Trial Outcomes & Findings for A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT01708057)

Results Overview

The maximum value over 24 hours post-dose, as change from baseline

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

The first 24 hours following dose administration

Results posted on

2014-01-15

Participant Flow

A total of 14 subjects were enrolled. Of these, 3 subjects were randomized to receive a treatment sequence consisting of 6 different treatments in random order. The study was terminated prematurely, hence only one period out of six planned was performed.

Participant milestones

Participant milestones
Measure	AFBECD AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug	FEADBC Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug	DCEBFA AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug
Overall Study STARTED	1	1	1
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AFBECD AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug	FEADBC Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug	DCEBFA AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug
Overall Study Withdrawal due to study termination.	1	1	1

Baseline Characteristics

A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Baseline n=3 Participants All Patients population
Age, Customized <=18 year	0 participants n=93 Participants
Age, Customized Between 18 and 65 years	2 participants n=93 Participants
Age, Customized >=65 years	1 participants n=93 Participants
Sex/Gender, Customized Male	2 participants n=93 Participants
Sex/Gender, Customized Female	1 participants n=93 Participants
Race/Ethnicity, Customized White	3 Participants n=93 Participants
Race/Ethnicity, Customized other	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: The first 24 hours following dose administration

Population: As the study was terminated prematurely none of the randomised patients have been analysed.

The maximum value over 24 hours post-dose, as change from baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 22 to 26 hours following dose administration

Population: As the study was terminated prematurely none of the randomized patients have been analysed.

The average over 22 to 26 hours, as change from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The first 24 hours following dose administration

Population: As the study was terminated prematurely none of the randomized patients have been analysed.

Average FEV1 (0-24h): The average over 0 to 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 24hr post dose

Population: As the study was terminated prematurely none of the randomised patients have bean analysed.

Maximum (post-dose values - baseline value) for each treatment visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The first 24 hours following dose administration

Population: As the study was terminated prematurely none of the randomised patients have bean analysed.

Maximum (post-dose values - baseline value) for each treatment visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 24hr post dose

Population: As the study was terminated prematurely none of the randomised patients have bean analysed.

Maximum (post-dose values - baseline value) for each treatment visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 24hr post dose

Population: As the study was terminated prematurely none of the randomised patients have bean analysed.

maximum (post-dose values - baseline value) for each treatment visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 24hr post-dose

Population: As the study was terminated prematurely none of the randomised patients have bean analysed.

Cmax, tmax, AUC