Rapid Onset Action of Salbutamol Versus Formoterol
Recruitment status was Recruiting
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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 |
- Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes [ Time Frame: 60 min ] [ Designated as safety issue: No ]
- 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 |
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| Contact: S.K Kabra, Dr | 9868397540 | |
| Contact: Jenish Rajma | 9868369498 | jenish.rajma@gmail.com |
| India | |
| AIIMS | Recruiting |
| New Delhi, India, 110029 | |
| Principal Investigator: Jenish Rajma | |
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 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 June 17, 2013