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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
  Purpose
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.

Condition Intervention Phase
COPD Drug: AZD2115 Drug: Placebo Drug: Indacaterol Drug: Indacaterol + Tiotropium Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]
  • Trough FEV1defined as the average FEV1 from the spirometry assessments [ Time Frame: During 22 to 26 hours following administration ]

Secondary Outcome Measures:
  • Average FEV1 [ Time Frame: FEV1 0-24h post-dose ]
  • Peak, average and trough Forced Vital Capacity (FVC) [ Time Frame: FVC peak and average 0-24h post-dose and trough 22-26h post-dose ]
  • Systemic effect by assessment of blood pressure (BP) [ Time Frame: 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) [ Time Frame: Peak and average 0-4 h post dose ]
  • Systemic effect by assessment of Potassium and Glucose [ Time Frame: Peak and average 0-4 h post dose ]
  • Safety and tolerability of 3 different single doses of AZD2115 [ Time Frame: 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) [ Time Frame: 0-24h post dose ]

Enrollment: 39
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single dose of AZD2115 25 µg Drug: AZD2115
AZD2115 administered via inhalation
Experimental: Single dose of AZD2115 80 µg Drug: AZD2115
AZD2115 administered via inhalation
Experimental: Single dose of AZD2115 240 µg Drug: AZD2115
AZD2115 administered via inhalation
Placebo Comparator: Single doses of placebo Drug: Placebo
Placebo administered via inhalation
Active Comparator: Single dose of indacaterol 150 µg Drug: Indacaterol
Indacaterol administered via inhalation
Active Comparator: Single dose of indacaterol 150 µg + tiotropium 18 µg Drug: Indacaterol + Tiotropium
Indacaterol + Tiotropium administered inhalation

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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498081

Locations
Poland
Research Site
Bialystok, Poland
Research Site
Leczna, Poland
Research Site
Lodz, Poland
Research Site
Proszowice, Poland
Sweden
Research Site
Goteborg, Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carin Jorup, MD AstraZeneca R&D Molndal, Sweden
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01498081     History of Changes
Other Study ID Numbers: D3060C00003
EudraCT number: 2011-004641-41
Study First Received: December 21, 2011
Last Updated: October 25, 2012

Keywords provided by AstraZeneca:
COPD, pulmonary disease

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017