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

Pearl Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo MDI; Drug: AZD 2115, Dose 2; Drug: AZD2115 Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02109406

AZD2115 D3060C00006

Details and patient eligibility

About

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).

Enrollment: 31 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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31 participants in 3 patient groups, including a placebo group

AZD2115 Dose 1

Experimental group

Description:

AZD 2115, Dose 1 administered as two inhalations BID

Treatment:

Drug: AZD2115 Dose 1

AZD 2115 Dose 2

Experimental group

Description:

AZD 2115, Dose 2 administered as two inhalations BID

Treatment:

Drug: AZD 2115, Dose 2

Placebo MDI

Placebo Comparator group

Description:

Placebo MDI administered as two inhalations BID

Treatment:

Drug: Placebo MDI