Multicentre, Randomized, Double-blind, Parallel Group, Placebo-Controlled Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate Suspension for Inhalation 800 µg Twice Daily vs. Placebo Added to Antibiotic Therapy in Patients With Acute Rhinosinusitis
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 166
- Locations
- 3
- Primary Endpoint
- proportion of patients who will experience clinical success
Overview
Brief Summary
Intranasal corticosteroids are beneficial in the treatment of acute rhinosinusitis. As adjunctive therapy to oral antibiotic treatment, mometasone furoate at doses of 200 μg or 400 μg twice daily, was well tolerated and significantly more effective in reducing the symptoms of rhinosinusitis than antibiotic therapy alone. Furthermore,the addition of fluticasone propionate to xylometazoline and antimicrobial therapy with cefuroxime improved clinical success rates and accelerated recovery of patients with a history of chronic rhinitis or recurrent sinusitis who present for treatment of acute rhinosinusitis.
The present study was planned to assess the effects of nebulised beclomethasone dipropionate given as add-on therapy to standard care (oral antibiotics) in the treatment of acute symptomatic rhinosinusitis. Antibiotic therapy will be at the physicians' discretion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject's written informed consent obtained prior to any study-related procedures
- •Male and female out-patients aged between 18 and 65 years (inclusive).
- •History of previously diagnosed recurrent or chronic sinusitis that necessitate antibiotic therapy as judged by the investigator.
- •Clinical diagnosis of acute rhinosinusitis defined, according to the European Position Paper on Rhinosinusitis and Nasal Polyps 2007 (20), as the sudden onset of two or more relevant symptoms for \<12 weeks, at least one of which is:
- •Nasal blockage/obstruction/congestion, OR
- •Nasal discharge (anterior/posterior nasal drip);
- •AND the second one is:
- •Facial pain/pressure or/and reduction/loss of sense of smell.
- •A cooperative attitude and ability to be trained to use correctly the nebuliser with intranasal nose piece.
Exclusion Criteria
- •Previous sinus surgery;
- •Sinus lavage within the past 7 days;
- •Nasal polyposis or important nasal septum deviation;
- •Antibiotic use (by any route) in the past 30 days;
- •Recurrent moderate epistaxis;
- •Chronic bacterial sinusitis with evidence of failure of antimicrobial therapy;
- •Intranasal or systemic use of corticosteroids within the past 30 days;
- •Chronic use of corticosteroids or immunosuppressive agents;
- •Immunocompromised states;
- •Diagnosis of bronchial asthma or chronic obstructive pulmonary disease (COPD);
Arms & Interventions
beclomethasone dipropionate
beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days
Intervention: beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days (Drug)
placebo
placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days
Intervention: placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days (Drug)
Outcomes
Primary Outcomes
proportion of patients who will experience clinical success
Time Frame: 28 days
Secondary Outcomes
- overall sinus symptoms(7,14,21,28 days)
- changes of each symptom(7, 14, 21, 28 days)
- level of work performance based on patient perception (recorded on a VAS scale of the diary card) and on missed working time(7, 14 days)
- absence of relapses(7, 14, 21, 28 days)
- nasal mucociliary transport time(7, 14 days)
- nasal air flow resistance(7, 14 days)
- Adverse events and adverse drug reactions(0, 7, 14, 21, 28 days)
- vital signs(0, 7, 14, 21, 28 days)