A 4 week double-blind, placebo-controlled, randomized, parallel group phase IIa study to assess the efficacy and safety of AZD1981 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedure
2. Men, or women = 40 years of age. Women must be either surgically sterilised or
post-menopausal ie amenorrhoeic for 12 months and follicle-stimulating hormone
(FSH) plasma concentration is within the postmenopausal range as defined by
the central laboratory
3. Clinical diagnosis of COPD, with symptoms for more than 1 year before visit 1b
4. BMI between 18 and 30 kg/m2 and a minimum weight of 50 kg
5. Current or ex-smokers with a smoking history of at least 10 pack years
6. FEV1 30-80% of the predicted normal value post-bronchdilator
7. FEV1/FVC<70% post-bronchodilator
8. Use of ß2-agonist and/or anticholinergics as reliever medication within 1 year of
visit 1a.
For randomization in the study at visit 2 the patients must also fulfil the following criteria:
9. A score =1 on breathing score on at least half of the days of the run-in period.
10. A score =2 on sputum score on at least half of the days of the run-in period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any of the following is regarded as a criterion for exclusion from the study:
1. Any clinically relevant disease or disorder (past or present), including HIV or
Hepatitis B or C infection, 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
2. Any current respiratory disorder other than COPD, which is considered by the
investigator to be clinically significant or may influence the result of the study
3. History of or current clinically relevant arrhythmia, heart block, intraventricular
conduction delay or other clinically relevant ECG abnormalities, or unstable
angina, NYHA Class III-IV heart failure, as judged by the investigator
4. Malignancy or neoplastic disease within the past 5 years, other than treated
basal/squamous skin cancer or treated cervical cancer in situ
5. Disease history suggesting reduced or abnormal immune function
6. Any clinically relevant abnormal findings in physical examination, clinical
chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in
the opinion of the investigator, may put the patient at risk because of his/her
participation in the study
7. Requirement for long term oxygen therapy
8. An exacerbation of COPD within 30 days of visit 1b
9. Use of oral or systemic GCS within 30 days prior to visit 1b, or during the run-in
period
10. Known or suspected hypersensitivity to study therapy or excipients of the
investigational product
11. History of or current alcohol abuse or drug abuse, as judged by the investigator
12. Clinical judgement by the investigator that the patient is not suitable to participate in the study.
13. Participation in another study involving study drug administration within 3 months
of visit 1b, or within 1 month of visit 1b if the study did not involve study drug
administration
14. Blood donation (>500 ml) within 3 months of visit 1b
15. Scheduled inpatient hospitalisation during the study
16. Involvement in the planning and conduct of the study
17. Previous randomization of treatment in the present study
For randomization in the study at visit 2 the patients cannot fulfil the following criterion:
18. Use of any non-allowed medication during the run in period.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Dynebio

Updated 2/7/2022

A 4 week double-blind, placebo-controlled, randomized, parallel group phase IIa study to assess the efficacy and safety of AZD1981 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Recruitment & Eligibility

Study & Design

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