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Use of azithromycin( an antibiotic) for duration of three months to control symptoms of asthma in children whose symptoms arenot controlled.

Azithromycin for poorly controlled asthma in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019727
Enrollment
120
Registered
2019-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: J454- Moderate persistent asthma Health Condition 2: J455- Severe persistent asthma

Interventions

Intervention1: Azithromycin: Dosages of drug: Azithromycin will be given as 8-12 mg/kg/dose alternate day for 3 months. We will use 250 mg tablet of azithromycin. The numbers of tablet to be given as

Sponsors

Jagat Jeevan ghimire
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children of 5-15 years of age with a diagnosis of poorly controlled asthma. Children already diagnosed with asthma and following up regularly in Pediatric Chest Clinic or Pediatric OPD will be eligible for study. Asthma will be diagnosed clinically based on recurrent episodes of airway obstruction (cough, wheezing and /or breathing difficulty) with multiple triggers and reversibility by history or by positive bronchodilator response. Poorly controlled asthma will be defined as childhood Asthma control test (CACT) score of 11 years of age.

Exclusion criteria

Exclusion criteria: 1. Known allergic to macrolides. 2. Known case of liver, kidney, and/or neurological disease, heart disease. 3. Prolonged QTc interval 4. Received azithromycin within last 2 weeks.

Design outcomes

Primary

MeasureTime frame
change in Asthma Control Test or Childhood asthma control test scoreTimepoint: change in Asthma Control Test or Childhood asthma control test score by score of 2 points in 3 months

Secondary

MeasureTime frame
Average number of exacerbations requiring oral steroids and/or hospitalizationTimepoint: 3 months;Change in Fe NOTimepoint: 3 months;change in parameters of spirometryTimepoint: 3 months;change in percentage of neutrophils in sputumTimepoint: 3 months;Percentage of children positive for bacteria in throat swab/total children where throat swab taken and their sensitivityTimepoint: 3 months;To evaluate Asthma control as per GINA 2018 guidelines.Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Kana Ram Jat

Division of Pediatric Pulmonology. Department of Pediatrics,All India Institute of Medical Sciences

drkanaram@gmail.com98681524266

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 19, 2026