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AZD2115

Phase 2

COPD | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Oct 26, 2012

AZD2115 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Jan 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment135

FDA Designations

No designations recorded

AZD2115 clinical trials

AZD2115 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT01498081A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD PatientsCOPD
COMPLETED39 Analytics
PHASE2COMPLETED
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
COPDUnlock trial analytics

Study Endpoints

Primary Endpoints

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
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Measurements will be taken at screening
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Measurements will be taken at screening
To evaluate the vital signs of inhaled single doses of AZD2115
Measurements will be taken at screening
To evaluate the physical examination of inhaled single doses of AZD2115
Measurements will be taken at screening
To evaluate the ECG of inhaled single doses of AZD2115
Measurements will be taken at screening

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single dose of AZD2115 25 µgEXPERIMENTAL -
Single dose of AZD2115 80 µgEXPERIMENTAL -
Single dose of AZD2115 240 µgEXPERIMENTAL -
Single doses of placeboPLACEBO_COMPARATOR -
Single dose of indacaterol 150 µgACTIVE_COMPARATOR -
Single dose of indacaterol 150 µg + tiotropium 18 µgACTIVE_COMPARATOR -
1EXPERIMENTALAZD2115
2PLACEBO_COMPARATORPlacebo to AZD2115

Interventions

NameTypeDescription
AZD2115DRUGAZD2115 administered via inhalation
PlaceboDRUGPlacebo administered via inhalation
IndacaterolDRUGIndacaterol administered via inhalation
Indacaterol + TiotropiumDRUGIndacaterol + Tiotropium administered inhalation
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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 *...

Countries:PolandSwedenUnited Kingdom
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Frequently asked questions about AZD2115

What is AZD2115 used for?

AZD2115 is an investigational inhaled small molecule being studied for the treatment of chronic obstructive pulmonary disease (COPD). It is not approved for any indication and remains in clinical development, with studies conducted in COPD patients and in healthy volunteers.

Who is developing AZD2115?

AZD2115 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company sponsored the clinical studies of the drug in COPD and in healthy volunteers.

What phase is AZD2115 in?

AZD2115 has reached Phase 2 clinical development. A Phase 2 study of inhaled AZD2115 in COPD patients has been completed, and a Phase 1 single ascending dose study has also been completed. The drug is investigational and has not been approved by the FDA.

What clinical trials has AZD2115 been studied in?

AZD2115 has been evaluated in two completed trials. NCT01498081 was a Phase 2, randomized, double-blind, placebo-controlled single-dose study of three inhaled dose levels in 39 COPD patients in Poland and Sweden. NCT01283984 was a Phase 1 single ascending dose study in 96 healthy male volunteers in the United Kingdom.

How was the Phase 2 trial of AZD2115 designed?

The Phase 2 trial, NCT01498081, was a single-dose study investigating three different doses of inhaled AZD2115 in COPD patients. It was randomized, double-blind, and placebo-controlled, enrolled 39 participants aged 40 years and older, and was conducted in Poland and Sweden. The study has been completed.