AsthmaPhase 1NCT03273127

To Assess the Pharmacokinetics, Safety and Tolerability of Abediterol Administered Once Daily for 9 Days, in Patients With Asthma on Inhaled Corticosteroids

A Phase 1 study testing Abediterol in people with Asthma, run by AstraZeneca at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A Phase 1 study to assess pharmacokinetics (PK) and safety of abediterol 5 μg dry powder inhaler (DPI) given once daily (QD) for 9 days, compared to placebo, in patients with asthma on inhaled corticosteroids (ICSs). Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Asthma
What is being tested?: Abediterol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteGermany
Study dates: 21 Sep 2017to 9 Nov 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Male and non-pregnant, non-lactating female patients aged 18 - 55 years with asthma and with suitable veins for cannulation or repeated venipuncture.
Non-smoker or former smoker who quit ≥ 6 months prior to Visit 1 and have a total smoking history of ≤ 10 pack-years. Note: Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has been smoking. For example, a person who smokes 40 cigarettes a day and has been smoking for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 × 10 years of smoking = 20 pack-year history).
Patient with documented clinical diagnosis of asthma for ≥ 6 months before Visit 1 according to Global Initiative for Asthma (GINA) guidelines.
Patient with blood pressure (defined as systolic blood pressure [SBP] ≥ 90 and ≤ 140 mmHg, and diastolic blood pressure [DBP] ≥ 50 and ≤ 90 mmHg) at Screening, measured after resting in the supine position for 5 minutes.
Patient with no relevant clinical laboratory findings at Screening (Visits 1 or 2) as judged by the Investigator.

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Patient on stable dose of ICSs for at least 1 month prior to Visit 1. Patients on bronchodilators will need to do appropriate wash-out prior to the pulmonary function test at Visit 2.
Patient with pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Visit 2 ≥ 40% and ≤ 90% of predicted (mean of 2 pre-bronchodilator measurements taken 30 minutes apart).
Patient who demonstrates the ability to use the study inhalation device properly.
Patient able to perform acceptable pulmonary function testing for FEV1 according to American Thoracic Society (ATS)/European Respiratory Society (ERS) acceptability criteria.
Negative pregnancy test (serum pregnancy test at Screening) for female patients.
Female patients must be post-menopausal, surgically sterile, or must be able to adhere to the conditions of contraceptive requirements. Male patients must be surgically sterile or must be able to adhere to the conditions of contraceptive requirements.
Patients willing not to donate blood during the study and for 3 months following their last dose of IMP.
Patient willing and able to follow study directions and restrictions.
Patient must be able to read, speak and understand German language.

Who cannot join

Patient has known or suspected hypersensitivity to the IMP or excipients, including lactose (Note: lactose intolerance is not an exclusion criterion).
Patient who has used systemic steroid in the 6 weeks before Visit 1.
Patient with a history of hospitalization due to asthma in the 6 months prior to Visit 1 or a history of intubation because of asthma at any time in their lifetime.
Patient with any active pulmonary disease other than asthma.
Patient non-compliant with study procedures in the Screening period (prior to randomization) -as judged by the Investigator.
Patient under treatment with biologicals such as monoclonal antibodies or chimeric biomolecules including omalizumab, mepolizumab, and reslizumab within 6 months or 5 half-lives before Visit 1, whichever is longer.

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Patient treated with any investigational drug within 30 days (or 5 half-lives, whichever is longer) prior to Visit 1.
Patient on treatment with strong cytochrome P450 (CYP)3A4 inhibitors such as ketoconazole or itraconazole or CYP3A4 inducers such as rifampin at Visit 1 or within 14 days prior to administration of IMP.
Patient with a history, laboratory abnormality, or clinical suspicion of any clinically relevant disease or disorder, including uncontrolled hypertension or uncontrolled diabetes, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study, or any other safety concerns in the opinion of the Investigator.
Patient with diagnosis of any kind of chronic hepatitis or known human immunodeficiency virus (HIV) infections at the time of enrolment.
Patient with any active malignancy or treatment thereof within the five years prior to enrolment.
Patient with any clinically important abnormalities in rhythm, conduction, or morphology of the screening 12-lead ECG as judged by the Investigator on the screening ECG.
Patient with prolonged QT interval using Fridericia's correction ≥ 450 msec for males and females on the screening ECG or family history of long QT syndrome.
Patient with PR (PQ) interval prolongation (> 240 msec), intermittent second or third degree atrio-ventricular (AV) block or AV dissociation or with QRS interval ≥ 120 msec or any other ECG abnormality which might affect the evaluation of the central ECG reading on the screening ECG.
Patient with heart rate (HR) < 45 beat per minute (bpm) or > 90 bpm at Screening ECG.
Patient with implanted cardiac defibrillator and patients with sustained symptomatic ventricular and/or atrial tachyarrhythmia.
Patient with any contraindication against the use of sympathomimetic drugs as judged by the Investigator.
Patient with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society Class II, or a myocardial infarction, or stroke within 6 months before Visit 1.
Patient with a history of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) Class II.
Patient who failed the screening procedures or patient with previous participation in the current study. Patients who failed the screening procedures may be re-screened once only.
Patient with a history of or current alcohol or drug abuse (including marijuana), as judged by the Investigator.
Patient with planned in-patient surgery, major dental procedure or hospitalization during the study.
Patient involved in the planning and/or conduct of the study (applies to both AstraZeneca staff, contract research organization (CRO) staff and/or staff at the study site).
Vulnerable person (e.g., person kept in detention).
Patient with exacerbation requiring emergency room visit or systemic steroid use or increased dose of ICS within the Screening Period
Patient who intends to use any concomitant medication not permitted by this protocol.
Patient who received live attenuated vaccine within 30 days prior to Visit 1 or who received inactivated vaccine within 7 days prior to Visit 1.
Donation or loss of > 400 mL blood and plasma within the previous 3 months prior to Screening.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Berlin, 14050

Other trials in Germany

About this study

Official title: A Phase 1, Randomized, Single-Blind, Placebo Controlled Study to Assess Pharmacokinetics, Safety and Tolerability of Abediterol Administered Once Daily for 9 Days, in Patients With Asthma on Inhaled Corticosteroids

Read the detailed description

This is a randomized, single-blind, placebo-controlled study to assess PK and safety of abediterol 5 μg DPI given QD for 9 days, compared to placebo, in patients with asthma on ICSs. It is planned that 12 patients with asthma will be randomized into the study, of which 9 will receive abediterol 5 μg and 3 will receive placebo. The entire study period is scheduled to take a maximum of 41 days (follow-up included) for each individual patient. During the screening period, all patients will take their own baseline inhaled corticosteroids. Patients on long-acting β2-agonist/inhaled corticosteroids will be switched over to the respective inhaled corticosteroid mono-component at Visit 1. Patients will be provided salbutamol as rescue medication for use throughout the study. Each patient will receive a single inhaled dose of abediterol or placebo in the morning of Days 1 to 9 (Visits 3 to 8) under supervision of the Investigator or designee.

Conditions: Asthma
Being tested: Abediterol, Placebo
Keywords: Asthma, placebo, abediterol, DPI, corticosteroids
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AbediterolDrug
A β2-adrenoceptor agonists, produce smooth muscle relaxation in the airways and improves lung function.
PlaceboDrug
Abediterol matching placebo without any pharmacological activity.

Study groups in NCT03273127
Study group	Role	What they receive
Abediterol 5 μg	Experimental	Out of 12 randomized patients, 9 will receive abediterol 5 μg as dry inhalation powder orally once daily for 9 days. Patients will be provided salbutamol as rescue medication for use throughout the study. During the treatment period, all patients will be continued on their current ICSs. In addition, each patient will receive Abediterol 5.0 μg QD. Receives: Drug: Abediterol
Placebo	Placebo comparator	Out of 12 randomized patients, 3 will receive placebo as dry inhalation powder orally once daily for 9 days. Patients will be provided salbutamol as rescue medication for use throughout the study. During the treatment period, all patients will be continued on their current ICSs. In addition, each patient will receive placebo QD. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Observed maximum plasma concentration (Cmax) assessment for abediterol on Day 1
To assess Cmax after single inhaled dose of abediterol 5 μg. Cmax will be taken directly from the individual concentration-time curve.
Measured: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours
Time to reach maximum plasma concentration (tmax) assessment for abediterol on Day 1
To assess tmax after single inhaled dose of abediterol 5 μg. tmax will be taken directly from the individual concentration-time curve.
Measured: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours
Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 1
To assess AUClast after single inhaled dose of abediterol 5 μg.
Measured: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours
Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 1
To assess AUC(0-24) after single inhaled dose of abediterol 5 μg.
Measured: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours
Observed maximum concentration (Cmax) assessment for abediterol on Day 9
To assess Cmax after multiple once daily inhaled doses of abediterol 5 μg. Cmax will be taken directly from the individual concentration-time curve.
Measured: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Time to reach maximum concentration (tmax) assessment for abediterol on Day 9
To assess tmax after multiple once daily inhaled doses of abediterol 5 μg. tmax will be taken directly from the individual concentration-time curve.
Measured: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Terminal rate constant, estimated by log-linear LS regression of the terminal part of the concentration-time curve (λz) assessment for abediterol on Day 9
To assess λz after multiple once daily inhaled doses of abediterol 5 μg.
Measured: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Terminal half-life, estimated as (ln2)/λz (t½λz) assessment for abediterol on Day 9
To assess t½λz after multiple once daily inhaled doses of abediterol 5 μg.
Measured: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 9
To assess AUClast after multiple once daily inhaled doses of abediterol 5 μg.
Measured: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 9
To assess AUC(0-24) after multiple once daily inhaled doses of abediterol 5 μg.
Measured: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Apparent clearance for drug estimated as dose divided by AUC0-24 (CL/F) assessment for abediterol on Day 9
To assess CL/F after multiple once daily inhaled doses of abediterol 5 μg.
Measured: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Average plasma concentration during a dosing interval, estimated as AUC0-24/24 (Cavg) assessment for abediterol on Day 9
To assess Cavg after multiple once daily inhaled doses of abediterol 5 μg.
Measured: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Fluctuation index during a dosing interval estimated as 100*(Cmax - Cmin)/Cavg (%), where Cmin is the minimum concentration at the end of the dosing interval (%Fluctuation) assessment for abediterol on Day 9
To assess %Fluctuation after multiple once daily inhaled doses of abediterol 5 μg.
Measured: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Accumulation ratio for Cmax estimated as (Cmax on Day 9/Cmax on Day 1) (Rac (Cmax)) assessment for abediterol on Day 9
To assess Rac (Cmax) after multiple once daily inhaled doses of abediterol 5 μg.
Measured: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours; Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Accumulation ratio for AUC0-24 estimated as (AUC0-24 on Day 9/AUC0-24 on Day 1) (Rac (AUC0-24)) assessment for abediterol on Day 9
To assess Rac (AUC0-24) after multiple once daily inhaled doses of abediterol 5 μg.
Measured: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours; Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
Vital sign (Blood pressure [BP])
Systolic and diastolic BP (in mmHg) will be measured after the patient has rested in the supine position for at least 5 minutes and before taking any blood sample and conducting any spirometry.
Measured: Change from baseline up to Day 13
Vital sign (pulse)
Pulse (beats per minute [bpm]) will be measured after the patient has rested in the supine position for at least 5 minutes and before taking any blood sample and conducting any spirometry.
Measured: Change from baseline up to Day 13
12-lead Electrocardiograms (ECGs) including high precision QTc analysis and telemetry
12-Lead ECG results performed for safety evaluation will be listed for each patient and will include the ECG parameters (where applicable [Screening, pre-dose Day 1 and Follow-up]) and changes from baseline, assessment by the Investigator (normal/abnormal not clinically significant/abnormal clinically significant) and details of any abnormalities (rhythm, ectopy, conduction, morphology, myocardial infarction, ST segment, T wave and U wave observations).
Measured: Change from baseline up to Day 13
Clinical laboratory assessments (hematology, clinical chemistry and urinalysis)
Hematology and clinical chemistry values (including serial potassium and glucose) will be listed by patient and time point including changes from baseline (pre-dose Day 1) and repeat/unscheduled measurements. Urinalysis will include glucose, protein, blood, leucocytes, flow cytometry, microscopy.
Measured: Change from baseline up to Day 11
Number of patients with Adverse Events (AEs)
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, electrocardiogram). In clinical studies an AE can include an undesirable medical condition occurring at any time after the patient has signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Measured: Change from baseline up to follow-up (14 ± 2 days post (final) dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 20179 Nov 2017

First posted6 Sep 2017
Study start21 Sep 2017
Primary completion9 Nov 2017
Study completion9 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03273127
Sponsor's protocol ID: D6540C00006
Status last verified: Nov 2017
First submitted: 4 Sep 2017
Last updated: 27 Nov 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Single-Blind, Placebo Controlled Study to Assess Pharmacokinetics, Safety and Tolerability of Abediterol Administered Once Daily for 9 Days, in Patients With Asthma on Inhaled Corticosteroids
ClinicalTrials.gov ID: NCT03273127
Acronym / sponsor ID: D6540C00006
Conditions: Asthma
Keywords: Asthma, placebo, abediterol, DPI, corticosteroids
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 21 Sep 2017 (actual)
Primary completion: 9 Nov 2017 (actual)
Study completion: 9 Nov 2017 (actual)
First posted: 6 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Abediterol 5 μg	Experimental	Drug: AbediterolOut of 12 randomized patients, 9 will receive abediterol 5 μg as dry inhalation powder orally once daily for 9 days. Patients will be provided salbutamol as rescue medication for use throughout the study. During the treatment period, all patients will be continued on their current ICSs. In addition, each patient will receive Abediterol 5.0 μg QD.
Placebo	Placebo comparator	Drug: PlaceboOut of 12 randomized patients, 3 will receive placebo as dry inhalation powder orally once daily for 9 days. Patients will be provided salbutamol as rescue medication for use throughout the study. During the treatment period, all patients will be continued on their current ICSs. In addition, each patient will receive placebo QD.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (15 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Male and non-pregnant, non-lactating female patients aged 18 - 55 years with asthma and with suitable veins for cannulation or repeated venipuncture.
Non-smoker or former smoker who quit ≥ 6 months prior to Visit 1 and have a total smoking history of ≤ 10 pack-years. Note: Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has been smoking. For example, a person who smokes 40 cigarettes a day and has been smoking for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 × 10 years of smoking = 20 pack-year history).
Patient with documented clinical diagnosis of asthma for ≥ 6 months before Visit 1 according to Global Initiative for Asthma (GINA) guidelines.
Patient with blood pressure (defined as systolic blood pressure [SBP] ≥ 90 and ≤ 140 mmHg, and diastolic blood pressure [DBP] ≥ 50 and ≤ 90 mmHg) at Screening, measured after resting in the supine position for 5 minutes.

Key exclusion criteria (28 listed)

Patient has known or suspected hypersensitivity to the IMP or excipients, including lactose (Note: lactose intolerance is not an exclusion criterion).
Patient who has used systemic steroid in the 6 weeks before Visit 1.
Patient with a history of hospitalization due to asthma in the 6 months prior to Visit 1 or a history of intubation because of asthma at any time in their lifetime.
Patient with any active pulmonary disease other than asthma.
Patient non-compliant with study procedures in the Screening period (prior to randomization) -as judged by the Investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AbediterolA β2-adrenoceptor agonists, produce smooth muscle relaxation in the airways and improves lung function.	Drug	Abediterol 5 μg
PlaceboAbediterol matching placebo without any pharmacological activity.	Drug	Placebo

