ID
42222
Beskrivning
This study evaluates the effectiveness and safety of MFNS in improving the Treatment of Chronic Sinusitis. ODM derived from:"Randomized Double-blind Clinical Trial on the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) or Placebo in the Treatment of Chronic Sinusitis". Leader of the clinical trial: Prof. Dr. med. Karl Hörmann Direktor der Hals-Nasen-Ohren-Klinik / Clinic Director Ear, Nose and Throat Clinic Medical Faculty Mannheim Heidelberg University at the University Medical Centre Mannheim Theodor-Kutzer-Ufer 1-3 68167 Mannheim
Nyckelord
Versioner (4)
- 2016-03-08 2016-03-08 -
- 2016-03-08 2016-03-08 -
- 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
- 2021-09-20 2021-09-20 -
Uppladdad den
13 april 2021
DOI
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Licens
Creative Commons BY-NC 3.0
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Visit 1 - Baseline Form Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis
Visit 1 - Baseline Form
- StudyEvent: ODM
Beskrivning
Patient demographics
Beskrivning
Date of birth
Datatyp
integer
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
integer
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Temperatur
Datatyp
integer
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0039476
Beskrivning
Blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Gender
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Ethnic Group
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
Medical history of serious illness, accidents, surgeries
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0010340
- UMLS CUI [2]
- C0000924
- UMLS CUI [3]
- C0543467
Beskrivning
Does the patient suffer from allergies?
Datatyp
integer
Alias
- UMLS CUI [1]
- C0489531
Beskrivning
Patient has suffered from chronic sinusitis since:
Datatyp
integer
Alias
- UMLS CUI [1]
- C0149516
Beskrivning
Inclusion criteria
Beskrivning
Initial examination including Ear, Nose and Throat Examination
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2729337
- UMLS CUI [2]
- C0278350
Beskrivning
Patient age
Datatyp
boolean
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0149516
Beskrivning
Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3533163
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [2,1]
- C1299570
- UMLS CUI [2,2]
- C0037199
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037199
- UMLS CUI [1,2]
- C1634617
Beskrivning
Patient in good general condition without clinically significant disease which could affect study goal or study methods or which might impair patient´s safety.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1142435
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1740754
Beskrivning
Patient on prior medication: Observe wash out times prior to begin of study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826257
Beskrivning
Written informed consent based on patient information by physician
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Footer module
Beskrivning
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Patient who do not fulfill all inclusion criteria
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2827031
Beskrivning
Patient without contraception, pregnant/ breast-feeding
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700589
- UMLS CUI [2]
- C0549206
- UMLS CUI [3]
- C0006147
Beskrivning
Patient has undergone nasal operation within the last 6 months
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0188970
Beskrivning
Patient with significant ECG changes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0855329
Beskrivning
Patient with clinically relevant changes of vital bodily function
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0277803
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3495801
- UMLS CUI [2,1]
- C0010674
- UMLS CUI [2,2]
- C0027430
- UMLS CUI [3]
- C0340037
- UMLS CUI [4]
- C0008780
- UMLS CUI [5]
- C0017601
- UMLS CUI [6]
- C0007222
- UMLS CUI [7]
- C0024115
- UMLS CUI [8]
- C0022658
- UMLS CUI [9,1]
- C0023895
- UMLS CUI [9,2]
- C0025517
- UMLS CUI [9,3]
- C0018939
- UMLS CUI [9,4]
- C0027765
- UMLS CUI [10]
- C0021081
- UMLS CUI [11]
- C0008728
Beskrivning
Patient on systemic steroid therapy < 4 weeks prior to begin of study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C4039704
Beskrivning
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3539185
Beskrivning
Drug intolerance to pharmaceutical ingredients of study medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0277585
Beskrivning
Acute exacerbation of sinusitis or acute nasal infection < 2 weeks prior to begin of examination that required antibiotic therapy.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0235874
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [1,3]
- C0338237
Beskrivning
Body Temperature > 38.5 °C at start of trial
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
White blood cell count exceeding > 150 % of upper limit
Datatyp
integer
Alias
- UMLS CUI [1]
- C0580531
Beskrivning
Acute Upper Respiratory Infection within last two weeks
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264222
Beskrivning
Patient on antibiotic therapy after increase of symptoms during medication phase.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0338237
Beskrivning
Person participating in trial or their relatives
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008976
Beskrivning
In case one of the above mentioned questions is answered “YES” the patient may not be included into the study.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0680251
Beskrivning
Physical Examination
Beskrivning
Physical Examination
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Examination of nose
Datatyp
integer
Alias
- UMLS CUI [1]
- C0558826
Beskrivning
Anatomic, Congenital , Surgery-induced changes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0302142
- UMLS CUI [2]
- C0000768
Beskrivning
Nasal Polyps
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0027430
Beskrivning
Endoscopy
Datatyp
integer
Alias
- UMLS CUI [1]
- C0014245
Beskrivning
Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438280
Beskrivning
Lund-MacKay (LM) CT scoring scale
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0036449
Beskrivning
Medication
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Please liste all "As Needed" medication
Datatyp
integer
Alias
- UMLS CUI [1]
- C3176065
Beskrivning
Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0677097
Beskrivning
Signature
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519316
Beskrivning
Laboratory
Beskrivning
Blood test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beskrivning
Rhinosinusitis Disability Index (RSBI)
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0948780
- UMLS CUI [1,2]
- C3826998
Beskrivning
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:
Datatyp
integer
Alias
- UMLS CUI [1]
- C0681116
Similar models
Visit 1 - Baseline Form
- StudyEvent: ODM
C0000924 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0278350 (UMLS CUI [2])
C0037199 (UMLS CUI [1,2])
C1299570 (UMLS CUI [2,1])
C0037199 (UMLS CUI [2,2])
C1634617 (UMLS CUI [1,2])
C0549206 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0010674 (UMLS CUI [2,1])
C0027430 (UMLS CUI [2,2])
C0340037 (UMLS CUI [3])
C0008780 (UMLS CUI [4])
C0017601 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0023895 (UMLS CUI [9,1])
C0025517 (UMLS CUI [9,2])
C0018939 (UMLS CUI [9,3])
C0027765 (UMLS CUI [9,4])
C0021081 (UMLS CUI [10])
C0008728 (UMLS CUI [11])
C0037199 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
C0000768 (UMLS CUI [2])
C0036449 (UMLS CUI [1,2])
C3826998 (UMLS CUI [1,2])
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