Clinical trial NCT02063139 (phase 2, status: completed)
Conditions: mild persistent asthma
ICD codes: J45.30, J45.31, J45.32
Drugs: flutiform 50/5 ug (2 puffs bid) pmdi, fluticasone 50 ug (2puffs bid) pmdi, beclometasone autohaler 50 ug (2 puffs bid)
SMILES: [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, [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria

        Subjects to be included in the study are those who meet all of the following criteria:

          1. Male and Female subjects 5 to <12 years old. Female subjects must be pre-menarche to
             be eligible.

          2. Subjects must be pre-adolescent without any signs of puberty (acc. to Tanner scale).

          3. Subjects are in normal range for their age in height and weight. Weight and height
             measurements should fall within the percentile range 3-97-% of normal values for age
             according to Danish growth charts.

          4. Known history of mild intermittent or persistent reversible asthma for ≥ 3 months
             prior to the screening visit.

          5. Require:

               1. only inhaled SABA therapy (e.g. Bricanyl Turbuhaler) on an as required basis,
                  and/or

               2. Regular non-ICS controller medications for asthma (e.g., cromones or leukotriene
                  receptor antagonists) at a stable dose for ≥ 3 months prior to the screening
                  visit.

          6. No ICS for >2 weeks prior to the screening visit.

          7. Demonstrates adequate spirometry technique and able to use a home PEFR meter.

          8. Demonstrated FEV1 of ≥ 80% predicted value at visit 1following appropriate withholding
             of asthma medications (if applicable) (no SABA use within 6 hours of the PFT).

          9. Demonstrated satisfactory technique in the use of the pMDI plus spacer and Autohaler
             devices.

         10. Must be continent of urine and willing to perform (with parental/guardian help)
             overnight urine collections.

         11. Willing and able to complete morning and evening PEFR measures with the help of a
             parent or guardian, if necessary, and attend all study visits.

         12. Willing and able to substitute pre-study prescribed inhaled asthma medication for the
             entire duration of the study with study medication.

         13. Written informed consent obtained as per national laws.

             Inclusion Criteria required following run-in:

         14. FEV1 within ≤20% of the visit 1 value following appropriate withholding of rescue
             medication (no salbutamol Airomir Autohaler use within 6 hours of the PFT).

        Rescue medication use on ≤2 days during the last 7 days of the run in period. Exclusion
        Criteria

        Subjects to be excluded from the study are those who meet any of the following criteria:

          1. Require medications other than inhaled SABAs and/or regular non-ICS controller
             medications (e.g., cromones or leukotriene receptor antagonists) to maintain asthma
             control.

          2. ICS use within ≤ 2 weeks prior to the screening visit.

          3. Any asthma exacerbation of any severity for at least 3 months prior to the screening
             visit.

          4. Any fracture in the leg to be measured by knemometry ≤6 months prior to the screening
             visit.

          5. Any metabolic disorders or other diseases that may impact on normal growth patterns.

          6. Near fatal or life-threatening asthma within the past year.

          7. Hospitalisation or an emergency visit for asthma within the past 6 months.

          8. History of oral or injectable corticosteroid medication ≤3 months prior to the
             screening visit.

          9. Evidence of a clinically unstable disease, as determined by medical history, clinical
             laboratory tests, and physical examination that, in the Investigator's opinion,
             preclude entry into the study. "Clinically significant" is defined as any disease
             that, in the opinion of the Investigator, would put the subject at risk through study
             participation, or which would affect the outcome of the study.

         10. No major surgery requiring general anesthesia for at least 3 months prior to the
             screening visit.

         11. No febrile illnesses with temperature > 39°C within a week of the screening visit.

         12. In the Investigator's opinion a clinically significant upper or lower respiratory
             infection within 4 weeks prior to the screening visit.

         13. Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis,
             bronchiectasis, tuberculosis).

         14. Subjects who have taken β- blocking agents, tricyclic antidepressants, monoamine
             oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrythmics, or potent
             CYP 3A4 inhibitors such as ketoconazole within 1 week prior to the screening visit.

         15. Current use of medications, other than those allowed in the protocol.

         16. Current evidence of hypersensitivity or idiosyncratic reaction to test medications or
             components.

         17. Receipt of an Investigational medicinal product within 30 days of the screening visit.