Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic… (NCT02573155) | Clinical Trial Compass
CompletedPhase 1
Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects
United Kingdom134 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
The Number of Participants With Mild Persistent Asthma (Part 1) and COPD (Part 2) With at Least 1 Treatment-emergent Adverse Event
Timeframe: 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.
2
Number of Participants With Clinically Relevant Abnormalities in Blood Pressure
Timeframe: From the time of informed consent up to 36 hours after last dose of IP.
3
Number of Participants With Clinically Relevant Abnormalities in Electrocardiograms (HR, QTcF and Other ECG Parameters).
Timeframe: From the time of informed consent up to 36 hours after last dose of IP.
4
Number of Participants With Clinically Relevant Abnormalities in Clinical Biochemistry, Hematology and Urinalysis
Timeframe: From the time of informed consent up to 7 days after the last dose of IP.
5
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 2
Timeframe: Baseline (Day 1) to 36 hours post-dose (Day 2)
✕. 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)
✕. 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