Text Size

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
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Sweden: Medical Products Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by AstraZeneca:
COPD, pulmonary disease

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

ClinicalTrials.gov processed this record on May 21, 2013