Efficacy and safety of regular treatment with procaterol and budesonide inhalation suspension for young children with moderate persistent asthma

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2010
INTERVENTION: GROUP B + P (budesonide + procaterol) Phase 1: 4 weeks Inhalation of the mixture of procaterol(0.3ml for >15kg, 0.15ml for <15kg) and budesonide inhalation suspension(0.25mg), twice a day, using jet nebulizer (PARI TurboBOY N,PALI LC Plus Nebulizer) Phase 2: 4 weeks after phase 1 Inhalation of budesonide inhalation suspension(0.25mg), twice a day, using jet nebulizer (PARI TurboBOY N,PALI LC Plus Nebulizer) GROUP B (budesonide) Phase 1: 4 weeks Budesonide inhalation suspension (0.25 mg), twice a day, using jet nebulizer (PARI TurboBOY N,PALI LC Plus Nebulizer) Phase 2: 4 weeks after phase 1 Continue method of Phase 1 CONDITION: Bronchial Asthma PRIMARY OUTCOME: Symptom free days (Sympton is cough and wheezing and dyspnea and sleep disturbance) SECONDARY OUTCOME: 1.Score of symptom (base on asthma diary); 2.Frequency of inhaled short acting beta 2 agonist (SABA) use; 3.Unscheduled hospital visits and emergency room visits because of asthma exacerbation; 4.Count of blood eosinophil at baseline and end of phase 1 (end of phase 2,if possible); 5.Level of blood serum cortisol at baseline and end of phase 1 (end of phase 2,if possible); 6.QOL test at baseline and end of phase 1 (end of phase 2,if possible); 7.exhaled nitric oxide (only the child can be examined); 8.PEFR:morning and evening (only the child can be examined); 9.Adverse events INCLUSION CRITERIA: 1.Children with persistent asthma ‐Age : children over six months under five years of age ‐Severity : moderate according to the criteria of JPGL 2008 2.Children who (whose parents) have given informed consent for participation in the present study.
Epistemonikos ID: 29010f30eea98154bdd4da3287c5ba18ef05dfef
First added on: Aug 22, 2024