Clinical trial NCT02109406: Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-09
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline
timeFrame: 14 Days
Secondary outcomes:
measure: Change from baseline in morning pre dose trough FEV1
timeFrame: 14 Days
measure: Peak change in FEV1
timeFrame: 14 Days
measure: Forced vital capacity (FVC) AUC0-12 relative to baseline
timeFrame: 14 Days
measure: Peak change in FEV1
timeFrame: Day 1
measure: Change from baseline in 12-hour post dose trough FEV1
timeFrame: 14 Days
measure: Time to onset of action
timeFrame: Day 1
Other outcomes:
measure: Pharmacokinetics
timeFrame: Day 1 through Day 15
measure: Safety
timeFrame: Day1 through Day 15
Locations:
city: Clearwater
country: United States
facility: Pearl Therapeutics Study Site
state: Florida
city: Charleston
country: United States
facility: Pearl Therapeutics Study Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pearl Therapeutics Study Site
state: South Carolina
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Shahid Siddiqui, MD
role: STUDY_DIRECTOR
References: