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Acute RhinosinusitisPhase 4CESARNCT02296814

Efficacy and Safety of Sinusitis Hevert SL Tablets Compared to Placebo in Adult Patients With Acute, Uncomplicated Rhinosinusitis

A Phase 4 study testing Sinusitis Hevert SL Tablet in people with Acute Rhinosinusitis, run by Hevert-Arzneimittel GmbH & Co. KG at 20 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study to verify the efficacy and tolerability of Sinusitis Hevert SL tablets compared to placebo in adult patients with acute, uncomplicated rhinosinusitis (inflammation of the nasal and paranasal sinuses). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Rhinosinusitis
What is being tested?
Sinusitis Hevert SL Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
314 participants
Where
20 sitesGermany
Study dates
Nov 2014to Apr 2015
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Male and female outpatients, aged ≥ 18 and ≤ 75 years
  • Diagnosis of acute, uncomplicated (or recurrent acute) rhinosinusitis
  • characterized by Major Rhinosinusitis Symptom Score (MRSSinv) ≥ 8 and ≤ 15 points
  • individual score for facial pain/pressure (on bending) ≥ 1 (mild) and ≤ 2 (moderate)
  • with presence of symptoms ≤ 3 days prior to inclusion Out of the 5 main rhinosinusitis symptoms, at least 3 must be present. Among these, the presence of nasal congestion and facial pain / pressure (on bending) is mandatory.
  • Women of childbearing potential: willingness to use contraception methods

Who cannot join

  • Medical history
  • Diseases
  • Chronic rhinosinusitis (i.e. all forms and causes of persistent chronic rhinosinusitis)
  • Polyposis nasi, recent history
  • Infection of dental origin in the maxilla
  • Cystic fibrosis, recent history
Show all 34Show fewer
  • Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / air flow
  • Acute symptoms of a known allergic rhinitis
  • History of smoking within the last two years prior to study enrolment or current smoking habits
  • Patients with asthma
  • Known hypersensitivity to study medication or excipients (asteraceae, lactose, allergy to bee venom, etc.)
  • Underlying diseases leading to a significant immune deficiency
  • Signs or symptoms of bacterial sinusitis requiring antibiotic treatment (e.g. fever >38.3°C, orbital complications, severe unilateral frontal headache or toothache)
  • Patients with progressive auto-immune diseases, tuberculosis, leukemia or leukemia-like diseases, multiple sclerosis, inflammatory diseases of the connective tissues, rheumatoid arthritis, Lupus erythematodes, HIV infection or other chronic viral diseases
  • Patients with untreated/unstable thyroid gland disorder (treatment should not include iodine supplementation)
  • Pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who:
  • are nursing or pregnant,
  • or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier methods, sexual abstinence and vasectomised partner.
  • 15. Severe diseases of liver or kidney 16. Severe somatopathic, neurological and / or psychiatric diseases 17. Patients with malignant growth processes or cancer treatment within the last two years prior to study inclusion.
  • 18. History of alcohol or drug abuse
  • Medication
  • Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids within the last 4 weeks prior to study inclusion
  • Treatment with alternative medicine preparations (homeopathic and phytotherapeutical drugs) for treatment of common cold like symptoms or with immunomodulating properties (such as Echinacea), within the last 7 days prior to study inclusion
  • Treatment with decongestant (α-sympathomimetics on the day of study inclusion within 5 hours prior to screening and during the study)
  • Chronic use of decongestant remedies
  • Treatment with immunosuppressive medication 8 weeks prior to study inclusion and during the study for any condition
  • Systemic antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to study inclusion
  • Patients requiring antibiotic treatment for any condition at study entry
  • General
  • Parallel participation in any other clinical study or participation in another study within less than 6 weeks prior to study inclusion, or previous participation in this same study
  • Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
  • Patients in custody by juridical or official order
  • Patients who have difficulties in understanding the language (German) in which the patient information is given
  • Patients who are employees of a trial center, the CRO, the sponsor or its authorised representatives or are relatives either of the study site staff, the CRO staff; the sponsor staff or its authorised representatives

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Germany20 sites

  • Immanuel Krankenhaus Berlin

    Berlin

  • Site in Berlin

    Berlin

  • Site in Bochum

    Bochum

  • Site in Chemnitz

    Chemnitz

  • Site in Köln

    Cologne

  • Site in Dresden

    Dresden

  • Site in Duisburg

    Duisburg

  • Site in Düren

    Düren

  • Site in Essen

    Essen

  • Site in Frankfurt am Main

    Frankfurt am Main

  • Site in Gars am Inn

    Gars Am Inn

  • Site in Goch

    Goch

  • Site in Haag

    Haag

  • Site in Hamburg

    Hamburg

  • Site in Heidelberg

    Heidelberg

  • Site in Künzing

    Künzing

  • Site in Leipzig

    Leipzig

  • Site in Röthenbach

    Röthenbach

  • Site in Wiesbaden

    Wiesbaden

  • Site in Wolmirstedt

    Wolmirstedt

Other trials in Germany

About this study

Official title: Efficacy and Safety of Sinusitis Hevert SL Tablets Compared to Placebo in Adult Patients With Acute, Uncomplicated Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase IV Study (Sinusitis Study)

Study to verify the efficacy and tolerability of Sinusitis Hevert SL tablets compared to placebo in adult patients with acute, uncomplicated rhinosinusitis (inflammation of the nasal and paranasal sinuses).

