Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects
Condition: Asthma (Part 1); COPD (Part 2)
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomised, placebo-controlled 2-part study to assess the safety,
      tolerability, pharmacokinetics and pharmacodynamics of AZD8871 delivered by inhalation, in
      asthmatic and chronic obstructive pulmonary disease (COPD) subjects.
    

Detailed description: 
      This study is an integrated Phase I protocol divided into 2 parts.

      Part 1: single ascending dose study (6 AZD8871 dose levels) in 16 male subjects with mild
      asthma. AZD8871 will be administered (by the Genuair® inhaler) under supervision at the study
      centre, according to the randomisation scheme

      Part 2: a 5 treatment period single dose study (of AZD8871 [two doses], indacaterol,
      tiotropium and placebo) in 40 male and non-childbearing female subjects with moderate to
      severe COPD. Each treatment period will be separated by a washout period of at least 7 days.
      The primary comparison for bronchodilation will be between AZD8871 doses and placebo.
    

Intervention name(s): Dose 1, AZD8871 50 μg (Part 1); Dose 2, AZD8871 100 μg (Part 1); Dose 3, AZD8871 300 μg (Part 1); Dose 4, AZD8871 600 µg (Part 1); Dose 5, AZD8871 1200 µg (Part 1); Dose 6, AZD8871 1800 μg (Part 1); Placebo, AZD8871 placebo (Part 1); Treatment A, AZD8871 dose A (Part 2); Treatment B, AZD8871 dose B (Part 2); Treatment C, Indacaterol 150 μg (Part 2); Treatment D, Tiotropium 18 μg (Part 2)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®); 100 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®); 300 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®); 600 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®); 1200 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®); 1800 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®); AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®); AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®); AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®); 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule; 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics; AZD8871; Safety; Tolerability; mild persistent asthma; moderate to severe COPD