CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 134 enrolled
Drug / intervention
Dose 1, AZD8871 50 μg (Part 1) +10 moredrug
Likely dose
Dose 1, AZD8871 50 μg (Part 1)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02573155
NCT02573155Phase 1Completed
CompareCT.gov

A 2-part, Randomised, Placebo-controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of AZD8871 Delivered by Inhalation in Asthmatic and Chronic Obstructive Pulmonary Disease (COPD) Subjects

AstraZeneca·interventional·Posted Oct 9, 2015·Updated Nov 8, 2018

In Brief

A Phase 1 clinical trial evaluating Dose 1, AZD8871 50 μg (Part 1), Dose 2, AZD8871 100 μg (Part 1), and 9 other interventions for Asthma (Part 1) and COPD (Part 2). Completed, enrolled 134 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma (Part 1), COPD (Part 2)
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 9, 2015
Enrollment StartOct 1, 2015
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.7 years ago

Interventions

Dose 1, AZD8871 50 μg (Part 1)drug

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

Dose 2, AZD8871 100 μg (Part 1)drug

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

Dose 3, AZD8871 300 μg (Part 1)drug

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

Dose 4, AZD8871 600 µg (Part 1)drug

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

Dose 5, AZD8871 1200 µg (Part 1)drug

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

Dose 6, AZD8871 1800 μg (Part 1)drug

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

Placebo, AZD8871 placebo (Part 1)drug

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

Treatment A, AZD8871 dose A (Part 2)drug

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

Treatment B, AZD8871 dose B (Part 2)drug

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

Treatment C, Indacaterol 150 μg (Part 2)drug

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

Treatment D, Tiotropium 18 μg (Part 2)drug

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