Nebulised procaterol versus nebulised salbutamol for the treatment of moderate acute asthma

ISRCTN ISRCTN25669625
DOI https://doi.org/10.1186/ISRCTN25669625
Secondary identifying numbers PMT-001/10/06
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

Department of Pulmonology
Faculty of Medicine
University of Indonesia
Persahabatan Hospital
Jl. Persahabatan Raya No. 1
Jakarta
13230
Indonesia

Study information

Study designRandomised double-blind two-arm parallel group phase III clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe efficacy of nebulised procaterol versus nebulised salbutamol for the treatment of moderate acute asthma: a randomised, double-blind, parallel group study
Study objectivesThe 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) studiedModerate acute asthma
InterventionTreatment 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Procaterol, salbutamol, methylprednisolone
Primary outcome measureDifference from baseline in peak expiratory flow rate (PEFR). Measurements performed at 0, 20, 40, 60 and 120 minutes.
Secondary outcome measuresDifference from baseline in asthma score. Measurements performed at 0, 20, 40, 60 and 120 minutes.
Overall study start date12/06/2007
Completion date24/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants140
Key inclusion criteria1. 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 criteria1. 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 enrolment12/06/2007
Date of final enrolment24/04/2008

Locations

Countries of recruitment

  • Indonesia

Study participating centre

Department of Pulmonology
Jakarta
13230
Indonesia

Sponsor information

Otsuka Indonesia
Industry

Perkantoran Hijau Arkadia
Tower A, 3rd Floor
Jl. Letjen T.B. Simatupang Kav. 88
Jakarta
12520
Indonesia

Website http://www.otsuka.co.id/
ROR logo "ROR" https://ror.org/01ambd593

Funders

Funder type

Industry

Otsuka Indonesia

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan