Adults 18 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1).Primary· 45 mins and 15 mins pre-dose, and 23.00-24.00 h post-dose on Day 1
Baseline for FEV1 was defined as the mean of the two measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min), prior to the morning investigational product (IP) administration on Day 1 of each treatment period. If both were missing the screening value was used instead.
Trough is defined as the mean of the FEV1 values obtained at 23 h and 24 h after the morning IP administration. If one of the values was missing, the other one was used as trough.
Percentage of Participants Achieving a ≥ 200 mL and ≥12% Increase From Baseline in Peak FEV1 on Day 1.Secondary· Predose and 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h and 6 h post-dose on Day 1
The percentage of patients achieving at least 200 mL and 12% increase from baseline in peak FEV1 on Day 1 of each treatment. The peak was the highest value observed during the 6 hour-period immediately after the IP dose in the morning on Day 1.
Time to Peak FEV1 at Day 1Secondary· 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h and 6 h post-dose on Day 1
The peak is the highest forced expiratory volume in one second (FEV1) value observed during the 6 hour-period immediately after the IP dose in the morning on Day 1.
Observed Maximum Concentration of Abediterol (Cmax)Secondary· Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.
Observed maximum concentration (Cmax) of Abediterol, taken directly from the individual concentration-time curve.
Time (h) to Maximum Concentration of Abediterol (Tmax).Secondary· Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.
Time to maximum concentration (Tmax) of Abediterol (h), taken directly from the individual concentration-time curve.
Terminal Rate Constant of Abediterol (λz)Secondary· Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.
Terminal rate constant (λz) of Abediterol, estimated by log-linear least square regression of the terminal part of the concentration-time curve.
Group
Value
95% CI
Abediterol Dry Powder Inhaler 2.5 μg
0.0526
± 0.0228
Abediterol Pressurised Metered-dose Inhaler 2.5μg
0.0640
± 0.0201
Terminal Half-life (h) of Abediterol (t½λz)Secondary· Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.
Terminal half-life (h), estimated as (ln2)/λz (t1/2λz).
Group
Value
95% CI
Abediterol Dry Powder Inhaler 2.5 μg
14.99
± 4.827
Abediterol Pressurised Metered-dose Inhaler 2.5μg
11.85
± 3.533
AUClast of AbediterolSecondary· Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.
Area under the plasma concentration-curve of Abediterol from time zero to the time of last quantifiable analyte concentration.
Group
Value
95% CI
Abediterol Dry Powder Inhaler 2.5 μg
9.092
± 53.95
Abediterol Pressurised Metered-dose Inhaler 2.5μg
7.674
± 132.5
AUC of Abediterol.Secondary· Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.
Area under the Abediterol concentration-time curve from time zero extrapolated to infinity (AUC). AUC is estimated by AUClast + Clast/λz where Clast is the last observed quantifiable concentration (AUC).
PK blood samples were collected 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1 (Note that 24 h and 36 h time-points post-dose correspond to Day 2).
Group
Value
95% CI
Abediterol Dry Powder Inhaler 2.5 μg
12.73
± 43.26
Abediterol Pressurised Metered-dose Inhaler 2.5μg
11.08
± 50.01
Apparent Plasma Clearance for Abediterol (CL/F).Secondary· Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.
Apparent plasma clearance for parent drug estimated as dose divided by AUC (CL/F).
Group
Value
95% CI
Abediterol Dry Powder Inhaler 2.5 μg
196.4
± 43.26
Abediterol Pressurised Metered-dose Inhaler 2.5μg
225.6
± 50.01
Apparent Volume of Distribution for Abediterol at Terminal Phase (Vz/F).Secondary· Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.
Apparent volume of distribution for parent drug at terminal phase, estimated by dividing the apparent clearance (CL/F) by λz (Vz/F).
Group
Value
95% CI
Abediterol Dry Powder Inhaler 2.5 μg
4008
± 37.41
Abediterol Pressurised Metered-dose Inhaler 2.5μg
3690
± 49.93
Mean Residence Time (MRT) of Abediterol.Secondary· Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.
Mean residence time (h), calculated by AUMC/AUC, where AUMC is the area under the first moment-time curve (MRT).
Group
Value
95% CI
Abediterol Dry Powder Inhaler 2.5 μg
19.73
± 35.48
Abediterol Pressurised Metered-dose Inhaler 2.5μg
15.59
± 29.57
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of informed consent, throughout the treatment period and including the follow-up period (ie, 2 weeks after last IP dose). Treatment-emergent adverse events were those reported after the first dose of IP up to 30 days after last IP dose..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to investigate the pharmacodynamics of single doses of abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is a potential for once daily treatment of asthma and chronic obstructive pulmonary disease (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel anti-inflammatory agent. The aim of the clinical studies is to enable further investigations in participants with asthma and COPD to evaluate and develop abediterol as an effective long acting bronchodilator with an acceptable safety profile compared to other inhaled bronchodilators on the market, for the treatment of asthma and COPD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 24 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02777827.