NCT01498081

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

December 21, 2011

Last Update Submit

October 25, 2012

Conditions

COPD

Keywords

COPD, pulmonary disease

Outcome Measures

Primary Outcomes (2)

  • Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments

    During the first 24 hours following administration

  • Trough FEV1defined as the average FEV1 from the spirometry assessments

    During 22 to 26 hours following administration

Secondary Outcomes (7)

  • Average FEV1

    FEV1 0-24h post-dose

  • Peak, average and trough Forced Vital Capacity (FVC)

    FVC peak and average 0-24h post-dose and trough 22-26h post-dose

  • Systemic effect by assessment of blood pressure (BP)

    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)

    Peak and average 0-4 h post dose

  • Systemic effect by assessment of Potassium and Glucose

    Peak and average 0-4 h post dose

  • +2 more secondary outcomes

Study Arms (6)

Single dose of AZD2115 25 µg

EXPERIMENTAL
Drug: AZD2115

Single dose of AZD2115 80 µg

EXPERIMENTAL
Drug: AZD2115

Single dose of AZD2115 240 µg

EXPERIMENTAL
Drug: AZD2115

Single doses of placebo

PLACEBO COMPARATOR
Drug: Placebo

Single dose of indacaterol 150 µg

ACTIVE COMPARATOR
Drug: Indacaterol

Single dose of indacaterol 150 µg + tiotropium 18 µg

ACTIVE COMPARATOR
Drug: Indacaterol + Tiotropium

Interventions

AZD2115DRUG

AZD2115 administered via inhalation

Single dose of AZD2115 240 µgSingle dose of AZD2115 25 µgSingle dose of AZD2115 80 µg
PlaceboDRUG

Placebo administered via inhalation

Single doses of placebo
IndacaterolDRUG

Indacaterol administered via inhalation

Single dose of indacaterol 150 µg
Indacaterol + TiotropiumDRUG

Indacaterol + Tiotropium administered inhalation

Single dose of indacaterol 150 µg + tiotropium 18 µg

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Bialystok, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Proszowice, Poland

Location

Research Site

Łęczna, Poland

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Lund, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases

Interventions

indacaterolTiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Carin Jorup, MD

    AstraZeneca R&D Molndal, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 23, 2011

Study Start

March 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

PL(4)SE(2)