Read the detailed description

Acute rhinosinusitis is one of the most common diseases worldwide with a prevalence of 6-15% and a large impact on quality of life and socioeconomics. The majority of infections are of viral origin, while acute bacterial infection occurs in only 0.5-2% of cases. Currently available treatment includes a variety of remedies, like analgesic, inhalation with water steam of diluted drugs, nasal douche or spray, decongestant and mucolytic remedies as well as antibiotics.

Sinusitis Hevert SL is registered since 2003 for the treatment of inflammation of the nose and throat region and the sinuses (sinusitis) and contains eleven homeopathic single substances which are classically used in homeopathy for this condition, but has not been evaluated in a randomized controlled clinical trial. In this multicenter, randomized, double-blind, placebo-controlled, parallel group phase IV study the efficacy and safety of Sinusitis Hevert SL tablets compared to placebo in adult patients with acute, uncomplicated rhinosinusitis shall be demonstrated.

Being tested
Sinusitis Hevert SL Tablet, Placebo for Sinusitis Hevert SL Tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sinusitis Hevert SL TabletDrug

    1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets

  • Placebo for Sinusitis Hevert SL TabletDrug

    1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets

Study groups in NCT02296814
Study groupRoleWhat they receive
Sinusitis Hevert SL TabletActive comparatortwo weeks treatment
Receives: Drug: Sinusitis Hevert SL Tablet
Placebo for Sinusitis Hevert SL TabletPlacebo comparatortwo weeks treatment
Receives: Drug: Placebo for Sinusitis Hevert SL Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of responders

    Rate of responders which occur between baseline and 14 days after baseline (V4). A response is defined as stable reduction of MRSSpat (sum of 5 main rhinosinusitis symptoms daily assessed by the patient) by at least 50%, i.e. reduction by at least 50% and no subsequent change from baseline ≥ 50% up to treatment termination.

    Measured: 2 weeks

  2. Rate of remissions

    Rate of remissions which occur between baseline and V4. A remission is defined as complete disappearance of all 5 main rhinosinusitis symptoms with no subsequent reoccurrence of any symptom up to treatment termination.

    Measured: 2 weeks

Secondary outcomes (13)

  1. Time to response

    1. Time to response

    Measured: 2 weeks

  2. Change in the overall MRSSinv (main symptoms)

    Change in the overall MRSSinv (sum of 5 main rhinosinusitis symptoms, assessed by the Investigator) at V2 (7 days after baseline), V3 (10 days after baseline) and V4 (14 days after baseline), as well as in the time course of the study

    Measured: 2 weeks

  3. Change in the overall MRSSinv (remaining symptoms)

    Change in the overall MRSSinv (sum of the remaining symptoms, assessed by the Investigator) at V2, V3 and V4, as well as in the time course of the study

    Measured: 2 weeks

  4. Time to disappearance

    Time to disappearance in the individual MRSSpat symptoms (in case of positive baseline value)

    Measured: 2 weeks

  5. Time to improvement

    Time to improvement in the individual MRSSpat symptoms (in case of positive baseline value)

    Measured: 2 weeks

  6. Time to remission

    Time to remission

    Measured: 2 weeks

  7. Change in the individual MRSSinv symptoms

    Change in the individual MRSSinv symptoms, assessed by the Investigator, between baseline and V2, V3 and V4, as well as in the time course of the study

    Measured: 2 weeks

  8. SNOT-20 GAV

    1. Change in the Sino-Nasal Outcome Test, German Adapted Version (SNOT-20 GAV), in the Overall Score (OS) as well as in the sub scores PNS (Primary Nasal Symptoms), SRS (Secondary Rhinogenous Symptoms, and Quality of Life Score (GQOL), assessed by the patient between baseline and V2, V3 and V4
    2. Change in the SNOT-20 GAV, score of 5 most important symptoms, assessed by the patient between baseline and V2, V3 and V4
    3. Change in the SNOT-20 GAV, individual symptoms, assessed by the patient between baseline and V2, V3 and V4, respectively

    Measured: 2 weeks

  9. VASpat

    Change in the assessment of health status by patient using a Visual Analogue Scale (VASpat) using a 10-cm scale (0= best state of health to 10= worst state of health) between baseline and V2, V3 and V4

    Measured: 2 weeks

  10. VASinv

    Change in the assessment of the patient's health status by the investigator using a Visual Analogue Scale (VASinv) between baseline and V4

    Measured: 2 weeks

  11. Change in the assessment of the patient's health status

    Change in the assessment of the patient's health status by the investigator using a Visual Analogue Scale (VASinv) between baseline and V4

    Measured: 2 weeks

  12. General assessment of efficacy

    General assessment of efficacy by the investigator (on a 4-point rating scale) at each visit from V2 to V4

    Measured: 2 weeks

  13. Rescue medication

    Use of antibiotics / allowed rescue medication

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02296814
Sponsor's protocol ID
SHDE-1
Other IDs
2014-000907-29, DRKS00006877, 2014
Acronym
CESAR
Status last verified
Jul 2015
First submitted
7 Nov 2014
Last updated
17 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sinusitis Hevert SL Tablet in people with Acute Rhinosinusitis, run by Hevert-Arzneimittel GmbH & Co. KG at 20 sites in Germany.

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 7 inclusion and 34 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 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Rate of responders (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02296814.

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 17 Jul 2015.

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