Clinical trial NCT01498081: A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Keywords: COPD, pulmonary disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)

Eligibility criteria: 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%.

Primary outcomes:
measure: Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments
timeFrame: During the first 24 hours following administration
measure: Trough FEV1defined as the average FEV1 from the spirometry assessments
timeFrame: During 22 to 26 hours following administration
Secondary outcomes:
measure: Average FEV1
timeFrame: FEV1 0-24h post-dose
measure: Peak, average and trough Forced Vital Capacity (FVC)
timeFrame: FVC peak and average 0-24h post-dose and trough 22-26h post-dose
measure: Systemic effect by assessment of blood pressure (BP)
timeFrame: Peak and average 0-4 h post dose
measure: Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF)
timeFrame: Peak and average 0-4 h post dose
measure: Systemic effect by assessment of Potassium and Glucose
timeFrame: Peak and average 0-4 h post dose
measure: Safety and tolerability of 3 different single doses of AZD2115
timeFrame: At screening, during 0-26 h post-dose and at follow-up
measure: 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)
timeFrame: 0-24h post dose
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Research Site
city: Leczna
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Proszowice
country: Poland
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Molndal, Sweden
name: Carin Jorup, MD
role: STUDY_DIRECTOR
References: