Clinical trial NCT00504062 (phase 3, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: budesonide, fluticasone
SMILES: COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed written informed consent by patient's legal representative; when
             possible a signed written informed consent should be obtained from the patient
             themselves

          -  Patients diagnosed as having bronchial asthma regardless of type of asthma i.e.
             perennial or seasonal, atopic or non-atopic

          -  Males/females 5-15 yrs old who are able to experience to inhale with turbuhaler and
             diskus. the investigator will check whether the patient can inhale appropriately using
             training devises and "Turbuhaler trainer"

          -  Patients with bronchial asthma who require treatment with inhaled steroids (patients
             with drug therapy, in whom asthma is poorly controlled)

          -  Patients who are already treated with inhaled GCS should have at least 3 months
             prehistory of asthma before obtaining the written informed consent

        Exclusion Criteria:

          -  Use of regular(more than 3 days) systemic (oral, intravenous or intramuscular)
             steroids within 30 days before the observation period

          -  The daily dose of inhaled GCS within 30 days before the observation period for the
             patients who are already treated with inhaled GCS is beyond fluticasone propionate
             (FP) 200 µg/day or beclomethasone dipropionate (BDP) 200 μg/day.

          -  Respiratory infections that, in the opinion of the investigator(s), may affect the
             efficacy evaluation e.g. lower airways infection such as pneumonia, infection with no
             available effective antimicrobial drugs or with deep seated mycosis within 30 days
             before the observation period.

          -  Concurrent serious diseases of liver, kidney, heart or other complications which, in
             the opinion of the investigator(s), may either put the patient at risk because of
             participation in the study, or may influence the results of the study, or the
             patient's ability to participate in the study

          -  Contra-indications (e.g., known or suspected allergy) to budesonide, fluticasone or
             lactose contained in the investigational product

          -  Participation in another clinical study within 12 weeks prior to the observation
             period or during the study

          -  Previous enrolment in the present study

          -  Current use of budesonide turbuhaler

          -  Pregnancy or possible pregnancy, or planning to be pregnant during the study period

          -  Patients whose legal representative/caregiver is involved in the planning and conduct
             of the study (applies to both AstraZeneca staff or staff at the study site)

          -  Other subjects who are considered inappropriate to participate in this study as judged
             by the investigator