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

NCT02109406 | Completed Phase 2

• 1 other identifier: AZD2115 D3060C00006
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline

  14 Days

Secondary Outcomes (6)

• Change from baseline in morning pre dose trough FEV1

  14 Days

• Peak change in FEV1

  14 Days

• Forced vital capacity (FVC) AUC0-12 relative to baseline

  14 Days

• Peak change in FEV1

  Day 1

• Change from baseline in 12-hour post dose trough FEV1

  14 Days

Other Outcomes (2)

• Pharmacokinetics

  Day 1 through Day 15

• Safety

  Day1 through Day 15

Study Arms (3)

AZD2115 Dose 1

EXPERIMENTAL

AZD 2115, Dose 1 administered as two inhalations BID

Drug: AZD2115 Dose 1

AZD 2115 Dose 2

EXPERIMENTAL

AZD 2115, Dose 2 administered as two inhalations BID

Drug: AZD 2115, Dose 2

Placebo MDI

PLACEBO COMPARATOR

Placebo MDI administered as two inhalations BID

Drug: Placebo MDI

Interventions

AZD2115 Dose 1 DRUG

AZD 2115, Dose 1 administered as two inhalations BID

AZD2115 Dose 1

AZD 2115, Dose 2 DRUG

AZD 2115, Dose 2 administered as two inhalations BID

AZD 2115 Dose 2

Placebo MDI DRUG

Placebo MDI administered as two inhalations BID

Placebo MDI

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (3)

Pearl Therapeutics Study Site

Clearwater, Florida, United States

Location

Pearl Therapeutics Study Site

Charleston, South Carolina, United States

Location

Pearl Therapeutics Study Site

Spartanburg, South Carolina, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shahid Siddiqui, MD

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 9, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (3)