Nebulised procaterol versus nebulised salbutamol for the treatment of moderate acute asthma
| ISRCTN | ISRCTN25669625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25669625 |
| Protocol serial number | PMT-001/10/06 |
| Sponsor | Otsuka Indonesia |
| Funder | Otsuka Indonesia |
- Submission date
- 23/07/2009
- Registration date
- 05/08/2009
- Last edited
- 05/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hadiarto Mangunegoro
Scientific
Scientific
Department of Pulmonology
Faculty of Medicine
University of Indonesia
Persahabatan Hospital
Jl. Persahabatan Raya No. 1
Jakarta
13230
Indonesia
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind two-arm parallel group phase III clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The efficacy of nebulised procaterol versus nebulised salbutamol for the treatment of moderate acute asthma: a randomised, double-blind, parallel group study |
| Study objectives | The efficacy of nebule procaterol in improving peak expiratory flow rate (PEFR) in moderate acute asthma patients is superior to nebule salbutamol. |
| Ethics approval(s) | 1. Ethical clearance and registration in local (Indonesian) regulatory authority approved 7th March 2006 2. Ethics Committee of the Medical Research Ethics of the Faculty of Medicine, University of Indonesia approved on 9th October 2006 |
| Health condition(s) or problem(s) studied | Moderate acute asthma |
| Intervention | Treatment allocation was according to block randomisation using random permuted blocks of size 4. Patients received either one ampule of procaterol, diluted with 2 ml of normal saline, or one ampule of salbutamol three times every 20 minutes (at 0, 20 and 40 minutes). Both drugs were administered via jet-type nebuliser (Pulmoaid™). The PEFR was measured 20, 40, 60 and 120 minutes. At the same time, vital signs, asthma score and adverse events were evaluated. At 120 minutes, the blood gas analysis and the electrocardiogram (ECG) were repeated. Then, the patient was observed for adverse event(s) that might occur until 280 minutes. Afterwards, the patient was discharged from the study and received 6 tablets of bronchodilator (salbutamol) and 6 tablets of corticosteroid (methylprednisolone). |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Procaterol, salbutamol, methylprednisolone |
| Primary outcome measure(s) |
Difference from baseline in peak expiratory flow rate (PEFR). Measurements performed at 0, 20, 40, 60 and 120 minutes. |
| Key secondary outcome measure(s) |
Difference from baseline in asthma score. Measurements performed at 0, 20, 40, 60 and 120 minutes. |
| Completion date | 24/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 140 |
| Key inclusion criteria | 1. Patients with moderate acute asthma according to Global Initiative for Asthma (GINA) 1998 (patients with asthma score 5 to 11; PEFR less than or same 80% predicted) 2. Patients of both genders, aged 15 to 60 years 3. Patients still have the ability to undergo examinations and give written informed consent |
| Key exclusion criteria | 1. Pregnant and lactating women 2. Smokers 3. Patients with heart disease, hyperthyroidism, diabetes mellitus, chronic obstructive pulmonary disease (COPD) or other chronic diseases 4. Patients with signs of severe infections |
| Date of first enrolment | 12/06/2007 |
| Date of final enrolment | 24/04/2008 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Department of Pulmonology
Jakarta
13230
Indonesia
13230
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
