Asthma (Part 1)Phase 1NCT02573155
Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects
A Phase 1 study testing Dose 1, AZD8871 50 μg (Part 1), Dose 2, AZD8871 100 μg (Part 1) and Dose 3, AZD8871 300 μg (Part 1) in people with Asthma (Part 1) and COPD (Part 2), run by AstraZeneca at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Asthma (Part 1), COPD (Part 2)
- What is being tested?
- Dose 1, AZD8871 50 μg (Part 1), Dose 2, AZD8871 100 μg (Part 1) and Dose 3, AZD8871 300 μg (Part 1)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2015to Aug 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are able and willing to provide written informed consent prior to conducting any study-related procedures, including withdrawal of medications
- Adult male subjects aged 18 to 70 years (both inclusive)
- Body mass index (BMI) from 18 to 32 kg/m2 at screening
- Clinical diagnosis of asthma (according to the Global Initiative for Asthma [GINA] guidelines) for at least 6 months prior to screening
- Ability to change current asthma therapy, to discontinue previous prescribed medications after signature of informed consent as per required washout periods
- Screening FEV1 value of ≥70% of the predicted normal value
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- FEV1 reversibility of ≥12% and an absolute increase of at least 200 mL over the baseline value within 30 min after inhalation of 400 µg (4 puffs) of salbutamol via a metered dose inhaler, with spacer device
- Subjects using intermittent salbutamol and / or subjects on a stable dose of low dose Inhaled corticosteroid (as defined by the GINA guidelines) at least 4 weeks prior to screening
- Predose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation
- No current smokers, no subjects with a smoking history during the last 12 months and no subjects with a total smoking history of more than 10 pack-years
- No other relevant pulmonary disease or history of thoracic surgery
- Subjects who are otherwise healthy as determined by medical history, physical examination, 12-lead ECG findings
- Normal blood pressure (defined as Systolic blood pressure [SBP] between 100 and 140 mmHg for subjects ≤59 years of age and between 100 and 150 mmHg for subjects ≥60 years of age, and Diastolic blood pressure [DBP] between 40 and 90 mmHg) at screening
- Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator.
- Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody (IgM), hepatitis C antibody and human immunodeficiency virus (HIV) I and II antibodies at screening
- Subjects who are negative for drugs of abuse and alcohol tests at screening and admission
- Subjects able to perform repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005(9) criteria at screening
- Adult male and non-childbearing female subjects aged ≥40 years with a clinical diagnosis of stable moderate to severe COPD according to GOLD guidelines at screening
- Females must be of non-childbearing potential, confirmed at screening by fulfilling study predefined criteria
- Post-salbutamol FEV1 <80% and ≥30% of the predicted normal value and post-salbutamol FEV1 / forced vital capacity (FVC) <70%
- BMI < 40 kg/m2 at screening
- Ability to change current COPD therapy, to discontinue previous prescribed medications after signature of informed consent as per required washout periods
- Current or ex-smokers with a smoking history of ≥10 pack years
- No evidence of clinically significant respiratory and / or cardiovascular conditions (e.g. uncontrolled hypertension) or laboratory abnormalities
- No other relevant pulmonary disease or history of thoracic surgery
- Subjects who are negative for HBsAg, HBc IgM, hepatitis C antibody and HIV I and II antibodies at screening
- Subjects who are able and willing to provide written informed consent prior to conducting any study-related procedures, including withdrawal of medications
- Medical history must be verified by either a personal physician or medical practitioner as appropriate
- Subjects able to perform repeatable pulmonary function testing for FEV1 according to the ATS / ERS 2005(9) criteria at screening
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrolment or randomisation of treatment in the present study
- Current evidence or recent history of any clinically significant and unstable disease (other than asthma/COPD) or abnormality that could put the subject at risk or could confound the results of the study
- Subjects with a surgical history clinically relevant for the purpose of the study
- History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin
- Subjects with serious adverse reaction or serious hypersensitivity to Tiotropium (for Part 2 only), Indacaterol (for Part 2 only), or the formulation excipients (eg, lactose) or other drugs in the same pharmacologic class (for Part 1 and Part 2)
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- Current diagnosis of COPD (for Part 1 only) or history of / or current diagnosis for asthma (for Part 2 only)
- Recent history of asthma / COPD exacerbation requiring hospitalisation or need for increased maintenance treatments for asthma / COPD within 6 weeks prior to screening or prior to randomisation
- Use of daily oxygen therapy >10 h per day (for Part 2 only)
- Use of systemic steroids for respiratory reasons within 6 weeks prior to screening
- Lower respiratory tract infection within 6 weeks prior to screening or prior to randomisation
- Upper respiratory tract infection requiring antibiotics within 6 weeks prior to screening or prior to randomisation
- Current history of tuberculosis, bronchiectasis or other non-specific pulmonary disease
- Subject with significant cardiovascular disease that may be vulnerable to cardiovascular instability
- QTcF (QT interval corrected, Fridericia formula QT[msec]/RR[s]) interval, >450 ms for males and >470 ms for females at screening or prior to randomisation, or history of long QT syndrome
- PR (duration in milliseconds from the beginning of wave P to onset of ventricular depolarisation [Q or R]) interval >200 ms at screening or prior to randomisation (for Part 1 only) Note: 4- 6 hours of ECG rhythm monitoring with telemetry will be performed on Day-1 to identify patients that may have any clinical significant abnormality prior to randomisation. If this occurs, patients should not participate in the study
- Subjects with serum potassium concentration < 3.5mmol/l at screening
- Subjects with a history of excessive use or abuse of alcohol within the past 2 years
- Subjects with a history of drug abuse within the past 2 years
- Subjects who are positive for drugs of abuse and alcohol tests at screening and prior to randomisation. Subjects consuming more than 14 (female subjects) or 21 (male subjects) units of alcohol a week
- Donation or loss >400 ml of blood and plasma within the previous 3 months prior to screening
- Subjects with a significant infection or known inflammatory process at screening or prior to randomisation
- Subjects with acute gastrointestinal symptoms at the time of screening or prior to randomisation (eg, nausea, vomiting, diarrhoea, heartburn)
- Subjects with an acute infection such as influenza at the time of screening or prior to randomisation
- Male subjects who do not agree to follow instructions to avoid pregnancies
- Subjects who are not able to adhere to the restrictions on prior and concomitant medications
- Subjects who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication
- Subjects who have used any investigational drug within 3 months prior to screening or within the equivalent time of 6 half-lives of receiving the last administration, whichever is longer
- Subjects who have received the last dose of investigational product more than 3 months ago but who are on an extended follow-up
- Subjects who are unlikely to co-operate with the requirements of the study, or the study center or the subjects who are unwilling or unable to follow the instructions of the principal investigator
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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
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.
Read the detailed description
This study is an integrated Phase I protocol divided into 2 parts.
Part 1: single ascending dose study (6 AZD8871 dose levels) in 16 male subjects with mild asthma. AZD8871 will be administered (by the Genuair® inhaler) under supervision at the study centre, according to the randomisation scheme
Part 2: a 5 treatment period single dose study (of AZD8871 [two doses], indacaterol, tiotropium and placebo) in 40 male and non-childbearing female subjects with moderate to severe COPD. Each treatment period will be separated by a washout period of at least 7 days. The primary comparison for bronchodilation will be between AZD8871 doses and placebo.
