Chronic obstructive pulmonary disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Code: AZD3199 Turbuhaler
Pharmaceutical Form: Inhalation powder
CAS Number: 925244-40-2
Current Sponsor code: AZD3199 dihydrobromide
Concentration unit: µg microgram(s)
Concentration type: equ
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study patients must fulfil the following criteria: 1. Provision of informed consent prior to any study specific procedures 2. Men or women, aged =40 years. Women must be of non-childbearing potential or must have used a highly effective contraceptive method for the last 3 months prior to Visit 1 (the start date of the run-in period). 3. Clinical diagnosis of COPD, with symptoms for more than 1 year 4. Current or ex-smokers with a smoking history of at least 10 pack years 5. 40% = FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not enter the study if any of the following exclusion criteria are fulfilled: 1. Current or a history of asthma 2. A history of atopic disease, such as allergic rhinitis, before 40 years of age 3. Any current respiratory tract disorder other than COPD, including respiratory diseases described in GOLD 2008 or JRS Guidelines 2004 as needed to be differentiated from COPD, which is considered by the investigator to be clinically significant 4. Significant disease or disorder (e.g. cardiovascular, pulmonary other than COPD, gastrointestinal, liver, renal, 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 5. Any clinically relevant abnormal findings in clinical chemistry, haematology, urinalysis, physical examination, pulse, blood pressure or ECG at Visit 1, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study 6. Body mass index (BMI) 450 ms or QT > 500 ms for both males and females) 8. A history of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, family history of Long QT syndrome) 9. Requirement for regular oxygen therapy 10. An exacerbation of COPD (defined as use of systemic antibiotics and/or systemic glucocorticosteroids and/or hospitalisation related to COPD) within 30 days of Visit 1 (the start date of the run-in period) 11. Known or suspected hypersensitivity to study therapy or excipients of the investigational product 12. Pregnancy or lactation 13. Past or present alcohol or drug abuse 14. Participation in another study involving blood donation (>500 ml) within 3 months of Visit 1 (the start date of the run-in period) 15. A suspected/manifested infection according to IATA categories A and B 16. Participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 3 months prior to Visit 1(the start date of the run-in period) 17. Planned in-patient surgery or hospitalisation during the study. 18. Previous enrolment into the present study 19. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site) For voluntary participation in the genetic part of the study: 20. Previous bone marrow transplant 21. Whole blood transfusion within 120 days of the date of genetic sample collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is: • To compare the clinical efficacy of AZD3199 inhaled once daily with 9 µg formoterol twice daily and placebo over a 4-week treatment period in adults with chronic obstructive pulmonary disease (COPD);Secondary Objective: The secondary objectives of the study are: • To investigate the safety of AZD3199 by assessment of the nature, incidence, and severity of adverse events (AE), safety laboratory variables, pulse, blood pressure, and ECG • To investigate the effect of regular treatment with AZD3199 on the reversibility in FEV1 after inhalation of salbutamol • To determine the pharmacokinetics (PK) of AZD3199 in COPD patients ;Primary end point(s): Primary outcome variable is FEV1, assessed both with regard to maximum bronchodilation and to trough effects 24 h after the morning administration • Efficacy variables are: - FEV1 - FVC - Patient reported outcomes (AZ COPD Symptom Scores, CCQ, SGRQ-C) - Use of reliever medication • Safety variables are: - Adverse Events (AE) - Safety laboratory assessments - Pulse and Blood pressure - ECG • Pharmacokinetic variables are: - Cmax and AUC0-24h post-dose (Visit 5) | — |
Countries
Bulgaria
Outcome results
None listed