Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-09-30

Brief Summary

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This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115) delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD2115 Dose 1

AZD 2115, Dose 1 administered as two inhalations BID

Group Type EXPERIMENTAL

AZD2115 Dose 1

Intervention Type DRUG

AZD 2115, Dose 1 administered as two inhalations BID

AZD 2115 Dose 2

AZD 2115, Dose 2 administered as two inhalations BID

Group Type EXPERIMENTAL

AZD 2115, Dose 2

Intervention Type DRUG

AZD 2115, Dose 2 administered as two inhalations BID

Placebo MDI

Placebo MDI administered as two inhalations BID

Group Type PLACEBO_COMPARATOR

Placebo MDI

Intervention Type DRUG

Placebo MDI administered as two inhalations BID

Interventions

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AZD2115 Dose 1

AZD 2115, Dose 1 administered as two inhalations BID

Intervention Type DRUG

AZD 2115, Dose 2

AZD 2115, Dose 2 administered as two inhalations BID

Intervention Type DRUG

Placebo MDI

Placebo MDI administered as two inhalations BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic Obstructive Pulmonary Disease Diagnosis: Subjects with an established clinical history of COPD for more than 1 year at Screening, according to the COPD GOLD guidelines.
* Current or former smokers with a history of ≥10 pack years of cigarette smoking.
* Post-bronchodilator FEV1/FVC ratio of \<70%.
* Pre-bronchodilator FEV1 must be \<80% predicted
* Women of non-child bearing potential (ie., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or women of child bearing potential, has a negative serum pregnancy test at Screening and agrees to acceptable contraceptive methods for the duration of the study.

Exclusion Criteria

* Pregnancy: Women who are pregnant or lactating.
* Significant diseases other than COPD, ie., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
* Primary diagnosis of asthma.
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea.
* Poorly controlled COPD (hospitalization due to poorly controlled COPD within 3 months of Screening or requiring treatment with corticosteroids or antibiotics in the 6 week interval prior to Screening or during Screening.
* Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of Randomization.
* Clinically significant abnormal ECG.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No