Nebulized Procaterol Versus Nebule Salbutamol for the Treatment of Moderate Acute Asthma
The Efficacy of Nebulized Procaterol Versus Nebulized Salbutamol for the Treatment of Moderate Acute Asthma: a Randomized, Double-blind, Parallel Group Study
1 other identifier
interventional
140
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2007
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 5, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedOctober 7, 2009
October 1, 2009
10 months
October 5, 2009
October 6, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Difference 5% from baseline in peak expiratory flow rate (PEFR)
3 times every 20 minutes (at 0, 20 and 40 minutes)
Secondary Outcomes (1)
Difference 5% from baseline in asthma score
3 times every 20 minutes (at 0, 20 and 40 minutes)
Study Arms (2)
Procaterol
EXPERIMENTALProcaterol 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 COMPARATORSalbultamol 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant and lactating women
- Smokers
- Patients with heart disease, hyperthyroidism, diabetes mellitus, COPD or other chronic diseases
- Patients with signs of severe infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Indonesia/ Persahabatan Hospital
Jakarta, Indonesia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hadiarto Mangunnegoro, MD
Department of Pulmonology and Respiratory Medicine, Faculty of Medicine University of Indonesia/ Persahabatan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2009
First Posted
October 7, 2009
Study Start
June 1, 2007
Primary Completion
April 1, 2008
Study Completion
August 1, 2008
Last Updated
October 7, 2009
Record last verified: 2009-10