- Conditions
- Asthma (Part 1), COPD (Part 2)
- Being tested
- Dose 1, AZD8871 50 μg (Part 1), Dose 2, AZD8871 100 μg (Part 1), Dose 3, AZD8871 300 μg (Part 1), Dose 4, AZD8871 600 µg (Part 1), Dose 5, AZD8871 1200 µg (Part 1)
- Keywords
- Pharmacokinetics, Pharmacodynamics, AZD8871, Safety, Tolerability, mild persistent asthma, moderate to severe COPD
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1, Part 1 | Experimental | Period 1: Dose 1 Period 2: Dose 3 Period 3: Dose 5 Receives: Drug: Dose 1, AZD8871 50 μg (Part 1); Drug: Dose 3, AZD8871 300 μg (Part 1); Drug: Dose 5, AZD8871 1200 µg (Part 1) |
| Sequence 2, Part 1 | Experimental | Period 1: Placebo Period 2: Dose 3 Period 3: Dose 5 Receives: Drug: Dose 3, AZD8871 300 μg (Part 1); Drug: Dose 5, AZD8871 1200 µg (Part 1); Drug: Placebo, AZD8871 placebo (Part 1) |
| Sequence 3, Part 1 | Experimental | Period 1: Dose 1 Period 2: Placebo Period 3: Dose 5 Receives: Drug: Dose 1, AZD8871 50 μg (Part 1); Drug: Dose 5, AZD8871 1200 µg (Part 1); Drug: Placebo, AZD8871 placebo (Part 1) |
| Sequence 4, Part 1 | Experimental | Period 1: Dose 1 Period 2: Dose 3 Period 3: Placebo Receives: Drug: Dose 1, AZD8871 50 μg (Part 1); Drug: Dose 3, AZD8871 300 μg (Part 1); Drug: Placebo, AZD8871 placebo (Part 1) |
| Sequence 5, Part 1 | Experimental | Period 1: Dose 2 Period 2: Dose 4 Period 3: Dose 6 Receives: Drug: Dose 2, AZD8871 100 μg (Part 1); Drug: Dose 4, AZD8871 600 µg (Part 1); Drug: Dose 6, AZD8871 1800 μg (Part 1) |
| Sequence 6, Part 1 | Experimental | Period 1: Placebo Period 2: Dose 4 Period 3: Dose 6 Receives: Drug: Dose 4, AZD8871 600 µg (Part 1); Drug: Dose 6, AZD8871 1800 μg (Part 1); Drug: Placebo, AZD8871 placebo (Part 1) |
| Sequence 7, Part 1 | Experimental | Period 1: Dose 2 Period 2: Placebo Period 3: Dose 6 Receives: Drug: Dose 2, AZD8871 100 μg (Part 1); Drug: Dose 6, AZD8871 1800 μg (Part 1); Drug: Placebo, AZD8871 placebo (Part 1) |
| Sequence 8, Part 1 | Experimental | Period 1: Dose 2 Period 2: Dose 4 Period 3: Placebo Receives: Drug: Dose 2, AZD8871 100 μg (Part 1); Drug: Dose 4, AZD8871 600 µg (Part 1); Drug: Placebo, AZD8871 placebo (Part 1) |
| Sequence 1, Part 2 | Experimental | Period 1: Treatment A Period 2: Treatment B Period 3: Treatment E Period 4: Treatment C Period 5: Treatment D Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
| Sequence 2, Part 2 | Experimental | Period 1: Treatment B Period 2: Treatment C Period 3: Treatment A Period 4: Treatment D Period 5: Treatment E Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
| Sequence 3, Part 2 | Experimental | Period 1: Treatment C Period 2: Treatment D Period 3: Treatment B Period 4: Treatment E Period 5: Treatment A Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
| Sequence 4, Part 2 | Experimental | Period 1: Treatment D Period 2: Treatment E Period 3: Treatment C Period 4: Treatment A Period 5: Treatment B Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
| Sequence 5, Part 2 | Experimental | Period 1: Treatment E Period 2: Treatment A Period 3: Treatment D Period 4: Treatment B Period 5: Treatment C Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
| Sequence 6, Part 2 | Experimental | Period 1: Treatment D Period 2: Treatment C Period 3: Treatment E Period 4: Treatment B Period 5: Treatment A Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
| Sequence 7, Part 2 | Experimental | Period 1: Treatment E Period 2: Treatment D Period 3: Treatment A Period 4: Treatment C Period 5: Treatment B Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
| Sequence 8, Part 2 | Experimental | Period 1: Treatment A Period 2: Treatment E Period 3: Treatment B Period 4: Treatment D Period 5: Treatment C Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
| Sequence 9, Part 2 | Experimental | Period 1: Treatment B Period 2: Treatment A Period 3: Treatment C Period 4: Treatment E Period 5: Treatment D Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
| Sequence 10, Part 2 | Experimental | Period 1: Treatment C Period 2: Treatment B Period 3: Treatment D Period 4: Treatment A Period 5: Treatment E Receives: Drug: Treatment A, AZD8871 dose A (Part 2); Drug: Treatment B, AZD8871 dose B (Part 2); Drug: Treatment C, Indacaterol 150 μg (Part 2); Drug: Treatment D, Tiotropium 18 μg (Part 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Mild Persistent Asthma (Part 1) and COPD (Part 2) With at Least 1 Treatment-emergent Adverse Event
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, signs, or the abnormal results of laboratory parameters (haematology, blood chemistry, urinalysis, physical examination, 12-lead ECGs and telemetry, and vital signs). AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.
