Patient demographics
Date of birth
integer
Height
integer
Weight
integer
Temperatur
integer
Blood pressure
integer
Heart rate
integer
Gender
integer
Ethnic Group
integer
Medical history of serious illness, accidents, surgeries
boolean
Does the patient suffer from allergies?
integer
Patient has suffered from chronic sinusitis since:
integer
Inclusion criteria
Initial examination including Ear, Nose and Throat Examination
boolean
Patient age
boolean
Patient with chronic sinusitis for more than 8 weeks or with more than 4 periods during at least 10 days/year (nasal obstruction and unspecific headache, rhinorrhea, post-nasal-drip, facial pain, facial pressure
boolean
Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2
boolean
Sinusitis diagnostics via coronary CT not older than 6 month. Sinusitis diagnosis and scale: osteo-meatal complex score= 2 on at least one side, total score < 10
boolean
Patient in good general condition without clinically significant disease which could affect study goal or study methods or which might impair patient´s safety.
boolean
Patient with stable intermittent asthma: No medication at all or no medication with Beta-2 adrenergic receptor antagonists and without systemic, intranasal or inhaled corticosteroids medication.
boolean
Patient on prior medication: Observe wash out times prior to begin of study
boolean
Written informed consent based on patient information by physician
boolean
Footer module
Exclusion criteria
Patient who do not fulfill all inclusion criteria
boolean
Patient without contraception, pregnant/ breast-feeding
boolean
Patient has undergone nasal operation within the last 6 months
boolean
Patient with significant ECG changes
boolean
Patient with clinically relevant changes of vital bodily function
boolean
Patient with Wegener's granulomatosis, Cystic fibrosis, Nasal polyp, Young syndrome, Primary ciliary dyskinesia, Glaucoma, cardiovascular, pulmonary, renal, hepatic, metabolic, hematological or neurological disease, that may impair with the therapy, patient on immunosuppressive agents or with Churg–Strauss syndrome
boolean
Patient on systemic steroid therapy < 4 weeks prior to begin of study
boolean
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
boolean
Drug intolerance to pharmaceutical ingredients of study medication
boolean
Acute exacerbation of sinusitis or acute nasal infection < 2 weeks prior to begin of examination that required antibiotic therapy.
boolean
Body Temperature > 38.5 °C at start of trial
boolean
White blood cell count exceeding > 150 % of upper limit
integer
Acute Upper Respiratory Infection within last two weeks
boolean
Patient on antibiotic therapy after increase of symptoms during medication phase.
boolean
Person participating in trial or their relatives
boolean
In case one of the above mentioned questions is answered “YES” the patient may not be included into the study.
boolean
Physical Examination
Physical Examination
integer
Examination of nose
integer
Anatomic, Congenital , Surgery-induced changes
boolean
Nasal Polyps
boolean
Endoscopy
integer
Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major
integer
Lund-MacKay (LM) CT scoring scale
integer
Medication
Please list all drugs that the patient is taking at the start of this trial or that he will be taking during this trial. Please also note change of dosage. Please observe excluded drugs under the exclusion criteria section of this form.
integer
Please liste all "As Needed" medication
integer
Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.
integer
Signature
integer
Laboratory
Blood test
integer
Rhinosinusitis Disability Index (RSBI)
The Rhinosinusitis Disability Index (RSDI) is a measure of sinus-related disability. It is a standardized, statistically validated, disease-specific tool and used to investigate the disability suffered patients with rhinologic diagnosis.
integer
The following questions refer to the effects of chronic sinusitis on your ability to work and your daily activities. Please check the following boxes: 1. Are you currently employed? If no, please continue with question No. 6. The next questions refer to the last 7 days, today excluded: 2. How many hours of work did you miss in the last 7 days due to problems or discomfort resulting from your chronic sinusitis? 3. How many hours of work did you miss in the last 7 days due to other reasons such as holidays or because of participating at this trial? 4. How many hours did you work in the last 7 days in total? If you insert 0 hours, please skip the next question and continue with question 6. 5. How did the chronic sinusitis affect your performance at work in the last 7 days? Please take into consideration those days when the amount and type of work you could accomplish was reduced. Also consider those days when you accomplished less than you had planned to and you did not work as diligently as usual. If the chronic sinusitis had only a minor effect on your work please mark a low number. Mark a high number if you experienced a more severe impairment: 6. How did the chronic sinusitis affect your regular daily activities that are not work related in the last 7 days? Regular activities refer to house and garden work, shopping, education, sport etc.. Please consider the type and amount of your daily activities you could not do. Also consider those days when you accomplished less than you had planned to. If the chronic sinusitis had only a minor effect on your work please mark a low number. Mark a high number if you experienced a more severe impairment:
integer