A 12-week, double-blind, randomised, parallel group, multi-centre, study to evaluate efficacy and safety of budesonide/formoterol (Symbicort® Turbuhaler®) 320/9 µg one inhalation twice daily on top of tiotropium (Spiriva®) 18 µg one inhalation once daily compared with tiotropium 18 µg one inhalation once daily, in patients with severe chronic obstructive pulmonary disease (COPD) - CLIMB
- Conditions
- Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2006-006796-21-SK
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 620
1. Provision of informed consent prior to conducting any study-related procedure
2. Outpatient, man or woman =40 years
3. A clinical diagnosis of COPD, and symptoms for more than 2 years
4. A current or previous smoker with a smoking history equivalent to 10 or more
pack years (1 pack year =20 cigarettes smoked per day for one year)
5. A history of at least one COPD exacerbation, requiring a dose of oral steroids
and/or antibiotics within 1 to 12 months before Visit 2
6. FEV1 =50% of predicted normal value, pre-bronchodilator
7. FEV1/VC <70%, pre-bronchodilator
8. Able to read and write and use the electronic devices (eDiary and ePEF)
To be randomised to the treatment period, the following criteria must be fulfilled at Visit 3:
9. Total COPD symptom score =2 per day for at least 7 days of the run-in period (by
totalling the breathing, cough, and chest tightness scores from the diary) or during
at least half of the run-in period if longer than 14 days
10. Complete morning recordings of PEF and GCSQ data at least 7 out of the last
10 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
1. Worsening of COPD during run-in or within 4 weeks prior to Visit 2, requiring
hospitalisation, a course of oral and/or inhaled steroids and/or antibiotics
2. Use of inhaled glucocorticosteroids within 2 weeks prior to Visit 2
3. Use of oral/parenteral glucocorticosteroids within 4 weeks prior to Visit 2
4. Any clinically relevant abnormal findings in physical examination and vital signs,
which in the opinion of the Investigator, may put the patient at risk because of
his/her participation in the study
5. A history of asthma
6. A history of seasonal allergic rhinitis before 40 years of age
7. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart
failure, renal failure, uncontrolled hypertension as defined by the Investigator, or
any other relevant cardiovascular disorder as judged by the Investigator
8. Regular oxygen therapy
9. Any current respiratory tract disorder other than COPD, which is considered by
the Investigator to be clinically significant
10. Any significant disease or disorder which, in the opinion of the Investigator, may
either put the patient at risk because of participation in the study, or may influence
the results of the study, or the patient’s ability to participate in the study
11. Patients with clinically significant narrow-angle glaucoma, significant prostatic
hyperplasia or bladder-neck obstruction in whom treatment with tiotropium may
be related to worsening of signs and symptoms related to these conditions, as
judged by the Investigator
12. Patients taking non-cardioselective ß-blocking agents
13. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women
not using acceptable contraceptive measures, as judged by the Investigator
14. Known or suspected hypersensitivity to study therapy or excipients of the study
drugs, including atropine or its derivatives, and ipratropium and any component of
this product, as judged by the Investigator
15. Scheduled in-patient hospitalization during the course of the study
16. Patients who have participated in a clinical study evaluating an investigational
drug in the last 4 weeks prior to enrolment, or who have been previously allocated
a randomisation code in this study
17. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance
18. Patients participating in or scheduled for an intensive COPD rehabilitation program
19. Planned donation of blood during the study
20. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
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