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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01498081
First received: December 21, 2011
Last updated: October 25, 2012
Last verified: October 2012

December 21, 2011
October 25, 2012
March 2012
October 2012   (final data collection date for primary outcome measure)
  • Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments [ Time Frame: During the first 24 hours following administration ] [ Designated as safety issue: No ]
  • Trough FEV1defined as the average FEV1 from the spirometry assessments [ Time Frame: During 22 to 26 hours following administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01498081 on ClinicalTrials.gov Archive Site
  • Average FEV1 [ Time Frame: FEV1 0-24h post-dose ] [ Designated as safety issue: No ]
  • Peak, average and trough Forced Vital Capacity (FVC) [ Time Frame: FVC peak and average 0-24h post-dose and trough 22-26h post-dose ] [ Designated as safety issue: No ]
  • Systemic effect by assessment of blood pressure (BP) [ Time Frame: Peak and average 0-4 h post dose ] [ Designated as safety issue: No ]
  • Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF) [ Time Frame: Peak and average 0-4 h post dose ] [ Designated as safety issue: No ]
  • Systemic effect by assessment of Potassium and Glucose [ Time Frame: Peak and average 0-4 h post dose ] [ Designated as safety issue: No ]
  • Safety and tolerability of 3 different single doses of AZD2115 [ Time Frame: At screening, during 0-26 h post-dose and at follow-up ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 0-24h post dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
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)

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.

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)

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
COPD
  • Drug: AZD2115
    AZD2115 administered via inhalation
  • Drug: Placebo
    Placebo administered via inhalation
  • Drug: Indacaterol
    Indacaterol administered via inhalation
  • Drug: Indacaterol + Tiotropium
    Indacaterol + Tiotropium administered inhalation
  • Experimental: Single dose of AZD2115 25 µg
    Intervention: Drug: AZD2115
  • Experimental: Single dose of AZD2115 80 µg
    Intervention: Drug: AZD2115
  • Experimental: Single dose of AZD2115 240 µg
    Intervention: Drug: AZD2115
  • Placebo Comparator: Single doses of placebo
    Intervention: Drug: Placebo
  • Active Comparator: Single dose of indacaterol 150 µg
    Intervention: Drug: Indacaterol
  • Active Comparator: Single dose of indacaterol 150 µg + tiotropium 18 µg
    Intervention: Drug: Indacaterol + Tiotropium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
October 2012
October 2012   (final data collection date for primary outcome measure)

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%.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Sweden
 
NCT01498081
D3060C00003, EudraCT number: 2011-004641-41
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Carin Jorup, MD AstraZeneca R&D Molndal, Sweden
AstraZeneca
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP