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

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ClinicalTrials.gov Identifier: NCT02109406
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: AZD2115 Dose 1 Drug: AZD 2115, Dose 2 Drug: Placebo MDI Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: AZD2115 Dose 1
AZD 2115, Dose 1 administered as two inhalations BID
Drug: AZD2115 Dose 1
AZD 2115, Dose 1 administered as two inhalations BID

Experimental: AZD 2115 Dose 2
AZD 2115, Dose 2 administered as two inhalations BID
Drug: AZD 2115, Dose 2
AZD 2115, Dose 2 administered as two inhalations BID

Placebo Comparator: Placebo MDI
Placebo MDI administered as two inhalations BID
Drug: Placebo MDI
Placebo MDI administered as two inhalations BID




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109406


Locations
United States, Florida
Pearl Therapeutics Study Site
Clearwater, Florida, United States
United States, South Carolina
Pearl Therapeutics Study Site
Charlotte, South Carolina, United States
Pearl Therapeutics Study Site
Spartanburg, South Carolina, United States
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Shahid Siddiqui, MD Pearl Therapeutics, Inc.

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02109406     History of Changes
Other Study ID Numbers: AZD2115 D3060C00006
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases