Acute RhinosinusitisPhase 3CLEARNCT01691677
beCLomethasone Efficacy in Acute Rhinosinusitis - CLEAR Study
A Phase 3 study testing beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days in people with Acute Rhinosinusitis, run by Chiesi Farmaceutici S.p.A. at 3 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Rhinosinusitis
- What is being tested?
- beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 3 sitesItaly
- Study dates
- Jan 2013to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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);
- 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.
- Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- Participation in another trial in the past 12 weeks or patients previously enrolled in this study.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Cisanello
Pisa
Policlinico Univesitario Gemelli
Roma
Policlinico Santa Maria alle Scotte
Siena, Italy
About this study
Official title: 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
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
- Being tested
- beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days, placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 daysDrug
placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 daysDrug
| Study group | Role | What they receive |
|---|---|---|
| beclomethasone dipropionate | Experimental | beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days Receives: 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 Receives: Drug: placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who will experience clinical success
Measured: 28 days
Secondary outcomes (8)
overall sinus symptoms
Measured: 7,14,21,28 days
changes of each symptom
Measured: 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
Measured: 7, 14 days
absence of relapses
Measured: 7, 14, 21, 28 days
nasal mucociliary transport time
Measured: 7, 14 days
nasal air flow resistance
Measured: 7, 14 days
Adverse events and adverse drug reactions
Measured: 0, 7, 14, 21, 28 days
vital signs
Measured: 0, 7, 14, 21, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691677
- Sponsor's protocol ID
- MC/PR/1400/007/11
- Acronym
- CLEAR
- Status last verified
- Mar 2017
- First submitted
- 1 Aug 2012
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01691677
- Acronym / sponsor ID
- CLEAR / MC/PR/1400/007/11
- Conditions
- Acute Rhinosinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| beclomethasone dipropionate | Experimental | Drug: beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 daysbeclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days |
| placebo | Placebo comparator | Drug: placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 daysplacebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- A cooperative attitude and ability to be trained to use correctly the nebuliser with intranasal nose piece.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
proportion of patients who will experience clinical success
Time frame: 28 days
8 secondary outcomes
overall sinus symptoms
Time frame: 7,14,21,28 days
changes of each symptom
Time frame: 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
Time frame: 7, 14 days
absence of relapses
Time frame: 7, 14, 21, 28 days
nasal mucociliary transport time
Time frame: 7, 14 days
nasal air flow resistance
Time frame: 7, 14 days
Adverse events and adverse drug reactions
Time frame: 0, 7, 14, 21, 28 days
vital signs
Time frame: 0, 7, 14, 21, 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days in people with Acute Rhinosinusitis, run by Chiesi Farmaceutici S.p.A. at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients who will experience clinical success (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.