Clinical trial NCT02573155
Conditions: Asthma (Part 1) COPD (Part 2)
Keywords: Pharmacokinetics Pharmacodynamics AZD8871 Safety Tolerability mild persistent asthma moderate to severe COPD
Sponsor: AstraZeneca
Start date: 2015-10-01; Completion date: 2016-08-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Arms: arm 1: Period 1: Dose 1 Period 2: Dose 3 Period 3: Dose 5 arm 2: Period 1: Placebo Period 2: Dose 3 Period 3: Dose 5 arm 3: Period 1: Dose 1 Period 2: Placebo Period 3: Dose 5 arm 4: Period 1: Dose 1 Period 2: Dose 3 Period 3: Placebo arm 5: Period 1: Dose 2 Period 2: Dose 4 Period 3: Dose 6 arm 6: Period 1: Placebo Period 2: Dose 4 Period 3: Dose 6 arm 7: Period 1: Dose 2 Period 2: Placebo Period 3: Dose 6 arm 8: Period 1: Dose 2 Period 2: Dose 4 Period 3: Placebo arm 9: Period 1: Treatment A Period 2: Treatment B Period 3: Treatment E Period 4: Treatment C Period 5: Treatment D arm 10: Period 1: Treatment B Period 2: Treatment C Period 3: Treatment A Period 4: Treatment D Period 5: Treatment E arm 11: Period 1: Treatment C Period 2: Treatment D Period 3: Treatment B Period 4: Treatment E Period 5: Treatment A arm 12: Period 1: Treatment D Period 2: Treatment E Period 3: Treatment C Period 4: Treatment A Period 5: Treatment B arm 13: Period 1: Treatment E Period 2: Treatment A Period 3: Treatment D Period 4: Treatment B Period 5: Treatment C arm 14: Period 1: Treatment D Period 2: Treatment C Period 3: Treatment E Period 4: Treatment B Period 5: Treatment A arm 15: Period 1: Treatment E Period 2: Treatment D Period 3: Treatment A Period 4: Treatment C Period 5: Treatment B arm 16: Period 1: Treatment A Period 2: Treatment E Period 3: Treatment B Period 4: Treatment D Period 5: Treatment C arm 17: Period 1: Treatment B Period 2: Treatment A Period 3: Treatment C Period 4: Treatment E Period 5: Treatment D arm 18: Period 1: Treatment C Period 2: Treatment B Period 3: Treatment D Period 4: Treatment A Period 5: Treatment E
Interventions: intervention 1: Dose 1, AZD8871 50 μg (Part 1) intervention 2: Dose 2, AZD8871 100 μg (Part 1) intervention 3: Dose 3, AZD8871 300 μg (Part 1) intervention 4: Dose 4, AZD8871 600 µg (Part 1) intervention 5: Dose 5, AZD8871 1200 µg (Part 1) intervention 6: Dose 6, AZD8871 1800 μg (Part 1) intervention 7: Placebo, AZD8871 placebo (Part 1) intervention 8: Treatment A, AZD8871 dose A (Part 2) intervention 9: Treatment B, AZD8871 dose B (Part 2) intervention 10: Treatment C, Indacaterol 150 μg (Part 2) intervention 11: Treatment D, Tiotropium 18 μg (Part 2)
Intervention descriptions: intervention 1: 50 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) intervention 2: 100 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) intervention 3: 300 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) intervention 4: 600 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) intervention 5: 1200 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) intervention 6: 1800 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) intervention 7: AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) intervention 8: AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) intervention 9: AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) intervention 10: 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 intervention 11: 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

Protocol documents: