Condition category
Respiratory
Date applied
23/07/2009
Date assigned
05/08/2009
Last edited
05/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hadiarto Mangunegoro

ORCID ID

Contact details

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

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

http://www.otsuka.co.id/

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

Publication citations

Additional files

Editorial Notes