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

NCT ID: NCT02296814

Last Updated: 2015-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-04-30

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.

Conditions

Acute Rhinosinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sinusitis Hevert SL Tablet

two weeks treatment

Group Type: ACTIVE_COMPARATOR

Sinusitis Hevert SL Tablet

Intervention Type: DRUG

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

Placebo for Sinusitis Hevert SL Tablet

two weeks treatment

Group Type: PLACEBO_COMPARATOR

Placebo for Sinusitis Hevert SL Tablet

Intervention Type: DRUG

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

Interventions

Sinusitis Hevert SL Tablet

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

Intervention Type: DRUG

Placebo for Sinusitis Hevert SL Tablet

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hevert-Arzneimittel GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Michalsen, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Immanuel Krankenhaus Berlin

Locations

Immanuel Krankenhaus Berlin

Berlin, , Germany

Site in Berlin

Berlin, , Germany

Site in Bochum

Bochum, , Germany

Site in Chemnitz

Chemnitz, , Germany

Site in Köln

Cologne, , Germany

Site in Dresden

Dresden, , Germany

Site in Duisburg

Duisburg, , Germany

Site in Düren

Düren, , Germany

Site in Essen

Essen, , Germany

Site in Frankfurt am Main

Frankfurt am Main, , Germany

Site in Gars am Inn

Gars Am Inn, , Germany

Site in Goch

Goch, , Germany

Site in Haag

Haag, , Germany

Site in Hamburg

Hamburg, , Germany

Site in Heidelberg

Heidelberg, , Germany

Site in Künzing

Künzing, , Germany

Site in Leipzig

Leipzig, , Germany

Site in Röthenbach

Röthenbach, , Germany

Site in Wiesbaden

Wiesbaden, , Germany

Site in Wolmirstedt

Wolmirstedt, , Germany

Countries

Germany

Other Identifiers

2014-000907-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRKS00006877

Identifier Type: REGISTRY

Identifier Source: secondary_id

SHDE-1

Identifier Type: -

Identifier Source: org_study_id