Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PMT-001/10/06
Study information
Scientific title
The efficacy of nebulised procaterol versus nebulised salbutamol for the treatment of moderate acute asthma: a randomised, double-blind, parallel group study
Acronym
Study hypothesis
The efficacy of nebule procaterol in improving peak expiratory flow rate (PEFR) in moderate acute asthma patients is superior to nebule salbutamol.
Ethics approval
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
Study design
Randomised double-blind two-arm parallel group phase III clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Procaterol, salbutamol, methylprednisolone
Primary outcome measures
Difference from baseline in peak expiratory flow rate (PEFR). Measurements performed at 0, 20, 40, 60 and 120 minutes.
Secondary outcome measures
Difference from baseline in asthma score. Measurements performed at 0, 20, 40, 60 and 120 minutes.
Overall trial start date
12/06/2007
Overall trial end date
24/04/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant 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
Recruitment start date
12/06/2007
Recruitment end date
24/04/2008
Locations
Countries of recruitment
Indonesia
Trial participating centre
Department of Pulmonology
Jakarta
13230
Indonesia
Sponsor information
Organisation
Otsuka Indonesia
Sponsor details
Perkantoran Hijau Arkadia
Tower A
3rd Floor
Jl. Letjen T.B. Simatupang Kav. 88
Jakarta
12520
Indonesia
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Otsuka Indonesia
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary