Efficacy Of Doxophylline As A Sparing Treatment For Inhaled Corticosteroids In Mexican Children With Asthma

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the efficacy of doxophylline as a steroid sparing treatment in Mexican children with asthma treated with medium ir high doses of inhaled corticosteroids (ICS). It is a cross over study in which both groups of patients will receive doxophylline plus a lower steroid dose maintaining the same treatment step according to GINA guidelines, one group will maintain the same treatment dose while the other will start with doxophylline with the lower ICS dose, and by the middle of the study both groups will interchange treatment schemes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Autonoma de Nuevo Leon
• Treatments: Budesonide; Doxofylline; Theophylline

Criteria

Inclusion Criteria:

1. Mexican patients between 6 and 16 years old.

2. Clinical diagnosis of asthma according to the current guidelines of the Global Asthma Initiative (GINA) 2018.

3. Patients with asthma treated with budesonide at medium or high doses during (GINA guidelines´ steps 3 or 4) at least two months before the first study visit. Budesonide medium dose: 200-400 mcg / day (6-11 years) and 400-800 mcg / day (> 12 years). Budesonide high dose: > 400 mcg / day (6-11 years) and > 800 mcg / day (> 12 years).

Exclusion Criteria:

1. Patients <6 or ≥16 years of age.

2. Patients with <16 kg of body weight.

3. Patients who have had an asthma exacerbation that required treatment with systemic corticosteroids (oral, intramuscular or intravenous) during the 2 months prior to the first study visit.

4. Patients who have presented an asthma exacerbation that required hospitalization during the 2 months prior to the first study visit.

5. Any other chronic lung disease that could impair lung function evaluation.

6. Cardiovascular, infectious, metabolic or neoplastic disease that could interfere with the evaluation of the patient.

7. Current use of drugs that interact with doxophylline: other xanthines, ephedrine or other sympathomimetics, erythromycin, troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, two months prior vaccination, propranolol, phenytoin or other anticonvulsants.