Measured: From the time of informed consent up to 14 (±2) days after the last dose of investigational product. Unresolved AEs were followed up by the investigator for as long as medically indicated.
Number of Participants With Clinically Relevant Abnormalities in Blood Pressure
Blood pressure (BP) measurements (diastolic [DBP] and systolic BP [SBP]) taken after ~5 minutes rest in supine position, at screening, baseline (≤1 hour before IP administration), 10 and 30 minutes, 1, 2, 3, 4, 8, 12 hours (Day 1) and 24 and 36 hours (Day 2) after IP administration. Normal BP at screening: SBP 100-140 mmHg (subjects aged ≤59 years) and 100-150 mmHg (subjects aged ≥60 years), and DBP 40-90 mmHg.
Criteria for notable changes in BP:
High SBP: (≥180 and increase over baseline (predose) ≥20) or (≥200 and baseline <200) Low SBP: (≤ 90 and decrease over baseline ≥20) or (≤75 and baseline >75) High DBP: (≥105 and increase over baseline ≥15) or (≥115 and baseline <115) Low DBP: (≤50 and decrease over baseline ≥15) or (≤40 and baseline >40) All out of range values were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until considered non-clinically relevant.
Measured: From the time of informed consent up to 36 hours after last dose of IP.
Number of Participants With Clinically Relevant Abnormalities in Electrocardiograms (HR, QTcF and Other ECG Parameters).
HR, QTcF and other ECG abnormalities were assessed by local digital 12-lead ECG performed in triplicate at the time points indicated:
ECG (Parts 1 and 2) was assessed at Screening, Day 1 baseline, 10 min, 30 min, 1 hour (h), 2 h, 3 h, 4 h, 8 h, 12 h, 24 h, 36 h after dosing.
Telemetry (Part 1), assessed with at least 2 lead real time display, was recorded at Day -1 (4-6 hours continuous recording, at the time this was more convenient for the logistics of the unit) and on Day 1 from the time of the IP administration up to at least 24 hours, but if advised by the Investigator or designee, then up to 36 hours after IP administration.
Abnormal findings were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until the abnormality was considered non-clinically relevant.
Measured: From the time of informed consent up to 36 hours after last dose of IP.
Number of Participants With Clinically Relevant Abnormalities in Clinical Biochemistry, Hematology and Urinalysis
A composite of clinically relevant abnormalities in clinical biochemistry, hematology and urinalysis laboratory evaluations. Laboratory tests (haematology, blood chemistry, and urinalysis) were performed at screening, at Day -1 (Part 1 only), at 24 hours (Day 2) and at follow-up (7 [±2] days) after IP administration. Coagulation was only performed at screening; TSH, T4 only at screening, at Day-1 and at follow-up.
Abnormal findings were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until the abnormality was considered non-clinically relevant.
Measured: From the time of informed consent up to 7 days after the last dose of IP.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 2
Pharmacodynamics of AZD8871 before (-45 min and -15 min pre-dose) and after single dosing of AZD8871 Forced expiratory volume in 1 second (FEV1) on Day 2 (defined as the average of the values 23:00 and 24:00 hours after the morning dose of investigational product)
Measured: Baseline (Day 1) to 36 hours post-dose (Day 2)
Secondary outcomes (4)
Cmax of AZD8871 in Parts 1 and 2
Cmax (maximum observed plasma drug concentrations) of AZD8871 on Day 1 of each treatment period.
Measured: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose
Tmax of AZD8871 in Parts 1 and 2
tmax (time to reach maximum concentration) of AZD8871 on Day 1 of each treatment period.
Measured: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose
AUC(0-t) of AZD8871 in Parts 1 and 2
AUC(0-t) (area under the concentration-time curve from time zero to time of the last quantifiable measurable concentration) of AZD8871 on Day 1 of each treatment period.
Measured: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose
AUC(0-24) of AZD8871 in Parts 1 and 2
AUC(0-24) (area under the concentration-time curve from zero to 24h) of AZD8871 on Day 1 of each treatment period.
Measured: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma (Part 1)Studies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muna Albayaty, MBChB, MSc,MFPM, Principal investigator, PAREXEL Early Phase Clinical Unit, London, United KingdomDave Singh, Prof., Principal investigator, The Medicines Evaluation Unit (MEU), Manchester, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573155
- Sponsor's protocol ID
- D6640C00001
- Other IDs
- 2015-002906-36, 2015
- Status last verified
- Apr 2018
- First submitted
- 8 Oct 2015
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jimenez E, Astbury C, Albayaty M, Wahlby-Hamren U, Seoane B, Villarroel C, Pujol H, Bermejo MJ, Aggarwal A, Psallidas I. Navafenterol (AZD8871) in patients with mild asthma: a randomised placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of this novel inhaled long-acting dual-pharmacology bronchodilator. Respir Res. 2020 Sep 9;21(Suppl 1):211. doi: 10.1186/s12931-020-01470-5.
PubMed 32907576Singh D, Balaguer V, Astbury C, Wahlby-Hamren U, Jimenez E, Seoane B, Villarroel C, Lei A, Aggarwal A, Psallidas I. Navafenterol (AZD8871) in patients with COPD: a randomized, double-blind, phase I study evaluating safety and pharmacodynamics of single doses of this novel, inhaled, long-acting, dual-pharmacology bronchodilator. Respir Res. 2020 Sep 9;21(Suppl 1):102. doi: 10.1186/s12931-020-01347-7.
PubMed 32907566
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02573155
- Acronym / sponsor ID
- D6640C00001
- Conditions
- Asthma (Part 1), COPD (Part 2)
- Keywords
- Pharmacokinetics, Pharmacodynamics, AZD8871, Safety, Tolerability, mild persistent asthma, moderate to severe COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Posted 8 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is an integrated Phase I protocol divided into 2 parts.
Part 1: single ascending dose study (6 AZD8871 dose levels) in 16 male subjects with mild asthma. AZD8871 will be administered (by the Genuair® inhaler) under supervision at the study centre, according to the randomisation scheme
Part 2: a 5 treatment period single dose study (of AZD8871 [two doses], indacaterol, tiotropium and placebo) in 40 male and non-childbearing female subjects with moderate to severe COPD. Each treatment period will be separated by a washout period of at least 7 days. The primary comparison for bronchodilation will be between AZD8871 doses and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Sequence 1, Part 1 | Experimental | Drug: Dose 1, AZD8871 50 μg (Part 1), Drug: Dose 3, AZD8871 300 μg (Part 1), Drug: Dose 5, AZD8871 1200 µg (Part 1)Period 1: Dose 1 Period 2: Dose 3 Period 3: Dose 5 |
| Sequence 2, Part 1 | Experimental | Drug: Dose 3, AZD8871 300 μg (Part 1), Drug: Dose 5, AZD8871 1200 µg (Part 1), Drug: Placebo, AZD8871 placebo (Part 1)Period 1: Placebo Period 2: Dose 3 Period 3: Dose 5 |
| Sequence 3, Part 1 | Experimental | Drug: Dose 1, AZD8871 50 μg (Part 1), Drug: Dose 5, AZD8871 1200 µg (Part 1), Drug: Placebo, AZD8871 placebo (Part 1)Period 1: Dose 1 Period 2: Placebo Period 3: Dose 5 |
| Sequence 4, Part 1 | Experimental | Drug: Dose 1, AZD8871 50 μg (Part 1), Drug: Dose 3, AZD8871 300 μg (Part 1), Drug: Placebo, AZD8871 placebo (Part 1)Period 1: Dose 1 Period 2: Dose 3 Period 3: Placebo |
| Sequence 5, Part 1 | Experimental | Drug: Dose 2, AZD8871 100 μg (Part 1), Drug: Dose 4, AZD8871 600 µg (Part 1), Drug: Dose 6, AZD8871 1800 μg (Part 1)Period 1: Dose 2 Period 2: Dose 4 Period 3: Dose 6 |
| Sequence 6, Part 1 | Experimental | Drug: Dose 4, AZD8871 600 µg (Part 1), Drug: Dose 6, AZD8871 1800 μg (Part 1), Drug: Placebo, AZD8871 placebo (Part 1)Period 1: Placebo Period 2: Dose 4 Period 3: Dose 6 |
| Sequence 7, Part 1 | Experimental | Drug: Dose 2, AZD8871 100 μg (Part 1), Drug: Dose 6, AZD8871 1800 μg (Part 1), Drug: Placebo, AZD8871 placebo (Part 1)Period 1: Dose 2 Period 2: Placebo Period 3: Dose 6 |
| Sequence 8, Part 1 | Experimental | Drug: Dose 2, AZD8871 100 μg (Part 1), Drug: Dose 4, AZD8871 600 µg (Part 1), Drug: Placebo, AZD8871 placebo (Part 1)Period 1: Dose 2 Period 2: Dose 4 Period 3: Placebo |
| Sequence 1, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment A Period 2: Treatment B Period 3: Treatment E Period 4: Treatment C Period 5: Treatment D |
| Sequence 2, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment B Period 2: Treatment C Period 3: Treatment A Period 4: Treatment D Period 5: Treatment E |
| Sequence 3, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment C Period 2: Treatment D Period 3: Treatment B Period 4: Treatment E Period 5: Treatment A |
| Sequence 4, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment D Period 2: Treatment E Period 3: Treatment C Period 4: Treatment A Period 5: Treatment B |
| Sequence 5, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment E Period 2: Treatment A Period 3: Treatment D Period 4: Treatment B Period 5: Treatment C |
| Sequence 6, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment D Period 2: Treatment C Period 3: Treatment E Period 4: Treatment B Period 5: Treatment A |
| Sequence 7, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment E Period 2: Treatment D Period 3: Treatment A Period 4: Treatment C Period 5: Treatment B |
| Sequence 8, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment A Period 2: Treatment E Period 3: Treatment B Period 4: Treatment D Period 5: Treatment C |
| Sequence 9, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment B Period 2: Treatment A Period 3: Treatment C Period 4: Treatment E Period 5: Treatment D |
| Sequence 10, Part 2 | Experimental | Drug: Treatment A, AZD8871 dose A (Part 2), Drug: Treatment B, AZD8871 dose B (Part 2), Drug: Treatment C, Indacaterol 150 μg (Part 2), Drug: Treatment D, Tiotropium 18 μg (Part 2)Period 1: Treatment C Period 2: Treatment B Period 3: Treatment D Period 4: Treatment A Period 5: Treatment E |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Subjects who are able and willing to provide written informed consent prior to conducting any study-related procedures, including withdrawal of medications
- Adult male subjects aged 18 to 70 years (both inclusive)
- Body mass index (BMI) from 18 to 32 kg/m2 at screening
- Clinical diagnosis of asthma (according to the Global Initiative for Asthma [GINA] guidelines) for at least 6 months prior to screening
- Ability to change current asthma therapy, to discontinue previous prescribed medications after signature of informed consent as per required washout periods
Key exclusion criteria (30 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrolment or randomisation of treatment in the present study
- Current evidence or recent history of any clinically significant and unstable disease (other than asthma/COPD) or abnormality that could put the subject at risk or could confound the results of the study
- Subjects with a surgical history clinically relevant for the purpose of the study
- History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin
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 |
|---|---|---|
| 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 | Sequence 1, Part 1, Sequence 3, Part 1, Sequence 4, Part 1 |
| 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 | Sequence 5, Part 1, Sequence 7, Part 1, Sequence 8, Part 1 |
| 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 | Sequence 1, Part 1, Sequence 2, Part 1, Sequence 4, Part 1 |
| 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 | Sequence 5, Part 1, Sequence 6, Part 1, Sequence 8, Part 1 |
| 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 | Sequence 1, Part 1, Sequence 2, Part 1, Sequence 3, Part 1 |
| 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 | Sequence 5, Part 1, Sequence 6, Part 1, Sequence 7, Part 1 |
| 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 | Sequence 2, Part 1, Sequence 3, Part 1, Sequence 4, Part 1, Sequence 6, Part 1, Sequence 7, Part 1, Sequence 8, Part 1 |
| 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 | Sequence 1, Part 2, Sequence 10, Part 2, Sequence 2, Part 2, Sequence 3, Part 2, Sequence 4, Part 2, Sequence 5, Part 2, Sequence 6, Part 2, Sequence 7, Part 2, Sequence 8, Part 2, Sequence 9, Part 2 |
| 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 | Sequence 1, Part 2, Sequence 10, Part 2, Sequence 2, Part 2, Sequence 3, Part 2, Sequence 4, Part 2, Sequence 5, Part 2, Sequence 6, Part 2, Sequence 7, Part 2, Sequence 8, Part 2, Sequence 9, Part 2 |
| 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 | Sequence 1, Part 2, Sequence 10, Part 2, Sequence 2, Part 2, Sequence 3, Part 2, Sequence 4, Part 2, Sequence 5, Part 2, Sequence 6, Part 2, Sequence 7, Part 2, Sequence 8, Part 2, Sequence 9, Part 2 |
| 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 | Drug | Sequence 1, Part 2, Sequence 10, Part 2, Sequence 2, Part 2, Sequence 3, Part 2, Sequence 4, Part 2, Sequence 5, Part 2, Sequence 6, Part 2, Sequence 7, Part 2, Sequence 8, Part 2, Sequence 9, Part 2 |
Primary outcome
The Number of Participants With Mild Persistent Asthma (Part 1) and COPD (Part 2) With at Least 1 Treatment-emergent Adverse Event
Time frame: From the time of informed consent up to 14 (±2) days after the last dose of investigational product. Unresolved AEs were followed up by the investigator for as long as medically indicated.
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, signs, or the abnormal results of laboratory parameters (haematology, blood chemistry, urinalysis, physical examination, 12-lead ECGs and telemetry, and vital signs). AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.
Number of Participants With Clinically Relevant Abnormalities in Blood Pressure
Time frame: From the time of informed consent up to 36 hours after last dose of IP.
Blood pressure (BP) measurements (diastolic [DBP] and systolic BP [SBP]) taken after ~5 minutes rest in supine position, at screening, baseline (≤1 hour before IP administration), 10 and 30 minutes, 1, 2, 3, 4, 8, 12 hours (Day 1) and 24 and 36 hours (Day 2) after IP administration. Normal BP at screening: SBP 100-140 mmHg (subjects aged ≤59 years) and 100-150 mmHg (subjects aged ≥60 years), and DBP 40-90 mmHg. Criteria for notable changes in BP: High SBP: (≥180 and increase over baseline (predose) ≥20) or (≥200 and baseline <200) Low SBP: (≤ 90 and decrease over baseline ≥20) or (≤75 and baseline >75) High DBP: (≥105 and increase over baseline ≥15) or (≥115 and baseline <115) Low DBP: (≤50 and decrease over baseline ≥15) or (≤40 and baseline >40) All out of range values were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until considered non-clinically relevant.
Number of Participants With Clinically Relevant Abnormalities in Electrocardiograms (HR, QTcF and Other ECG Parameters).
Time frame: From the time of informed consent up to 36 hours after last dose of IP.
