A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Multi-Centre Phase IIa Study to Assess the Effects on Biomarkers in Induced Sputum, Blood and Urine of AZD1236 Administered as Oral Tablet in Moderate to Severe COPD Patients During a 6 Week Treatment Period.
- Conditions
- Chronic Obstructive Pulmonary Disease (study conducted in men or women, not of child bearing potential, aged 40 years or above).MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2008-002151-25-DK
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1. Provision of informed consent prior to any study specific procedures
2. Men, or postmenopausal/hysterectomised/oophorectomised women = 40 years of
age. Postmenopausal women defined as being amenorrhoeic for at least 24 months.
3. A minimum weight of 50 kg
4. Diagnosis of COPD for at least 1 month.
5. FEV1 40-80% of the predicted normal value (post bronchodilator) and
post-bronchodilator FEV1/FVC<70%
6. Current or ex-smokers with a smoking history of at least 10 pack years (1 pack
year = 20 cigarettes smoked per day for one year. For cigars, cigarillos etc see
further information in the eCRF instructions)
7. Patients that are able to discontinue all non-allowed concomitant medication
8. Recent or current use of short acting rescue/reliever medication
9. Be able to comply with induced sputum procedure and produce sputum.
Randomisation inclusion criteria at Visit 3
1. A score = 1 on the breathlessness score on at least half of the numbers of days (at least 6 days with a score = 1 on the breathlessness score are needed).
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
1. Any clinically relevant disease or disorder (past or present), 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 tract disorders other than COPD, which are considered by
the investigator to be clinically significant or may influence the result of the study
3. A clinical suspicion of active or latent tuberculosis defined as any of the following:
a) positive tuberculosis test (such as Quantiferon GOLD or Mantoux-test,
>5 mm in unvaccinated individuals and >10 mm in individuals with previous
BCG-vaccination),
and/or
b) suspicion of active or latent tuberculosis on chest X-ray taken within last 12
months.
and/or
c) past medical history of tuberculosis
4. Malignancy or neoplastic disease within the last 5 years, other than treated basal
squamous cell skin cancer or treated cervical cancer in situ
5. Disease history suggesting reduced or abnormal immune function
6. Any clinically relevant abnormal finding 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. Patients with glomerular filtration rate less than 60 ml/min, calculated as creatinine
clearance from serum-creatinine according to the Cockcroft and Gault formula:
(CLcreatinine (mL/min)=constant x (140-age) x weight (kg)/serum creatinine (µM).
Constant be ing 1.23 for me n and 1.04 for women
8. Known HIV infection, or patient who belong to high risk group of HIV
9. Increased Cardiac Troponin I>Upper Limit of Normal (ULN) at Visit 2
10. Patients with underlying musculoskeletal symptoms of unknown origin and
patients with shoulder girdle musculoskeletal symptoms or Dupuytrens contracture
symptoms as judged by the investigator
11. Requirement for regular oxygen therapy
12. An exacerbation of COPD (use of oral or parenteral antibiotics and/or oral or
parenteral glucocorticosteroids and/or hospitalisation related to COPD) within 30
days of Visit 2 or during run-in
13. Use of oral or parenteral glucocorticosteroids within 30 days prior to Visit 2, or
during the run-in period
14. Use of inhaled glucocorticosteroids within 14 days prior to Visit 2 or during the
run-in period
15. Known or suspected hypersensitivity to study therapy or excipients of the
investigational product
16. History of, or current alcohol abuse or drug abuse, as judged by the investigator
17. Scheduled in-patient hospitalisation during the course of the study
18. Donation of blood within 3 months prior to Visit 2
19. Vaccination within 2 weeks prior to Visit 2
20. Previous randomisation of treatment in the present study
21. Participation in another study involving drug administration within 3 months
of Visit 2
22. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site)
23. Clinical judgement by the investigator that the patient should not participate in
the study
If the patient participates in the genetic part of the study these exclusion criteria apply as well:
24. Whole blood transfusion within 120 days of the date of genetic sample collection
25. Previous bone marrow transplant.
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