Chronic obstructive pulmonary disease (COPD) MedDRA version: 14.1 Level: LLT Classification code 10029977 Term: Obstructive chronic bronchitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: FOSTER*INAL 120D 100/6MCG
Pharmaceutical Form: Pressurised inhalation
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Concentration unit: µg microgram(s)
Concentratio
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patient is male or female, at least 40 years of age and no more than 85 years. - Patient has mild, moderate or severe COPD (stage I-III) according to the GOLD guidelines with a FEV1/FVC 30% of the predicted value. Diagnosis of COPD will be based on GOLD guideline criteria (16). - Reversibility to short-acting beta-agonists (SABA) (400 ?g equivalent of salbutamol) of less than 200 ml or less than 12% predicted value FEV1. - Patients will be on a constant dose of ICS/LABA (ICS: 1000 ?g/day of fluticasone or equivalent) for at least 8 weeks before study enrolment. - No acute exacerbations in the previous 3 months. - No history of systemic disease or other pulmonary disease. - No treatment with systemic glucocorticoids in the previous 4 weeks. - No history of asthma or atopic disease. - Current treatment for COPD can include SABA alone as needed or long-acting antimuscarinic drugs on regular basis. - Apart from COPD, subjects are in good psycho-physical conditions based on history, physical examimantion and laboratory tests, and are able to complete the study. - Ability to perform reproducible spirometry. - Patient is a nonsmoker and has stopped smoking for at least one year. - Ability of patient to provide informed consent, as evidenced by signing a copy of the consent form approved by the institutional review board of the subject’s respective study institution. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1. Patient is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material. 2. Patient is hospitalized. 3. Patient has undergone any major surgical procedure in the previous four weeks. 4. Patient has participated in a clinical trial involving an investigational or marketed drug in the previous four weeks. 5. Subjects who were current smokers in the previous year. Pulmonary 5. Patient has, in addition to COPD, any active, acute or chronic pulmonary disorder documented by history or physical examination. 6. Patient has history of asthma and/or reversibility to short-acting beta-agonists (SABA) (400 ?g equivalent of salbutamol) ? 200 ml or ? 12% predicted value FEV1. 7. Patient has ever been intubated for COPD, has required acute COPD therapy treated in an emergency room/urgent care facility/office setting within one month or has been hospitalized for COPD in the previous three months or required 2 or more hospitalizations for COPD in the past year. 8. Patient had an upper respiratory tract infection (URI) in the previous three weeks. General Medical 4. Patient is hypersensitive to inhaled ?-agonists or their components. 5. Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or haematological systems, or has uncontrolled hypertension (>160/95), or an immunodeficiency, or an autoimmune disorder. 6. Patient has a history of any illness that could be immediately life threatening (ventricular arrhythmia, neoplasia, incompletely cured or treated in the last three months, 'brittle' diabetes mellitus), or would pose restriction on participation in the study. Medications 2. Patient has taken the following medications: 5) Oral, intravenous, intramuscular, intra-articular corticosteroids in the previous 4 weeks with the exception of nasal or inhaled corticosteroids administered on a continuous basis. 6) Antibiotics for ?7 consecutive days in the previous 4 weeks. 7) IV gammaglobulin or immunosuppressants in the previous 4 weeks. 8) Beta-receptor-blocking agents (including ocular preparations) in individuals known to be sensitive to these compounds in the previous two weeks. Procedural 3. Patient is unable to perform acceptable, reproducible spirometry, and peak flow measurements. 4. Patient is unable or unwilling to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify breathprints of volatile organic compounds (VOC) which are associated with interruption of inhaled steroid therapy and, possibly, loss of COPD control (deterioration in symptoms and lung function, exacerbations).;Secondary Objective: To investigate the effects of treatment with a combination of inhaled beclomethasone dipropionate and formoterol (Foster?) on breath VOC profiles in patients with stable COPD; to investigate the effects of treatment and interruption of inhaled beclomethasone dipropionate/formoterol (Foster?) on lung inflammation and oxidative stress in patients with stable COPD as reflected by neutrophil, macrophage, eosinophil and lymphocyte cell counts in sputum, profiles of metabolites in EBC measured by NMR spectroscopy, concentrations of PGE2 and 8-isoprostane in EBC, concentrations of LTB4, PGE2, 8-isoprostane, and cytokines (IL-8, TNF-?, IL-1?) in sputum supernatants, urinary concentrations of 8-isoprostane, and concentrations of fraction of exhaled nitric oxide (FENO;Primary end point(s): . Response of electronic nose after steroid-withdrawal (sensor 19) (post-withdrawal visit compared with baseline visit);Timepoint(s) of evaluation of this end point: 4 and 8 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-points: 1. Response of electronic nose after re-introduction of steroid treatment (sensor 19) (post-treatment visit compared with post-withdrawal visit) 2. Neutrophil cell counts in sputum after steroid-withdrawal and treatment 3. Macrophage cell counts in sputum after steroid-withdrawal and treatment 4. Eosinophil cell counts in sputum after steroid-withdrawal and treatment 5. Lymphocyte cell counts in sputum after steroid-withdrawal and treatment 6. Profiles of metabolites in EBC after steroid-withdrawal and treatment 7. LTB4 concentrations in sputum supernatants after steroid-withdrawal and treatment 8. PGE2 concentrations in sputum after steroid-withdrawal and treatment 9. 8-Isoprostane concentrations in sputum after steroid-withdrawal and treatment 10. IL-8 concentrations in sputum supernatants after steroid-withdrawal and treatment 11. TNF-? concentrations in sputum supernatants after steroid-withdrawal and treatment 12. IL-1? concentrations in sputum supernatants after steroid-withdrawal and treatment 13. PGE2 concentrations in EBC after steroid-withdrawal and treatment 14. 8-Isoprostane concentrations in EBC after steroid-withdrawal and treatment 15. 8-Isoprostane concentrations in urine after steroid-withdrawal and treatment 16. FENO concentrations after steroid-withdrawal and treatment 17. FEV1 (forced expiratory volume in one second) after steroid-withdrawal and treatment 18. FVC (forced vital capacity) after steroid-withdrawal and treatment 19. FEV1/FVC after steroid-withdrawal and treatment 20. PEF (peak expiratory flow) after steroid-withdrawal and treatment 21. FEF25%-75% (forced expiratory flow at 25%-75% of forced vital capacity) after steroid- withdrawal and treatment 22. St. George’s Respiratory Questionnaire (SGRQ) score after steroid-withdrawal and treatment Safety endpoints 1. COPD exacerbation rate (d | — |
Countries
Italy
Contacts
Public ContactUnita' operativa di farmacologia
Policlinico Gemelli
Outcome results
None listed