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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Randomized, Double Blind, Chronic Dosing (14 Days), Three Period, Placebo Controlled, Cross Over, Multi Center Study to Assess Efficacy and Safety of Two Dose Levels of AZD2115 MDI in Subjects With Moderate to Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109406
• Other study ID #: AZD2115 D3060C00006
• Status: Completed
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: August 2020
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD2115 Dose 1
AZD 2115, Dose 1 administered as two inhalations BID
• AZD 2115, Dose 2
AZD 2115, Dose 2 administered as two inhalations BID
• Placebo MDI
Placebo MDI administered as two inhalations BID

Locations

Country	Name	City	State
United States	Pearl Therapeutics Study Site	Charleston	South Carolina
United States	Pearl Therapeutics Study Site	Clearwater	Florida
United States	Pearl Therapeutics Study Site	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetics	Cmax, AUC0-12, AUC0-t, tmax, Apparent elimination half-life (t1/2), Apparent volume of distribution (Vd/F), Apparent total body clearance (CL/F)	Day 1 through Day 15
Other	Safety	Safety will be assessed by adverse events (AEs), physical examination findings, dry mouth and tremor assessments, paradoxical bronchospasm, vital signs, electrocardiogram (ECG), and laboratory assessments.	Day1 through Day 15
Primary	Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline		14 Days
Secondary	Change from baseline in morning pre dose trough FEV1		14 Days
Secondary	Peak change in FEV1		14 Days
Secondary	Forced vital capacity (FVC) AUC0-12 relative to baseline		14 Days
Secondary	Peak change in FEV1		Day 1
Secondary	Change from baseline in 12-hour post dose trough FEV1		14 Days
Secondary	Time to onset of action		Day 1