Clinical trial NCT02296814: Efficacy and Safety of Sinusitis Hevert SL Tablets Compared to Placebo in Adult Patients With Acute, Uncomplicated Rhinosinusitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Rhinosinusitis
Lead sponsor: Hevert-Arzneimittel GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2014-11-20
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Male and female outpatients, aged ≥ 18 and ≤ 75 years
3. 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.
4. Women of childbearing potential: willingness to use contraception methods

Exclusion Criteria:

Medical history

* Diseases

  1. Chronic rhinosinusitis (i.e. all forms and causes of persistent chronic rhinosinusitis)
  2. Polyposis nasi, recent history
  3. Infection of dental origin in the maxilla
  4. Cystic fibrosis, recent history
  5. Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / air flow
  6. Acute symptoms of a known allergic rhinitis
  7. History of smoking within the last two years prior to study enrolment or current smoking habits
  8. Patients with asthma
  9. Known hypersensitivity to study medication or excipients (asteraceae, lactose, allergy to bee venom, etc.)
  10. Underlying diseases leading to a significant immune deficiency
  11. Signs or symptoms of bacterial sinusitis requiring antibiotic treatment (e.g. fever \>38.3°C, orbital complications, severe unilateral frontal headache or toothache)
  12. 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
  13. Patients with untreated/unstable thyroid gland disorder (treatment should not include iodine supplementation)
  14. 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

  1. Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids within the last 4 weeks prior to study inclusion
  2. 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
  3. Treatment with decongestant (α-sympathomimetics on the day of study inclusion within 5 hours prior to screening and during the study)
  4. Chronic use of decongestant remedies
  5. Treatment with immunosuppressive medication 8 weeks prior to study inclusion and during the study for any condition
  6. Systemic antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to study inclusion
  7. Patients requiring antibiotic treatment for any condition at study entry
* General

  1. 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
  2. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
  3. Patients in custody by juridical or official order
  4. Patients who have difficulties in understanding the language (German) in which the patient information is given
  5. 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

Primary outcomes:
measure: Rate of responders
timeFrame: 2 weeks
measure: Rate of remissions
timeFrame: 2 weeks
Secondary outcomes:
measure: Time to response
timeFrame: 2 weeks
measure: Change in the overall MRSSinv (main symptoms)
timeFrame: 2 weeks
measure: Change in the overall MRSSinv (remaining symptoms)
timeFrame: 2 weeks
measure: Time to disappearance
timeFrame: 2 weeks
measure: Time to improvement
timeFrame: 2 weeks
measure: Time to remission
timeFrame: 2 weeks
measure: Change in the individual MRSSinv symptoms
timeFrame: 2 weeks
measure: SNOT-20 GAV
timeFrame: 2 weeks
measure: VASpat
timeFrame: 2 weeks
measure: VASinv
timeFrame: 2 weeks
measure: Change in the assessment of the patient's health status
timeFrame: 2 weeks
measure: General assessment of efficacy
timeFrame: 2 weeks
measure: Rescue medication
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Immanuel Krankenhaus Berlin
city: Berlin
country: Germany
facility: Site in Berlin
city: Bochum
country: Germany
facility: Site in Bochum
city: Chemnitz
country: Germany
facility: Site in Chemnitz
city: Dresden
country: Germany
facility: Site in Dresden
city: Duisburg
country: Germany
facility: Site in Duisburg
city: Düren
country: Germany
facility: Site in Düren
city: Essen
country: Germany
facility: Site in Essen
city: Frankfurt am Main
country: Germany
facility: Site in Frankfurt am Main
city: Gars am Inn
country: Germany
facility: Site in Gars am Inn
city: Goch
country: Germany
facility: Site in Goch
city: Haag
country: Germany
facility: Site in Haag
city: Hamburg
country: Germany
facility: Site in Hamburg
city: Heidelberg
country: Germany
facility: Site in Heidelberg
city: Köln
country: Germany
facility: Site in Köln
city: Künzing
country: Germany
facility: Site in Künzing
city: Leipzig
country: Germany
facility: Site in Leipzig
city: Röthenbach
country: Germany
facility: Site in Röthenbach
city: Wiesbaden
country: Germany
facility: Site in Wiesbaden
city: Wolmirstedt
country: Germany
facility: Site in Wolmirstedt
Study officials:
affiliation: Immanuel Krankenhaus Berlin
name: Andreas Michalsen, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: