COPD
Conditions
Keywords
COPD, pulmonary disease
Brief summary
This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated.
Detailed description
A randomised, double-blind, placebo and active controlled, multi-centre, 6 way cross-over, single-dose Phase IIa study to investigate the local and systemic effects of 3 different doses of inhaled AZD2115 in patients with chronic obstructive pulmonary disease (COPD)
Interventions
DRUGPlacebo
Placebo administered via inhalation
DRUGAZD2115
AZD2115 administered via inhalation
DRUGIndacaterol
Indacaterol administered via inhalation
DRUGIndacaterol + Tiotropium
Indacaterol + Tiotropium administered inhalation
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures * Male or female of non-childbearing potential (post-menopausal or surgically sterilised), age ≥40 years at Visit 1 * Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines * Post-bronchodilator FEV1 ≥ 40 to \< 80% of the predicted normal value and post-bronchodilator FEV1/FVC \< 70% * Reversible airway obstruction
Exclusion criteria
* Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study. * An exacerbation of COPD within 6 weeks prior to Visit 1 * Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2. * Recent or ongoing respiratory tract infection during enrolment period. * Need for long-term oxygen therapy and/or saturation O2 \< 92%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments | During the first 24 hours following administration |
| Trough FEV1defined as the average FEV1 from the spirometry assessments | During 22 to 26 hours following administration |
Secondary
| Measure | Time frame |
|---|---|
| Systemic effect by assessment of blood pressure (BP) | Peak and average 0-4 h post dose |
| Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF) | Peak and average 0-4 h post dose |
| Average FEV1 | FEV1 0-24h post-dose |
| Safety and tolerability of 3 different single doses of AZD2115 | At screening, during 0-26 h post-dose and at follow-up |
| Plasma concentrations of AZD2115 after 3 different single doses measured as area under the curve over the time (AUC) and maximum concentration (Cmax), and time to maximum concentration (tmax) | 0-24h post dose |
| Systemic effect by assessment of Potassium and Glucose | Peak and average 0-4 h post dose |
| Peak, average and trough Forced Vital Capacity (FVC) | FVC peak and average 0-24h post-dose and trough 22-26h post-dose |
Countries
Poland, Sweden
Outcome results
None listed