beCLomethasone Efficacy in Acute Rhinosinusitis - CLEAR Study

NCT01691677 | Completed Phase 3

• 1 other identifier: MC/PR/1400/007/11
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• proportion of patients who will experience clinical success

  28 days

Secondary Outcomes (8)

• 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

Study Arms (2)

beclomethasone dipropionate

EXPERIMENTAL

beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days

Drug: beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days

placebo

PLACEBO COMPARATOR

placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days

Drug: placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days

Interventions

beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days DRUG

beclomethasone dipropionate

placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;
• 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;
• Diagnosis of glaucoma or prostatic hypertrophy;
• History of alcohol or drug abuse;
• Allergy, sensitivity or intolerance to study drugs and/or study drugs formulations ingredients (e.g. corticosteroids);

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (3)

Policlinico Santa Maria alle Scotte

Siena, Italy, Italy

Location

Ospedale Cisanello

Pisa, Italy

Location

Policlinico Univesitario Gemelli

Roma, Italy

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Interventions

Beclomethasone; Suspensions

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: September 25, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

IT (3)