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Clinical assessment of fluticasone propionate/ salmeterol xinafoate HFA MDI in 6-month to 4-year-old Japanese patients with bronchial asthma

Update Il y a 4 ans
Reference: EUCTR2016-003479-22

Woman and Man

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Extract

To evaluate the efficacy and safety of fluticasone propionate (FP)/ salmeterol xinafoate (SLM) HFA MDI 50/25 µg 1 or 2 inhalation twice daily for 8 weeks in comparison with FP HFA MDI 50 µg 1 or 2 inhalation twice daily in 6-month to 4-year-old Japanese patients with infantile bronchial asthma. In addition, the safety of long-term treatment of FP/ SLM HFA MDI 50/25 µg 1 or 2 inhalation twice daily will be evaluated in the 16 weeks of extension period.

Inclusion criteria

  • Bronchial asthma