HR, QTcF and other ECG abnormalities were assessed by local digital 12-lead ECG performed in triplicate at the time points indicated: ECG (Parts 1 and 2) was assessed at Screening, Day 1 baseline, 10 min, 30 min, 1 hour (h), 2 h, 3 h, 4 h, 8 h, 12 h, 24 h, 36 h after dosing. Telemetry (Part 1), assessed with at least 2 lead real time display, was recorded at Day -1 (4-6 hours continuous recording, at the time this was more convenient for the logistics of the unit) and on Day 1 from the time of the IP administration up to at least 24 hours, but if advised by the Investigator or designee, then up to 36 hours after IP administration. Abnormal findings were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until the abnormality was considered non-clinically relevant.
Number of Participants With Clinically Relevant Abnormalities in Clinical Biochemistry, Hematology and Urinalysis
Time frame: From the time of informed consent up to 7 days after the last dose of IP.
A composite of clinically relevant abnormalities in clinical biochemistry, hematology and urinalysis laboratory evaluations. Laboratory tests (haematology, blood chemistry, and urinalysis) were performed at screening, at Day -1 (Part 1 only), at 24 hours (Day 2) and at follow-up (7 [±2] days) after IP administration. Coagulation was only performed at screening; TSH, T4 only at screening, at Day-1 and at follow-up. Abnormal findings were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until the abnormality was considered non-clinically relevant.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 2
Time frame: Baseline (Day 1) to 36 hours post-dose (Day 2)
Pharmacodynamics of AZD8871 before (-45 min and -15 min pre-dose) and after single dosing of AZD8871 Forced expiratory volume in 1 second (FEV1) on Day 2 (defined as the average of the values 23:00 and 24:00 hours after the morning dose of investigational product)
4 secondary outcomes
Cmax of AZD8871 in Parts 1 and 2
Time frame: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose
Tmax of AZD8871 in Parts 1 and 2
Time frame: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose
AUC(0-t) of AZD8871 in Parts 1 and 2
Time frame: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose
AUC(0-24) of AZD8871 in Parts 1 and 2
Time frame: Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32907576Jimenez E, Astbury C, Albayaty M, Wahlby-Hamren U, Seoane B, Villarroel C, Pujol H, Bermejo MJ, Aggarwal A, Psallidas I. Navafenterol (AZD8871) in patients with mild asthma: a randomised placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of this novel inhaled long-acting dual-pharmacology bronchodilator. Respir Res. 2020 Sep 9;21(Suppl 1):211. doi: 10.1186/s12931-020-01470-5.
- Derived from this study: PubMed 32907566Singh D, Balaguer V, Astbury C, Wahlby-Hamren U, Jimenez E, Seoane B, Villarroel C, Lei A, Aggarwal A, Psallidas I. Navafenterol (AZD8871) in patients with COPD: a randomized, double-blind, phase I study evaluating safety and pharmacodynamics of single doses of this novel, inhaled, long-acting, dual-pharmacology bronchodilator. Respir Res. 2020 Sep 9;21(Suppl 1):102. doi: 10.1186/s12931-020-01347-7.
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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.
Muna Albayaty, MBChB, MSc,MFPM principal investigator
PAREXEL Early Phase Clinical Unit, London, United Kingdom
Dave Singh, Prof. principal investigator
The Medicines Evaluation Unit (MEU), Manchester, United Kingdom
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose 1, AZD8871 50 μg (Part 1), Dose 2, AZD8871 100 μg (Part 1) and Dose 3, AZD8871 300 μg (Part 1) in people with Asthma (Part 1) and COPD (Part 2), run by AstraZeneca at 2 sites in United Kingdom.
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 29 inclusion and 30 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. 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?
Yes. Results are posted in the registry (first posted 8 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants With Mild Persistent Asthma (Part 1) and COPD (Part 2) With at Least 1 Treatment-emergent Adverse Event (time frame: From the time of informed consent up to 14 (±2) days after the last dose of investigational product. Unresolved AEs were followed up by the investigator for as long as medically indicated.). The study lists 5 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 NCT02573155, which also lists 2 linked publications.
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 8 Nov 2018.