NCT02573155 - Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects | Biotech Hunter

Enrollment

134

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions

Asthma (Part 1)COPD (Part 2)

Interventions

DRUG

Dose 1, AZD8871 50 μg (Part 1)

50 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 2, AZD8871 100 μg (Part 1)

100 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 3, AZD8871 300 μg (Part 1)

300 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 4, AZD8871 600 µg (Part 1)

600 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 5, AZD8871 1200 µg (Part 1)

1200 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 6, AZD8871 1800 μg (Part 1)

1800 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Placebo, AZD8871 placebo (Part 1)

AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Treatment A, AZD8871 dose A (Part 2)

AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Treatment B, AZD8871 dose B (Part 2)

AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®)

DRUG

Treatment C, Indacaterol 150 μg (Part 2)

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

DRUG

Treatment D, Tiotropium 18 μg (Part 2)

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

Trial Locations (2)

Unknown

Research Site, Harrow

Research Site, Manchester