This is an application for a phase III study to be conducted in COPD patients. Classification code 10010952
Conditions
Interventions
Trade Name: Symbicort pMDI 160/4.5mcg/actuation
Product Name: Symbicort pMDI 160/4.5mcg
Product Code: N/A
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: budesonide
CAS Nu
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients of either gender ³ 40 years of age. 2. Clinical diagnosis of COPD, with COPD symptoms for more than 2 years (COPD diagnosis according to GOLD guideline). 3. Smoking, current or previous with a smoking history ³ 10 pack years. 4. Pre-bronchodilatory FEV1 30-70% of predicted normal value. 5. Pre-bronchodilatory FEV1/VC £70 % 6. Reversibility, 9-25% of predicted normal FEV1 value. 7. Ability to use pressurised metered dose inhaler correctly. 8. Signed written informed consent from the patient. 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
Exclusion criteria
Exclusion criteria: 1. A history of asthma. 2. Allergic rhinitis with symptoms within the last 20 years. 3. 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. 4. Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant. 5. Any significant disease or disorder (e.g. pulmonary other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) 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. 6. Exacerbation of COPD within 30 days prior to Visit 1 and/or during run-in requiring hospitalisation, a course of antibiotics and/or oral steroids, and/or increased doses of inhaled steroids and/or parenteral treatment and/or nebulized treatment. 7. A requirement for regular use of oxygen therapy. 8. Use/need of b-blocking agents. 9. Scheduled in-patient hospitalisation during the course of the study. 10. Participation in or scheduled for an intensive COPD rehabilitation program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy i.e. to study the bronchodilatating effect within the first 180 minutes after two inhalations of Symbicort 160/4.5µg compared with two inhalations of Seretide 25/250µg, two inhalations of Ventoline 100µg, and placebo, delivered by pressurised metered dose inhalers, in patients with chronic obstructive pulmonary disease (COPD). ;Secondary Objective: - To study efficacy of two inhalations of Symbicort 160/4.5µg compared with two inhalations of Seretide 25/250µg, two inhalations of Ventoline 100µg, and placebo, by the Perception of Onset of Effect questionnaire (POE) and inspiratory capacity. - To investigate safety of two inhalations of Symbicort 160/4.5µg compared with two inhalations of Seretide 25/250µg, two inhalations of Ventoline 100µg, and placebo, by assessing the nature, incidence and severity of adverse events (AEs). ;Primary end point(s): Change in forced expiratory volume in one second (FEV1), 5 minutes after dose. | — |
Countries
Hungary
Outcome results
None listed