Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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).
Interventions
DRUGAZD2115 Dose 1
AZD 2115, Dose 1 administered as two inhalations BID
DRUGAZD 2115, Dose 2
AZD 2115, Dose 2 administered as two inhalations BID
DRUGPlacebo MDI
Placebo MDI administered as two inhalations BID
Sponsors
Pearl Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline | 14 Days |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of action | Day 1 |
| Forced vital capacity (FVC) AUC0-12 relative to baseline | 14 Days |
| Change from baseline in 12-hour post dose trough FEV1 | 14 Days |
| Change from baseline in morning pre dose trough FEV1 | 14 Days |
| Peak change in FEV1 | 14 Days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 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. |
| Pharmacokinetics | 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) |
Countries
United States
Outcome results
None listed