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Role of salbutamol and inhaled steroids in relief of exacerbation of asthma in children

Comparative efficacy of nebulised salbutamol, salbutamol plus budesonide and salbutamol plus fluticasone in the management of acute exacerbation of bronchial asthma in children: A Randomized controlled, triple blind, three arm trial. - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054624
Enrollment
102
Registered
2023-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J452- Mild intermittent asthma Health Condition 2: J453- Mild persistent asthma Health Condition 3: J454- Moderate persistent asthma Health Condition 4: J455- Severe persistent asthma

Interventions

Intervention1: Inhalational Salbutamol plus Budesonide: Salbutamol 2.5mg(for less than 30kg) or 5mg(for more than 30kg) Plus Budesonide (0.5mg) for inhalation. Three Inhalational treatment at the inte

Sponsors

Dr Rachna Pasi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children with known asthma as defined by British Thoracic Society who will be presenting as acute exacerbation of asthma in pediatric OPD/Emergency department 2.Children with past history of two or more episodic wheeze responsive to inhaled beta-2 agonist and now presenting as acute exacerbation of asthma.3.All children presenting with acute exacerbation of asthma whose parents will give written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Children with known asthma who will be presenting as acute exacerbation of asthma but whose parents will not give consent to participate. 2.Children who will be having symptoms of acute life-threatening asthma, chronic respiratory illness and those who took short/long acting b2 agonist or steroids within 6 hours prior to admission. 3.Children who will be having symptoms or radiological evidence of acute alternate diagnosis i.e., bronchopneumonia or pleural effusion. 4.Any deviation from the study treatment protocol necessitated due to clinical situation.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of nebulised salbutamol vs salbutamol plus budesonide vs salbutamol plus fluticasone in management of acute exacerbation of asthma in children using PRAM scoreTimepoint: At 0, 2 and 4 hours from start of treatment

Secondary

MeasureTime frame
1.To assess the effect of nebulised salbutamol vs salbutamol plus budesonide vs salbutamol plus fluticasone in management of acute exacerbation of asthma in children by calculating the improvement in Peak Expiratory Flow rateTimepoint: At 2 and 4hours from start of treatment;2. To assess the short term outcome of nebulised salbutamol vs salbutamol plus fluticasone, salbutamol plus budesonide in management of acute exacerbation of asthma in childrenTimepoint: At 4 hours from start of treatment;3. To assess the long-term level of control of symptoms in these patients on follow up.Timepoint: At 3 months

Countries

India

Contacts

Public ContactDr Arun Babu T

AIIMS Mangalagiri

rachna.pasi@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026