Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatments azd2115 dose 1, azd 2115, dose 2, placebo mdi
Phase phase 2
Sponsor Pearl Therapeutics, Inc.
Start date May 2014
End date December 2014
Trial size 30 participants
Trial identifier NCT02109406, AZD2115 D3060C00006

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
AZD 2115, Dose 1 administered as two inhalations BID
azd2115 dose 1
AZD 2115, Dose 1 administered as two inhalations BID
(Experimental)
AZD 2115, Dose 2 administered as two inhalations BID
azd 2115, dose 2
AZD 2115, Dose 2 administered as two inhalations BID
(Placebo Comparator)
Placebo MDI administered as two inhalations BID
placebo mdi
Placebo MDI administered as two inhalations BID

Primary Outcomes

Measure
Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline
time frame: 14 Days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Pearl Therapeutics, Inc..