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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: AZD2115 Dose 1; Drug: AZD 2115, Dose 2; Drug: Placebo MDI

• Registration Number: NCT02109406
• Lead Sponsor: Pearl Therapeutics, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-09
• Study Start: 2014-05
• Disposition First Submitted: 2014-07-15
• Disposition First Submitted QC: 2014-07-16
• Disposition First Posted: 2014-07-18
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-28
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AZD2115 Dose 1	AZD2115 Dose 1	AZD 2115, Dose 1 administered as two inhalations BID
AZD 2115 Dose 2	AZD 2115, Dose 2	AZD 2115, Dose 2 administered as two inhalations BID
Placebo MDI	Placebo MDI	Placebo MDI administered as two inhalations BID

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline	14 Days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in morning pre dose trough FEV1	14 Days
Time to onset of action	Day 1
Peak change in FEV1	Day 1
Forced vital capacity (FVC) AUC0-12 relative to baseline	14 Days
Change from baseline in 12-hour post dose trough FEV1	14 Days

Trial Locations

Locations (1)

Pearl Therapeutics Study Site; 🇺🇸 Spartanburg, South Carolina, United States