A multi-centre, randomised, double-blind, cross-over design study to evaluate efficacy on exercise tolerance of budesonide/formoterol (Symbicort®Turbuhaler®) 320/9 µg one inhalation twice daily compared with placebo and formoterol (Oxis®) Turbuhaler 9 µg one inhalation twice daily in patients with severe chronic obstructive pulmonary disease (COPD). - CODEX
- Conditions
- Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2006-006519-60-DE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Provision of informed consent prior to conducting any study-related procedure
2. Out-patient, man or woman =40 years of age
3. A clinical diagnosis of COPD, and symptoms for more than 2 years prior to visit 2
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 course of oral steroids
and/or antibiotics within 1-12 months before visit 2
6. FEV1=50% of predicted normal value (pre-bronchodilator)
7. FEV1/VC<70% (pre-bronchodilator)
8. FRC=120% of predicted normal value (pre-bronchdilator)
9. Wmax at least 20 watts from the incremental exercise test at visit 2
10. Ability to safely perform the maximal exercise test on cycle without medical
contraindications
11. Documented use of short-acting inhaled bronchodilator (ß2-agonists or
anticholinergics) as reliever medication
12. Able to read and write and use the electronic devices (eDiary and ePEF)
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. A history of asthma.
2. A history of seasonal allergic rhinitis before 40 years of age
3. Exacerbation of COPD during run-in or within 4 weeks (end of exacerbation)
prior to visit 2, requiring hospitalisation, a course of oral and/or inhaled steroids
and/or antibiotics
4. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart
failure, uncontrolled hypertension as defined by the investigator, or any other
relevant cardiovascular disorder as judged by the investigator
5. Regular oxygen therapy
6. Any current respiratory tract disorder other than COPD, which is considered by
the investigator to be clinically significant
7. 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 influence the
results of the study, or the patient’s ability to participate in the study
8. Signs and symptoms of peripheral arterial occlusion
9. SaO2=90% at rest
10. Any abnormality in ECG that could put patient at risk while performing exercise
testing, as judged by the investigator
11. Patient taking non-cardioselective ß-blocking agents
12. Use of inhaled corticosteroids within 2 weeks prior to visit 2 and during run-in.
13. Use of oral/parenteral corticosteriods within 4 weeks prior to visit 2 and during run-in.
14. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women
not using acceptable contraceptive measures. Acceptable contraceptive methods
are methods of birth control which result in a low failure rate (ie, less than 1 %
per year) when used constantly and correctly such as implants, combined oral
contraceptives, some intrauterine devices, sexual abstinence or vasectomised
partner
15. Known or suspected hypersensitivity to study therapy or excipients of the
investigational products
16. Scheduled in-patient hospitalisation during the course of the study
17. Patients who have participated in a clinical study evaluating an investigational
product in the last 4 weeks prior to enrolment, or during this study, or who have been previously
allocated a randomisation code in this study
18. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance
19. Patients participating in or scheduled for an intensive COPD rehabilitation program
20. 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
21. Planned donation of blood during the study
22. 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 Primary end point(s): The Primary efficacy variable will be:<br>- Exercise Endurance Time (EET) performed at 75% of Peak Work Capacity<br>(Wmax) with cycle ergometry (1 hour post dose);Secondary Objective: The secondary objective of the study is to evaluate safety by assessing the nature and incidence of AEs.<br>;Main Objective: The primary objective of this study is to compare the efficacy on exercise tolerance of<br>Symbicort Turbuhaler 320/9 microgram twice daily compared to placebo and Oxis Turbuhaler 9 microgram twice daily in patients with severe COPD by evaluation of the Exercise Endurance Time (EET) measured at 75% of Wmax with cycle ergometry 1 hour post-dose at visits 5, 7 and 9 (end of each treatment period) as the primary outcome variable.<br><br>
- Secondary Outcome Measures
Name Time Method