Primary outcome

Observed maximum plasma concentration (Cmax) assessment for abediterol on Day 1
Time frame: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours
To assess Cmax after single inhaled dose of abediterol 5 μg. Cmax will be taken directly from the individual concentration-time curve.
Time to reach maximum plasma concentration (tmax) assessment for abediterol on Day 1
Time frame: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours
To assess tmax after single inhaled dose of abediterol 5 μg. tmax will be taken directly from the individual concentration-time curve.
Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 1
Time frame: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours
To assess AUClast after single inhaled dose of abediterol 5 μg.
Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 1
Time frame: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours
To assess AUC(0-24) after single inhaled dose of abediterol 5 μg.
Observed maximum concentration (Cmax) assessment for abediterol on Day 9
Time frame: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess Cmax after multiple once daily inhaled doses of abediterol 5 μg. Cmax will be taken directly from the individual concentration-time curve.
Time to reach maximum concentration (tmax) assessment for abediterol on Day 9
Time frame: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess tmax after multiple once daily inhaled doses of abediterol 5 μg. tmax will be taken directly from the individual concentration-time curve.
Terminal rate constant, estimated by log-linear LS regression of the terminal part of the concentration-time curve (λz) assessment for abediterol on Day 9
Time frame: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess λz after multiple once daily inhaled doses of abediterol 5 μg.
Terminal half-life, estimated as (ln2)/λz (t½λz) assessment for abediterol on Day 9
Time frame: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess t½λz after multiple once daily inhaled doses of abediterol 5 μg.
Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 9
Time frame: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess AUClast after multiple once daily inhaled doses of abediterol 5 μg.
Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 9
Time frame: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess AUC(0-24) after multiple once daily inhaled doses of abediterol 5 μg.
Apparent clearance for drug estimated as dose divided by AUC0-24 (CL/F) assessment for abediterol on Day 9
Time frame: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess CL/F after multiple once daily inhaled doses of abediterol 5 μg.
Average plasma concentration during a dosing interval, estimated as AUC0-24/24 (Cavg) assessment for abediterol on Day 9
Time frame: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess Cavg after multiple once daily inhaled doses of abediterol 5 μg.
Fluctuation index during a dosing interval estimated as 100*(Cmax - Cmin)/Cavg (%), where Cmin is the minimum concentration at the end of the dosing interval (%Fluctuation) assessment for abediterol on Day 9
Time frame: Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess %Fluctuation after multiple once daily inhaled doses of abediterol 5 μg.
Accumulation ratio for Cmax estimated as (Cmax on Day 9/Cmax on Day 1) (Rac (Cmax)) assessment for abediterol on Day 9
Time frame: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours; Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess Rac (Cmax) after multiple once daily inhaled doses of abediterol 5 μg.
Accumulation ratio for AUC0-24 estimated as (AUC0-24 on Day 9/AUC0-24 on Day 1) (Rac (AUC0-24)) assessment for abediterol on Day 9
Time frame: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours; Day 9: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours
To assess Rac (AUC0-24) after multiple once daily inhaled doses of abediterol 5 μg.
Vital sign (Blood pressure [BP])
Time frame: Change from baseline up to Day 13
Systolic and diastolic BP (in mmHg) will be measured after the patient has rested in the supine position for at least 5 minutes and before taking any blood sample and conducting any spirometry.
Vital sign (pulse)
Time frame: Change from baseline up to Day 13
Pulse (beats per minute [bpm]) will be measured after the patient has rested in the supine position for at least 5 minutes and before taking any blood sample and conducting any spirometry.
12-lead Electrocardiograms (ECGs) including high precision QTc analysis and telemetry
Time frame: Change from baseline up to Day 13
12-Lead ECG results performed for safety evaluation will be listed for each patient and will include the ECG parameters (where applicable [Screening, pre-dose Day 1 and Follow-up]) and changes from baseline, assessment by the Investigator (normal/abnormal not clinically significant/abnormal clinically significant) and details of any abnormalities (rhythm, ectopy, conduction, morphology, myocardial infarction, ST segment, T wave and U wave observations).
Clinical laboratory assessments (hematology, clinical chemistry and urinalysis)
Time frame: Change from baseline up to Day 11
Hematology and clinical chemistry values (including serial potassium and glucose) will be listed by patient and time point including changes from baseline (pre-dose Day 1) and repeat/unscheduled measurements. Urinalysis will include glucose, protein, blood, leucocytes, flow cytometry, microscopy.
Number of patients with Adverse Events (AEs)
Time frame: Change from baseline up to follow-up (14 ± 2 days post (final) dose)
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, electrocardiogram). In clinical studies an AE can include an undesirable medical condition occurring at any time after the patient has signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr.med. Rainard Fuhr principal investigator

PAREXEL Early Phase Clinical Unit Berlin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abediterol in people with Asthma, run by AstraZeneca at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observed maximum plasma concentration (Cmax) assessment for abediterol on Day 1 (time frame: Day 1: pre-dose and post-dose at 5, 15, 30, 45 minutes and 1, 2, 3, 4, 6, 8, 12 and 24 hours). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03273127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.