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Rapid Onset Action of Salbutamol Versus Formoterol

Primary Purpose

Bronchial Asthma

Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
salbutamol
Formoterol
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchial Asthma focused on measuring Formoterol, Rapid bronchodilation

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or Pediatric OPD

  2. Mild exacerbation will be defined as:

    • children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration
    • no chest indrawing
    • no difficulty in speech
    • clinical asthma score (or pulmonary index score-annexure 1) between 6-9

Exclusion Criteria:

  1. Children with life threatening asthma detected by presence of any of the following:

    • severe chest indrawing
    • cyanosis
    • irregular respiration
    • altered sensorium
  2. Children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma
  3. If child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol)
  4. Child not able to perform spirometry
  5. Parents refusing to give consent

Sites / Locations

  • AIIMSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Salbutamol + steroid

Formoterol + steroid

Outcomes

Primary Outcome Measures

Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes

Secondary Outcome Measures

Difference in average clinical asthma score between two groups
Adverse effects like tremors, vomiting, palpitation, etc, in two groups
Number of patients requiring hospitalization in two groups at end of study period in two groups

Full Information

First Posted
May 12, 2009
Last Updated
May 12, 2009
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT00900874
Brief Title
Rapid Onset Action of Salbutamol Versus Formoterol
Official Title
Comparing Rapid Bronchodilatory Effect of Formoterol and Salbutamol in Children Between 5-15 Years With Mild to Moderate Acute Exacerbation of Asthma- A Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e., the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1, 5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute exacerbation of asthma.
Detailed Description
It is desirable to have a single MDI that can be used as both LABA and SABA. There are few studies involving few children on use of formoterol that shows rapid bronchodilatation in children with asthma and no study that used it as rescue drug in children with acute exacerbation of asthma. The purpose of the present study is to evaluate whether the rapid bronchodilatory effect of formoterol is similar to that of salbutamol in children of 5-15 years with mild exacerbation of asthma. Children will receive either salbutamol or formoterol by MDI. Participants will be explained about the study, spirometry and inhalation of medicine with MDI and spacer. Children will receive two puffs (100 microgram each of salbutamol) or Formoterol 2 puffs (6µg /puff) by MDI and spacer. Each child will be explained about the inhalation technique by using a MDI of placebo. After shaking the MDI it will be attached to spacer (700ml volume) and actuated. Child will be asked to take 5 tidal breaths. Another puff will be given by similar method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
Formoterol, Rapid bronchodilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Salbutamol + steroid
Arm Title
2
Arm Type
Active Comparator
Arm Description
Formoterol + steroid
Intervention Type
Drug
Intervention Name(s)
salbutamol
Intervention Description
two puffs (100 microgram each of salbutamol) by MDI and spacer
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Description
Formoterol 2 puffs (6 µg /puff) by MDI and spacer
Primary Outcome Measure Information:
Title
Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes
Time Frame
60 min
Secondary Outcome Measure Information:
Title
Difference in average clinical asthma score between two groups
Time Frame
60 min
Title
Adverse effects like tremors, vomiting, palpitation, etc, in two groups
Time Frame
60 mins
Title
Number of patients requiring hospitalization in two groups at end of study period in two groups
Time Frame
60 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or Pediatric OPD Mild exacerbation will be defined as: children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration no chest indrawing no difficulty in speech clinical asthma score (or pulmonary index score-annexure 1) between 6-9 Exclusion Criteria: Children with life threatening asthma detected by presence of any of the following: severe chest indrawing cyanosis irregular respiration altered sensorium Children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma If child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol) Child not able to perform spirometry Parents refusing to give consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
S.K Kabra, Dr
Phone
9868397540
First Name & Middle Initial & Last Name or Official Title & Degree
Jenish Rajma
Phone
9868369498
Email
jenish.rajma@gmail.com
Facility Information:
Facility Name
AIIMS
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenish Rajma

12. IPD Sharing Statement

Citations:
PubMed Identifier
22394648
Citation
Arun JJ, Lodha R, Kabra SK. Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial. BMC Pediatr. 2012 Mar 7;12:21. doi: 10.1186/1471-2431-12-21.
Results Reference
derived

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Rapid Onset Action of Salbutamol Versus Formoterol

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