Chronic Obstructive Pulmonary Disease
Conditions
Interventions
During the run-in period of 4weeks between screening and randomisation, subjects will be asked to use Symbicort® Turbohaler® 200/6 µg/unit dose 1 inhalation b.i.d.
(daily dose of BUD 400 µg plus FF 12
2. Treatment B: Symbicort® Turbohaler® (budesonide 200 μ
g plus formoterol fumarate 6 μ
g/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μ
g plus FF 24 μ
g).
After which the treatment phase of 12 weeks will start. After 12 weeks the study stops and a short followup phase of 7-10 days is applicable.
Sponsors
CROMSOURCE – Quality System Certified ISO 9001
Lange Dreef 11H, NL-4131 NJ Vianen, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative; 2. Outpatients with a clinical diagnosis of moderate to severe COPD and including: A. Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) x (number of years of smoking)] / 20, both current and ex-smokers are eligible; B. Regular use of bronchodilators (e.g. β2-agonist, anticholinergics) in the 2 months before visit 1; C. Post-bronchodilator FEV1 120% of the predicted normal value (at visit 1 and visit 2); G. A Baseline Dyspnoea Index (BDI) focal score smaller then or equal to 10 (at visit 1 and at visit 2). 3. A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Turbohaler®, inspiratory flow-driven, multidose powder inhaler) inhalers.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of asthma or other clinically or functionally relevant respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator’s opinion; 2. Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or are using one or more of the following acceptable methods of contraception: A. Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy); B. Hormonal contraception (implantable, patch, oral, injectable); C. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository; D. Continuous abstinence (e.g. nuns); E. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation. 3. Clinically unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which may impact the evaluation of the results of the study according to investigator’s judgement; 4. Patient with narrow-angle glaucoma; 5. Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which may impact the evaluation of the results of the study and the safety of the patient according to investigator’s judgement; 6. Patients with COPD exacerbation and/or symptomatic infection of the airways requiring antibiotic therapy (at least 5 days) in the 2 months prior to screening and during the study period. COPD exacerbation will be defined according to the following: “A sustained worsening of the patient’s condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids (at least 3 days) and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization”; 7. Patients requiring long term (> 12 hours daily) oxygen therapy for chronic hypoxemia; 8. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period; 9. Patients with known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in the study drugs; 10. Patients who have evidence of alcohol or drug abuse, not compliant with the study protocol or not compliant with the study treatments according to investigator’s judgement; 11. Major surgery in the previous 3 months and during the trial which may affect patient’s compliance in study procedures (e.g. plethysmography); 12. Participation in another clinical trial with an investigational drug in the 2 months preceding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction in patients with Chronic Obstructive Pulmonary Disease. This will be proven by measuring the change from baseline to end of treatment in post-dose residual volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the test treatments in terms of reduction of symptoms, improvements in health status (assessed by specific questionnaires) and in parameters related to small airway function in patients with Chronic Obstructive Pulmonary Disease, and to assess the safety of study treatments. These will be confirmed by: 1. Changes from baseline in FEV1, FVC, FEV1/FVC, IVC/FVC, RV, TLC, RV/TLC, FRC, FRC/TLC, RV/VC, Raw, eff and sGaw, eff; 2. Changes from baseline in airways resistance (R5, R20, R5-20) and reactance at 5 Hertz (X5) (in a subset of at least 50% of patients from pre-selected sites); 3. Changes from baseline in COPD symptom scores (for each single score and the total score); 4. Change from baseline in percentage of COPD symptom-free days; 5. Change from baseline in rescue salbutamol or ipratropium bromide consumption (puffs per day); 6. Change from baseline in percentage of rescue salbutamol or ipratropium bromide-free days; 7. Transition Dyspnoea Index (TDI) score at day 84 (V4); 8. Clinical COPD Questionnaire (CCQ); 9. Physical activity (by means of pedometer); 10. Nasal brushing (mRNA expression); 11. Number of patients with COPD exacerbations. | — |
Contacts
Public ContactBerge, van de
UMCG Postbus 30 001
Outcome results
None listed