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Completed

NCT Number: NCT02109406

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

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).

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pearl Therapeutics Study Site, Clearwater, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD2115 Dose 1

Drug

AZD 2115, Dose 1 administered as two inhalations BID

AZD 2115, Dose 2

Drug

AZD 2115, Dose 2 administered as two inhalations BID

Placebo MDI

Drug

Placebo MDI administered as two inhalations BID

Primary outcomes

  1. 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

  1. Change from baseline in morning pre dose trough FEV1

    Time frame: 14 Days

  2. Peak change in FEV1

    Time frame: 14 Days

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

    Time frame: 14 Days

  4. Peak change in FEV1

    Time frame: Day 1

  5. Change from baseline in 12-hour post dose trough FEV1

    Time frame: 14 Days

  6. Time to onset of action

    Time frame: Day 1

Other outcomes

  1. Pharmacokinetics

    Time frame: Day 1 through Day 15

    Cmax, AUC0-12, AUC0-t, tmax, Apparent elimination half-life (t1/2), Apparent volume of distribution (Vd/F), Apparent total body clearance (CL/F)

  2. Safety

    Time frame: Day1 through Day 15

    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.

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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