Rapid Onset Action of Salbutamol Versus Formoterol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00900874
First received: May 12, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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 4

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:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by All India Institute of Medical Sciences, New Delhi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 22, 2014