NCT01146860

Brief Summary

The purpose of this study is to determine whether the dry extract BNO 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

August 2, 2013

Completed
Last Updated

August 2, 2013

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

June 7, 2010

Results QC Date

October 9, 2012

Last Update Submit

June 28, 2013

Conditions

Acute Rhinosinusitis

Keywords

BNO 1016, acute rhinosinusitis

Outcome Measures

Primary Outcomes (1)

  • Major Symptom Score (MSS) Assessed by the Investigator

    MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure. Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe. Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points.

    14 days

Secondary Outcomes (4)

  • SNOT 20 Symptom Scores

    14 days

  • Major Symptom Score Assessed by the Patient

    14 days

  • Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale

    14 days

  • Ultrasonography of Paranasal Sinuses

    14 days

Study Arms (2)

BNO 1016

EXPERIMENTAL

sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days

Drug: BNO 1016

Placebo

PLACEBO COMPARATOR

sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days

Drug: Placebo

Interventions

BNO 1016DRUG

sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days

Also known as: Sinupret extract
BNO 1016
PlaceboDRUG

sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days

Also known as: Placebo to BNO 1016
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of acute rhinosinusitis
  • characterized by a major symptom score (MSS) ≥ 8 and ≤ 12 points (minimum 0, maximum 15 points)
  • individual score for facial pain/pressure ≥ 1 (mild) and ≤ 2 (moderate)
  • confirmed by ultrasonography of paranasal sinuses

You may not qualify if:

  • Chronic rhinosinusitis
  • Polyposis nasi
  • Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation/airflow
  • Acute symptoms of a known allergic rhinitis
  • Signs or symptoms of fulminant bacterial sinusitis
  • Odontogenic sinusitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Rainer Jund, Specialist in Otorhinolaryngology

Puchheim, 82178, Germany

Location

Related Publications (1)

  • Jund R, Mondigler M, Steindl H, Stammer H, Stierna P, Bachert C; ARhiSi II study group. Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis. Rhinology. 2012 Dec;50(4):417-26. doi: 10.4193/Rhino.12.015.

    PMID: 23193534DERIVED

MeSH Terms

Interventions

BNO 1016Sinupret

Limitations and Caveats

Headache and facial pain are rated by investigator based on the description of the patient. This was done to ensure a uniform rating of symptom severity across the investigational sites but nevertheless subjective and open to error.

Results Point of Contact

Title
Dr. Rainer Jund, Specialist in Otorhinolaryngology
Organization
ENT practice
RainerJund@gmx.de
+49 89 804880

Study Officials

  • Rainer Jund, MD

    Specialist in Otorhinolaryngology

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 22, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 2, 2013

Results First Posted

August 2, 2013

Record last verified: 2013-06

Locations

DE(1)