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

NCT02296814 | Completed Phase 4

• 3 other identifiers: SHDE-12014-000907-29DRKS00006877
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 20

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).

Conditions

Acute Rhinosinusitis

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks

• 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.

  2 weeks

Secondary Outcomes (13)

• Time to response

  2 weeks

• Change in the overall MRSSinv (main symptoms)

  2 weeks

• Change in the overall MRSSinv (remaining symptoms)

  2 weeks

• Time to disappearance

  2 weeks

• Time to improvement

  2 weeks

Study Arms (2)

Sinusitis Hevert SL Tablet

ACTIVE COMPARATOR

two weeks treatment

Drug: Sinusitis Hevert SL Tablet

Placebo for Sinusitis Hevert SL Tablet

PLACEBO COMPARATOR

two weeks treatment

Drug: Placebo for Sinusitis Hevert SL Tablet

Interventions

Sinusitis Hevert SL Tablet DRUG

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

Sinusitis Hevert SL Tablet

Placebo for Sinusitis Hevert SL Tablet DRUG

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

Placebo for Sinusitis Hevert SL Tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Women of childbearing potential: willingness to use contraception methods

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Hevert-Arzneimittel GmbH & Co. KG: lead

Study Sites (20)

Immanuel Krankenhaus Berlin

Berlin, Germany

Location

Site in Berlin

Berlin, Germany

Location

Site in Bochum

Bochum, Germany

Location

Site in Chemnitz

Chemnitz, Germany

Location

Site in Köln

Cologne, Germany

Location

Site in Dresden

Dresden, Germany

Location

Site in Duisburg

Duisburg, Germany

Location

Site in Düren

Düren, Germany

Location

Site in Essen

Essen, Germany

Location

Site in Frankfurt am Main

Frankfurt am Main, Germany

Location

Site in Gars am Inn

Gars Am Inn, Germany

Location

Site in Goch

Goch, Germany

Location

Site in Haag

Haag, Germany

Location

Site in Hamburg

Hamburg, Germany

Location

Site in Heidelberg

Heidelberg, Germany

Location

Site in Künzing

Künzing, Germany

Location

Site in Leipzig

Leipzig, Germany

Location

Site in Röthenbach

Röthenbach, Germany

Location

Site in Wiesbaden

Wiesbaden, Germany

Location

Site in Wolmirstedt

Wolmirstedt, Germany

Location

Study Officials

• Andreas Michalsen, Prof Dr

  Immanuel Krankenhaus Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: November 7, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

DE (20)