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Study in Subjects with Asthma to Compare the Bronchodilatoric Effects of Salmeterol (at two different doses) and Fluticasone Propionate when Taken Via a Novel Inhaler Device (PulmoJet®) Compared to th...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-005047-40

Study in Subjects with Asthma to Compare the Bronchodilatoric Effects of Salmeterol (at two different doses) and Fluticasone Propionate when Taken Via a Novel Inhaler Device (PulmoJet®) Compared to the Seretide Diskus® Inhaler

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Extrait

The primary objective is to demonstrate the therapeutic non-inferiority of the bronchodilator responses (area under the time curve of forced expiratory volume in 1 second [AUC-FEV1]) over 12 hours of the salmeterol component (50 µg) of a novel SAL/FP combination dry powder inhaler product (PulmoJet 50 µg/250 µg SAL/FP; test) with the respective mid-strength of the European reference product (Seretide Diskus; reference).

Critère d'inclusion

  • Mild to moderate asthma

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