those who are suspected to be suffering from pregnancy-related complications like vaginal bleeding, premature labor, pre-eclampsia and others, are excluded.
- Severe Acute Asthma Attack, a reason for patient exclusion, shall be defined in this study as the presence of any one of the following criteria:
- Severe asthma with a lack of response to initial therapy in the emergency department or worsening asthma despite adequate therapy.
- Presence of confusion, drowsiness, other signs of impending respiratory arrest, or loss of consciousness
- Wood-Downe's clinical asthma scoring score of >5 (see table 2 below)
- Any patient who is currently participating in other drug trials and/or having participated in other drug trials for less than 1 month of termination of the trial are excluded
- Patients who have previously participated in this study are excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on the Efficacy and Safety of Procaterol vs Salbutamol Given Via Metered Dose Inhaler With Spacer in the Management of Acute Asthma Attack in the Emergency Room
To compare the efficacy and safety of inhaled procaterol (Meptin Air) versus inhaled salbutamol as metered dose inhaler (MDI) reliever of acute exacerbation of asthma not in imminent respiratory failure.
- Conditions
- Asthma
- Being tested
- Procaterol, Salbutamol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcaterolDrug
Also called Meptin Air
Procaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes
+ Hydrocortisone, 100 mg IV shall be given immediately at start of treatment
SalbutamolDrug
Also called Ventolin Inhaler
Salbutamol(Ventolin Inhaler) MDI, 40 ug or 4 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment
| Study group | Role | What they receive |
|---|---|---|
| Procaterol | Experimental | Procaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes
+ Hydrocortisone, 100 mg IV shall be given immediately at start of treatment Receives: Drug: Procaterol |
| Salbutamol | Active comparator | Salbutamol(Ventolin Inhaler) MDI, 40 ug or 4 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment Receives: Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the bronchodilator efficacy of inhaled procaterol (Meptin Air) vs. inhaled salbutamol used as MDI reliever of acute exacerbation of asthma in the ER.
Measured: < 12 hours
Secondary outcomes (1)
To evaluate the safety of procaterol MDI (Meptin Air) versus salbutamol MDI in the management of acute exacerbation of asthma in terms of adverse side effects such as palpitations, tachycardia, tremor, and hypokalemia.
Measured: < 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMay 2006
- Primary completionSep 2009
- Study completionSep 2009
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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical, Inc., Philippines
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Camilo Roa, MD, Principal investigator, Philippine General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091337
- Sponsor's protocol ID
- KOIAA-MPT-2005-01
- Status last verified
- Mar 2010
- First submitted
- 5 Mar 2010
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Efficacy and Safety of Procaterol vs Salbutamol Given Via Metered Dose Inhaler With Spacer in the Management of Acute Asthma Attack in the Emergency Room
- ClinicalTrials.gov ID
- NCT01091337
- Acronym / sponsor ID
- KOIAA-MPT-2005-01
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical, Inc., PhilippinesIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 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.
To compare the efficacy and safety of inhaled procaterol (Meptin Air) versus inhaled salbutamol as metered dose inhaler (MDI) reliever of acute exacerbation of asthma not in imminent respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procaterol | Experimental | Drug: ProcaterolProcaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment |
| Salbutamol | Active comparator | Drug: SalbutamolSalbutamol(Ventolin Inhaler) MDI, 40 ug or 4 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 20 years old and above who are brought to the Emergency Room (ER) with acute bronchospasm
- Diagnosed cases of bronchial asthma based on history, physical examination and pulmonary function test
- Patients maintained on inhaled steroids who have no active medical problems (such as pulmonary TB, cardiac and renal diseases) aside from asthma
- Presence of known risk factors for asthma mortality does not disqualify patients from the study unless they are in impending respiratory failure
- All patients must sign the informed consent form
Key exclusion criteria (14 listed)
- Patients who are in respiratory distress consistent with severe exacerbation requiring intensive care hospital admission
- Who had intake of oral bronchodilator 6 hrs prior to consult
- Who had intake of oral steroids within the last 24 hrs
- Those with positive history of allergy and hypersensitivity to procaterol and salbutamol
- Patients who are diagnosed or clinically suspected to have COPD (ever-smokers with >10 pack-years smoking history or those exposed to workplaces where there is a heavy smoke load)
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 |
|---|---|---|
| ProcaterolAlso: Meptin AirProcaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment | Drug | Procaterol |
| SalbutamolAlso: Ventolin InhalerSalbutamol(Ventolin Inhaler) MDI, 40 ug or 4 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment | Drug | Salbutamol |
Primary outcome
To evaluate the bronchodilator efficacy of inhaled procaterol (Meptin Air) vs. inhaled salbutamol used as MDI reliever of acute exacerbation of asthma in the ER.
Time frame: < 12 hours
1 secondary outcome
To evaluate the safety of procaterol MDI (Meptin Air) versus salbutamol MDI in the management of acute exacerbation of asthma in terms of adverse side effects such as palpitations, tachycardia, tremor, and hypokalemia.
Time frame: < 12 hours
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 24 Mar 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.
Camilo Roa, MD principal investigator
Philippine General 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 Procaterol and Salbutamol in people with Asthma, run by Otsuka Pharmaceutical, Inc., Philippines at 1 site in Philippines.
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 14 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 24 Mar 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 Philippines. 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?
To evaluate the bronchodilator efficacy of inhaled procaterol (Meptin Air) vs. inhaled salbutamol used as MDI reliever of acute exacerbation of asthma in the ER. (time frame: < 12 hours). 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 24 Mar 2010.