Rapid Onset Action of Salbutamol Versus Formoterol - Full Text View

Sponsor:	All India Institute of Medical Sciences, New Delhi
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00900874

Purpose

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.

Condition	Intervention	Phase
Bronchial Asthma	Drug: salbutamol Drug: Formoterol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Formoterol fumarate Levalbuterol hydrochloride Albuterol sulfate Arformoterol Formoterol Arformoterol Tartrate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:

Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Difference in average clinical asthma score between two groups [ Time Frame: 60 min ] [ Designated as safety issue: Yes ]
Adverse effects like tremors, vomiting, palpitation, etc, in two groups [ Time Frame: 60 mins ] [ Designated as safety issue: No ]
Number of patients requiring hospitalization in two groups at end of study period in two groups [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Estimated Enrollment:	78
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Salbutamol + steroid	Drug: salbutamol two puffs (100 microgram each of salbutamol) by MDI and spacer
Active Comparator: 2 Formoterol + steroid	Drug: Formoterol Formoterol 2 puffs (6 µg /puff) by MDI and spacer

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.

Eligibility

Ages Eligible for Study:	5 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900874

Contacts

Contact: S.K Kabra, Dr	9868397540
Contact: Jenish Rajma	9868369498	jenish.rajma@gmail.com

Locations

India
AIIMS	Recruiting
New Delhi, India, 110029
Principal Investigator: Jenish Rajma

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

More Information

No publications provided

Responsible Party:	J.Jenish Rajma, AIIMS
ClinicalTrials.gov Identifier:	NCT00900874 History of Changes
Other Study ID Numbers:	AIIIMS
Study First Received:	May 12, 2009
Last Updated:	May 12, 2009
Health Authority:	India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:

Formoterol
Rapid bronchodilation

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Formoterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012