A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients

COPD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498081
• Other study ID #: D3060C00003
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2011
• Last updated: October 25, 2012
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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%.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD2115
AZD2115 administered via inhalation
• Placebo
Placebo administered via inhalation
• Indacaterol
Indacaterol administered via inhalation
• Indacaterol + Tiotropium
Indacaterol + Tiotropium administered inhalation

Locations

Country	Name	City	State
Poland	Research Site	Bialystok
Poland	Research Site	Leczna
Poland	Research Site	Lodz
Poland	Research Site	Proszowice
Sweden	Research Site	Goteborg
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments		During the first 24 hours following administration	No
Primary	Trough FEV1defined as the average FEV1 from the spirometry assessments		During 22 to 26 hours following administration	No
Secondary	Average FEV1		FEV1 0-24h post-dose	No
Secondary	Peak, average and trough Forced Vital Capacity (FVC)		FVC peak and average 0-24h post-dose and trough 22-26h post-dose	No
Secondary	Systemic effect by assessment of blood pressure (BP)		Peak and average 0-4 h post dose	No
Secondary	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	No
Secondary	Systemic effect by assessment of Potassium and Glucose		Peak and average 0-4 h post dose	No
Secondary	Safety and tolerability of 3 different single doses of AZD2115		At screening, during 0-26 h post-dose and at follow-up	No
Secondary	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	No