Acute, non-purulent rhinosinusitis MedDRA version: 19.1 Level: LLT Classification code 10052106 Term: Rhinosinusitis System Organ Class: 100000004862
Conditions
Interventions
Product Name: Cineole 200 mg, Sinupan forte
Pharmaceutical Form: Gastro-resistant capsule, soft
INN or Proposed INN: 1,8-cineole
CAS Number: 470-82-6
Other descriptive name: CINEOLE
Concentration unit
Sponsors
Engelhard Arzneimittel GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who are able to understand and are willing to comply to trial instructions. 2) Having given written informed consent. 3) Age 18 to 75 years (inclusively). 4) Diagnosis of acute non-purulent rhinosinusitis with an appearance of sinusitis symptoms = 5 days confirmed by ultrasonography of paranasal sinuses. 5) Baseline investigator-evaluated major symptom score (MSS) of =8 and =12 (of maximal 15 score points), out of the 5 main rhinosinusitis symptoms at least 3 must be present. Among these the presence of nasal congestion and facial pain / pressure is mandatory. 6) Presence of nasal congestion (score of = 1 on four-point rating scale). 7) Mild to moderate facial pain/pressure (score of = 1 and = 2 on four-point rating scale). 8) Satisfactory health condition except for the rhinosinusitis as determined by the investigator based on medical history and physical examination. 9) No clinical assumption of necessity for antibiotic indication or application within 3 days before treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 235 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1) Clinical assumption of necessity for antibiotic indication or application within 3 days before treatment. 2) History of hypersensitivity to any excipient of the applied drugs. 3) Concomitant treatment with antibiotics, decongestal nasal sprays, antacida and proton-pump inhibitors, secretolytic agents other than the trial medication or any other medication or treatment listed in the disallowed medication list. 4) Acute exacerbation of allergic or chronic rhinosinusitis within 30 days. 5) Surgery of paranasal sinuses within 6 weeks. 6) Polyposis nasi, Cystic fibrosis and anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / airflow. 7) Patients with bronchial asthma. 8) Underlying diseases leading to significant immune deficiency. 9) Signs or symptoms of fulminant bacterial sinusitis (e.g. fever > 38.5 °C, orbital complications, severe unilateral frontal headache or toothache). 10) Odontogenic sinusitis. 11) Drug or alcohol abuse in the opinion of the investigator. 12) Participation in a clinical trial within 30 days prior to the treatment phase of this study or concomitantly. 13) Pregnant or nursing (lactating) women. 14) Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as: • Surgical sterilization • Hormonal contraception • IUD • Total abstinence throughout the trial at the discretion of the investigator Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the trial. A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child-bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. 15) Subjects with significant diseases, defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject’s ability to participate in the trial; includes subjects with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease. 16) Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related to them. 17) Subject is in custody by order of an authority or a court of law. 18) Subjects with chronic obstructive pulmonary disease (COPD), pertussis or pseudocroup.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: English The objective of this study is to evaluate the efficacy and tolerability of cineole in comparison to placebo, based on the clinical success in patients with acute non-purulent rhinosinusitis with an appearance of sinusitis symptoms not later than 5 days Primary aim: To establish the efficacy of cineole by demonstrating superiority compared to placebo by evaluating the change (difference) of the Major symptom score (MSS): 1. from baseline to day 7 (End-of-treatment, V3) 2. from baseline to day 3 (Interim, V2), (in case of significant result of 1). ;Secondary Objective: – Change (difference) of the Major Symptom Score (MSS) from baseline (V1) to visit V4. – Response to treatment defined as improvement of MSS by >=50% at day 7 (V3) as compared to baseline. – Response to treatment defined as improvement of MSS by >=50% at day 3 (V2) as compared to baseline. – Safety evaluation by comparison of the incidence of adverse events in the treatment groups. – Number of drop-out patients requiring alternative therapy with antibiotics at interim visit at day 3.;Primary end point(s): To establish the efficacy of cineole by demonstrating superiority compared to placebo by evaluating the change (difference) of the Major symptom score (MSS) 1. from baseline (V1) to day 7 (End-of-treatment, V3) 2. baseline (V1) to day 3 (Interim visit, V2) (in case of significant results of 1) ;Timepoint(s) of evaluation of this end point: Day 7 (EOT, V3); Day 3 (Interim visit, V2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change (difference) of the Major Symptom Score (MSS) from baseline (V1) to visit V4. 2) Response to treatment defined as improvement of MSS by >=50% at day 7 (V3) as compared to baseline. 3) Response to treatment defined as improvement of MSS by >=50% at day 3 (V2) as compared to baseline. 4) Safety evaluation by comparison of the incidence of adverse events in the treatment groups. 5) Number of drop-out patients requiring alternative therapy with antibiotics at interim visit at day 3.;Timepoint(s) of evaluation of this end point: 1) Day 14 (V4) 2) Day 7 (V3) 3) Day 3 (V2) 4) Day 14 (V4) 5) Day 3 (V2) | — |
Countries
Germany
Contacts
Public ContactFrankfurt Office
Ecron Acunova GmbH
Outcome results
None listed