Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 12.0 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: Formoterol Turbuhaler
Pharmaceutical Form: Inhalation powder
CAS Number: 0
Other descriptive name: FORMOTEROL FUMARATE DIHYDRATE
Concentration unit: µg microgram(s)
Concentration type: e
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent obtained prior to conducting any study-related procedures including withdrawal of pre-study medication 2. Outpatients, female or male, = 40 years 3. A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms 4. A current or previous smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year). 5. Documented use of a short-acting inhaled bronchodilator (ß2-agonist or anticholinergics) as reliever medication. 6. FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A history and/or current diagnosis of asthma. 2. A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40. 3. A known total blood eosinophil count over 400 mm3. 4. Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 4 weeks (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period. 5. Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator. 6. Any current respiratory tract disorder other than COPD, including respiratory diseases described in GOLD guidelines as needed to be differentiated from 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 may influence the results of the study, or the patients ability to participate in the study. 8. Any clinically relevant abnormal finding in physical examination, at Visit 2 which, in the opinion of the investigator, may put the patient at risk because of participation in the study. 9. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator. 10. Known or suspected hypersensitivity to study therapy and/or excipients. 11. Scheduled in-patient hospitalisation during the course of the study. 12. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance. 13. Patients participating in or scheduled for an intensive COPD rehabilitation program. 14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at study site). 15. Previous enrolment (that failed due to inclusion/exclusion criteria and/or safety) or randomisation of treatment in the present study. 16. Participation in another clinical study evaluating an investigational drug in the last 8 weeks prior to Visit 2 or during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective: To evaluate time to onset of effect of formoterol, 9 µg single dose, compared with salmeterol, 50 µg single dose, in patients with moderate COPD.;Secondary Objective: The secondary objective: To evaluate safety. - Adverse events (nature, incidence and intensity) - Pulse rate and blood pressure ;Primary end point(s): Forced Expiratory Volume in 1 second (FEVi) measured by spirometry 5 minutes post dose. | — |
Countries
Italy, Spain, Sweden
Outcome results
None listed