A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236 as an Oral Tablet in Patients with Moderate to Severe COPD.
- 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
- EUCTR2008-002230-30-SK
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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 30 to 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 eCRF instructions)
7. Patients that are able to discontinue non-allowed concomitant medication
8. Recent or current use of short-acting rescue/reliever medication.
For inclusion in the study at Visit 3 the patients must fulfil the following criterion:
1. A score = 1 on Breathlessness score on at least half of the numbers of days during
the run-in period. (At least 6 days with a score = 1 on 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 disorder other than COPD, which is 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 mmin 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 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. Patients with glomerular filtration rate less than 30 mL/min, calculated as
creatinine clearance from serum-creatinine according to the Cockcroft and Gault
f o rm ula: (C Lcre atinine (ml/min)= constant x (140-a g e) x w eight (kg)/se rum
creatinine (µM). Constant being 1.23 for men and 1.04 for women
8. Known HIV infection, or patients who belong to a high risk group for 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 (treatment with oral or parenteral antibiotics and/or oral
or parenteral glucocorticosteroids (GCS) and/or hospitalization related to COPD)
within 30 days of Visit 2, or during the run-in period
13. Use of oral or parenteral glucocorticosteroids within 30 days prior to Visit 2, or
during the run-in period
14. Known or suspected hypersensitivity to study therapy or excipients of the
investigational product
15. History of, or, current alcohol or drug abuse, as judged by the investigator
16. Scheduled in-patient hospitalization during the course of the study
17. Donation of blood within 3 months prior to Visit 2
18. Vaccination within 2 weeks prior to Visit 2
19. Previous randomisation of treatment in the present study
20. Participation in another clinical study involving drug administration during the last
3 months before Visit 2
21. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site)
22. 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:
23. Whole blood transfusion within 120 days of the date of genetic sample collection
24. Previous bone marrow transplant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the tolerability and safety of AZD1236, as an oral tablet, in COPD patients by assessment of:<br>incidence and nature of adverse events<br>vital signs and laboratory safety assessments;Secondary Objective: To assess the effects of AZD1236 compared with placebo on lung function, COPD symptoms, functional capacity, the BODE index, selected biomarkers in urine and blood and systemic exposure of AZD1236.;Primary end point(s): Safety<br>Adverse events, blood pressure, pulse, electrocardiogram and laboratory<br>safety variables (clinical chemistry, haematology, urinalysis).
- Secondary Outcome Measures
Name Time Method