Acute rhinosinusitis MedDRA version: 14.1 Level: LLT Classification code 10052106 Term: Rhinosinusitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: CLENIL*AER 20FL 1D 0,8MG/2ML
Pharmaceutical Form: Nebuliser suspension
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Current Sponsor code: CHF718
Concentration unit
Sponsors
CHIESI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects written informed consent obtained prior to any study-related procedures 2. Male and female out-patients aged between 18 and 65 years (inclusive). 3. History of previously diagnosed recurrent or chronic sinusitis that necessitated antibiotic therapy as judged by the investigator. 4. Clinical diagnosis of acute rhinosinusitis defined, according to the European Position Paper on Rhinosinusitis and Nasal Polyps 2012 (20), as the sudden onset of two or more relevant symptoms for =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous sinus surgery; 2. Sinus lavage within the past 7 days; 3. Nasal polyposis or important nasal septum deviation; 4. Antibiotic use (by any route) in the past 30 days; 5. Recurrent moderate epistaxis; 6. Chronic bacterial sinusitis with evidence of failure of antimicrobial therapy; 7. Intranasal or systemic use of corticosteroids within the past 30 days; 8. Chronic use of corticosteroids or immunosuppressive agents; 9. Immunocompromised states; 10. Diagnosis of bronchial asthma or chronic obstructive pulmonary disease (COPD); 11. History of clinically significant cardiac (i.e. congestive heart failure or severe hypertension), renal (i.e. kidney failure), psychiatric (i.e. depression or mood disorders), hepatic (i.e. cholestatic jaundice or hepatic dysfunction), endocrine (i.e. hyperthyroidism or adrenal suppression) or pulmonary disease, or laboratory testing abnormalities, whose sequelae and/or treatments can interfere with the results or treatments of the present study; 12. History of psychiatric diseases likely to require treatment with antidepressant drugs during the study period or treatment with antidepressant drugs in the past 2 weeks; 13. Diagnosis of glaucoma or prostatic hypertrophy; 14. History of alcohol or drug abuse; 15. Allergy, sensitivity or intolerance to study drugs and/or study drugs formulations ingredients (e.g. corticosteroids ); 16. Pregnant or lactating women or all women physiologically capable of becoming pregnant 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: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy) hormonal contraception (implantable, patch, oral) double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). A pregnancy test (urine) will be performed at screening in women of childbearing potential; 17. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 18. Participation in another trial in the past 12 weeks or who patients have been previously enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that BDP suspension for inhalation twice a day for 14 days added to antibiotic therapy improves clinical success rate and accelerates recovery in patients with acute rhinosinusitis.;Secondary Objective: • To assess the time from baseline to a status of clinical success (cured or much improved); • To assess the rhinosinusitis symptoms during the treatment phase; • To assess the changes of overall sinus symptoms and tha changes of each symptoms; • To assess the level of work performance based on patient perception (recorded on a VAS scale of the diary card) and on missed working time; • To assess the number or recurrences assess the absence of relapses; • To assess the changes of nasal mucociliary transport time; • To assess the nasal air flow resistance with rhinomanometry; • To assess the safety profile of the investigational study drug.;Primary end point(s): Proportion of patients who will experience clinical success at 7, 14, 21 or 28 days. Clinical success is defined as a patient report of cured or much improved.;Timepoint(s) of evaluation of this end point: 7, 14, 21 or 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time from baseline to a status of clinical success (cured or much improved); rhinosinusitis symptoms in the treatment phases; changes of overall sinus symptoms and the changes of each symptoms; level of work performance based on patient perception (recorded on a VAS scale of the diary card) and on missed working time; absence of relapses; nasal mucociliary transport time; nasal air flow resistance.;Timepoint(s) of evaluation of this end point: 7, 14, 21 or 28 days. | — |
Countries
Italy
Contacts
Public ContactEleonora Ingrassia
Chiesi Farmaceutici
Outcome results
None listed