Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 17.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: AZD7624 inhal. sol. 2-20 mg/mL, ADI delivery unit
Product Code: AZD7624 inhal. sol. 2-20 mg/mL, ADI delivery unit
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: NA
CAS Num
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures 2. Male and females aged 40 - 85 years 3. Females must have a negative pregnancy test at Visit 1, must not be lactating and must be of non-childbearing potential, by fulfilling one of the following criteria: ?-Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all possible exogenous hormonal treatments and luteinising hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range (at Visit 1) 6. Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the GOLD 2014 guidelines 7. Stable COPD maintenance treatment with at least ICS/LABA for at least 2 months prior to enrolment (Visit 1), to be continued unchanged during the study 8. A post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at third party vendor or at the investigational sites) 2. Previous randomisation to treatment in the present study (at Visit 1) 3. Participation in another clinical study with any novel investigational medicinal product within 3 months before the first dose of investigational product in this study (at Visit 3) 4. Previously intake of any p38 inhibitor (same class as AZD7624) 5. Participation in, or scheduled for an intensive COPD rehabilitation programme at any time during the study (N.B. patients are allowed to be in the maintenance phase of a rehabilitation programme) 6. Planned in-patient surgery or hospitalisation during the study 7. Significant disease or disorder other than COPD (e.g. cardiovascular; pulmonary as e.g. tuberculosis and cystic fibrosis; gastrointestinal, liver; neurological; musculoskeletal; endocrine; metabolic; malignant; psychiatric; major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient’s ability to participate in the study (at Visit 1) 8. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines (GINA 2013) or other accepted guidelines. Patients with a past medical history of asthma (e.g. childhood or adolescence) may be included 9. Any clinically relevant abnormal findings in clinical chemistry, haematology and urinalysis, which, in the opinion of the investigator, may put the patient at risk because of participation in the study (at Visit 2 and 3) 11. Any clinically relevant abnormal findings in physical examination, pulse or blood pressure which, in the opinion of the investigator, may put the patient at risk because of participation in the study (at Visit 1, 2 and 3) 12. Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) 13.History or family history of muscle diseases (at Visit 1) 14.Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (at Visit 1, 2 and 3): ?-Systolic blood pressure (SBP) above 150 mmHg ?-Diastolic blood pressure (DBP) above 90 mmHg ?-Pulse 100 bpm 15.Prolonged QTcF >450 ms or family history of long QT syndrome or sudden death at young age. PR(PQ) interval prolongation of clinical significance, PR(PQ) > 250 ms. Intermittent second or third degree atrioventricular (AV) block, or AV dissociation. QRS duration =120ms. Patients who are not in sinus rhythm. Patients with persistent, and /or recurrent symptomatic tachyarrhythmias, as well as patients with an implantable cardioverter-defibrillator (ICD) or a permanent pacemaker. Patients on anticoagulation treatment. 16.Unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society (CSS) class 2. History of hospitalisation within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) class II. Acute myocardial infarction within 6 months of screening (Visit 1). 17. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624 18. Any exacerbation (defined as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of AZD7624 vs. placebo on the time to first event of moderate or severe COPD exacerbation or early drop-out related to worsening of COPD symptoms (i.e. composite endpoint referred to as “ExDo”) in patients with COPD on maintenance treatment with at least ICS/LABA.;Secondary Objective: To compare the effects of AZD7624 vs. placebo as add-on to COPD maintenance treatment with at least ICS/LABA in patients with COPD on: -Number of moderate and severe COPD exacerbations and early drop-outs related to worsening of COPD symptoms -Time to first event of moderate or severe COPD exacerbations or early drop-out (including drop-outs due to any cause) -Number of moderate and severe COPD exacerbations and early drop-outs (including drop-outs due to any cause) -Time to first and number of moderate or severe exacerbations -Time to first and number of symptom defined exacerbations -Pulmonary function measured as changes from baseline in trough FEV1, FVC and FEV1/FVC -Health related quality of life -Dyspnea To evaluate the pharmacokinetic profile of AZD7624 in patients with COPD on maintenance treatment with at least ICS/LABA. To evaluate the safety and tolerability of AZD7624 vs. placebo in patients with COPD on maintenance treatment with at least ICS/LABA.;Primary end point(s): Time to first event of moderate or severe COPD exacerbation or early drop-out ;Timepoint(s) of evaluation of this end point: Throughout study treatment period (12 weeks treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of moderate to severe COPD exacerbations or early drop-outs Time to first event of moderate to severe COPD exacerbations or early drop-out (including drop-outs due to any cause) Trough FEV1, FVC and FEV1/FVC Time to first symptom defined exacerbation (as defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] daily diary) Number of and time to first symptom defined exacerbations (as defined by the EXACT daily diary) Symptoms of COPD (using the EXACT for Respiratory Symptoms [E-RS], a subset of items from the EXACT diary) Health related quality of life (as assessed by SGRQ-C) Dyspnea (as assessed by BDI/TDI score) AUC, Cmax, t1/2 ;Timepoint(s) of evaluation of this end point: Throughout study treatment period (12 weeks treatment) | — |
Countries
Argentina, Chile, Germany, Netherlands, South Africa, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed