Moderate Acute AsthmaPhase 3NCT00990847
Nebulized Procaterol Versus Nebule Salbutamol for the Treatment of Moderate Acute Asthma
A Phase 3 study testing Procaterol, Salbultamol in people with Moderate Acute Asthma, run by PT Otsuka Indonesia at 1 site in Indonesia.
Trial summary
The purpose of this study is to compare the efficacy and safety of nebule procaterol with nebule salbutamol in the treatment of moderate acute asthma. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Moderate Acute Asthma
- What is being tested?
- Procaterol, Salbultamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2007to Aug 2008
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with moderate acute asthma according to Global Initiative for Asthma (GINA) 1998 (Appendix 1). Patients with moderate acute asthma according to Modified Global Initiative for Asthma (GINA) 1998 (Patients with asthma score 5 - 11; PEFR ≤ 80% predicted)
- Patients of both gender aged 15 to 60 years
- Patients still have the ability to undergo examinations and give written informed consent
Who cannot join
- Pregnant and lactating women
- Smokers
- Patients with heart disease, hyperthyroidism, diabetes mellitus, COPD or other chronic diseases
- Patients with signs of severe infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Nebulized Procaterol Versus Nebulized Salbutamol for the Treatment of Moderate Acute Asthma: a Randomized, Double-blind, Parallel Group Study
The purpose of this study is to compare the efficacy and safety of nebule procaterol with nebule salbutamol in the treatment of moderate acute asthma.
- Conditions
- Moderate Acute Asthma
- Being tested
- Procaterol, Salbultamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procaterol, SalbultamolDrug
| Study group | Role | What they receive |
|---|---|---|
| Procaterol | Experimental | Procaterol inhalation solution 50 micro g per 0.5 mL diluted in 2mL of NaCl 0.9%, so that the volume of the inhalation solution will be similar to that of the comparator drug. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes. Receives: Drug: Procaterol, Salbultamol |
| Salbultamol | Active comparator | Salbultamol inhalation solution for nebulization containing 2.5 mg in 2.5 mL aqueous solution. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes. Receives: Drug: Procaterol, Salbultamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference 5% from baseline in peak expiratory flow rate (PEFR)
Measured: 3 times every 20 minutes (at 0, 20 and 40 minutes)
Secondary outcomes (1)
Difference 5% from baseline in asthma score
Measured: 3 times every 20 minutes (at 0, 20 and 40 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Acute 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Otsuka Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hadiarto Mangunnegoro, MD, Principal investigator, Department of Pulmonology and Respiratory Medicine, Faculty of Medicine University of Indonesia/ Persahabatan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990847
- Sponsor's protocol ID
- 002-IOA-0601
- Status last verified
- Oct 2009
- First submitted
- 5 Oct 2009
- Last updated
- 7 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Nebulized Procaterol Versus Nebulized Salbutamol for the Treatment of Moderate Acute Asthma: a Randomized, Double-blind, Parallel Group Study
- ClinicalTrials.gov ID
- NCT00990847
- Acronym / sponsor ID
- 002-IOA-0601
- Conditions
- Moderate Acute Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- PT Otsuka IndonesiaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 7 Oct 2009 (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.
The purpose of this study is to compare the efficacy and safety of nebule procaterol with nebule salbutamol in the treatment of moderate acute asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procaterol | Experimental | Drug: Procaterol, SalbultamolProcaterol inhalation solution 50 micro g per 0.5 mL diluted in 2mL of NaCl 0.9%, so that the volume of the inhalation solution will be similar to that of the comparator drug. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes. |
| Salbultamol | Active comparator | Drug: Procaterol, SalbultamolSalbultamol inhalation solution for nebulization containing 2.5 mg in 2.5 mL aqueous solution. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with moderate acute asthma according to Global Initiative for Asthma (GINA) 1998 (Appendix 1). Patients with moderate acute asthma according to Modified Global Initiative for Asthma (GINA) 1998 (Patients with asthma score 5 - 11; PEFR ≤ 80% predicted)
- Patients of both gender aged 15 to 60 years
- Patients still have the ability to undergo examinations and give written informed consent
Key exclusion criteria (4 listed)
- Pregnant and lactating women
- Smokers
- Patients with heart disease, hyperthyroidism, diabetes mellitus, COPD or other chronic diseases
- Patients with signs of severe infections
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 |
|---|---|---|
| Procaterol, Salbultamol | Drug | Procaterol, Salbultamol |
Primary outcome
Difference 5% from baseline in peak expiratory flow rate (PEFR)
Time frame: 3 times every 20 minutes (at 0, 20 and 40 minutes)
1 secondary outcome
Difference 5% from baseline in asthma score
Time frame: 3 times every 20 minutes (at 0, 20 and 40 minutes)
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 7 Oct 2009.
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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.
Hadiarto Mangunnegoro, MD principal investigator
Department of Pulmonology and Respiratory Medicine, Faculty of Medicine University of Indonesia/ Persahabatan 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 Procaterol, Salbultamol in people with Moderate Acute Asthma, run by PT Otsuka Indonesia at 1 site in Indonesia.
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 3 inclusion and 4 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 7 Oct 2009. 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 Indonesia. 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?
Difference 5% from baseline in peak expiratory flow rate (PEFR) (time frame: 3 times every 20 minutes (at 0, 20 and 40 minutes)). 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 7 Oct 2009.