ID
44222
Description
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
Mots-clés
Versions (4)
- 08/03/2016 08/03/2016 -
- 08/03/2016 08/03/2016 -
- 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
- 20/09/2021 20/09/2021 -
Téléchargé le
20 septembre 2021
DOI
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Licence
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
Description
Patient demographics
Description
Date of birth
Type de données
integer
Alias
- UMLS CUI [1]
- C0421451
Description
Height
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Type de données
integer
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Temperatur
Type de données
integer
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0039476
Description
Blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Heart rate
Type de données
integer
Unités de mesure
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Description
Gender
Type de données
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnic Group
Type de données
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Medical history of serious illness, accidents, surgeries
Type de données
boolean
Alias
- UMLS CUI [1]
- C0010340
- UMLS CUI [2]
- C0000924
- UMLS CUI [3]
- C0543467
Description
Does the patient suffer from allergies?
Type de données
integer
Alias
- UMLS CUI [1]
- C0489531
Description
Patient has suffered from chronic sinusitis since:
Type de données
integer
Alias
- UMLS CUI [1]
- C0149516
Description
Inclusion criteria
Description
Initial examination including Ear, Nose and Throat Examination
Type de données
boolean
Alias
- UMLS CUI [1]
- C2729337
- UMLS CUI [2]
- C0278350
Description
Patient age
Type de données
boolean
Description
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0149516
Description
Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3533163
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [2,1]
- C1299570
- UMLS CUI [2,2]
- C0037199
Description
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
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0037199
- UMLS CUI [1,2]
- C1634617
Description
Patient in good general condition without clinically significant disease which could affect study goal or study methods or which might impair patient´s safety.
Type de données
boolean
Alias
- UMLS CUI [1]
- C1142435
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1]
- C1740754
Description
Patient on prior medication: Observe wash out times prior to begin of study
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826257
Description
Written informed consent based on patient information by physician
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Footer module
Description
In case one of the above mentioned questions is answered “NO” the patient may not be included into the study.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0680252
Description
Date and signature by physician
Type de données
integer
Alias
- UMLS CUI [1]
- C0807937
Description
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Description
Patient who do not fulfill all inclusion criteria
Type de données
boolean
Alias
- UMLS CUI [1]
- C2827031
Description
Patient without contraception, pregnant/ breast-feeding
Type de données
boolean
Alias
- UMLS CUI [1]
- C0700589
- UMLS CUI [2]
- C0549206
- UMLS CUI [3]
- C0006147
Description
Patient has undergone nasal operation within the last 6 months
Type de données
boolean
Alias
- UMLS CUI [1]
- C0188970
Description
Patient with significant ECG changes
Type de données
boolean
Alias
- UMLS CUI [1]
- C0855329
Description
Patient with clinically relevant changes of vital bodily function
Type de données
boolean
Alias
- UMLS CUI [1]
- C0277803
Description
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
Type de données
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
Description
Patient on systemic steroid therapy < 4 weeks prior to begin of study
Type de données
boolean
Alias
- UMLS CUI [1]
- C4039704
Description
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
Type de données
boolean
Alias
- UMLS CUI [1]
- C3539185
Description
Drug intolerance to pharmaceutical ingredients of study medication
Type de données
boolean
Alias
- UMLS CUI [1]
- C0277585
Description
Acute exacerbation of sinusitis or acute nasal infection < 2 weeks prior to begin of examination that required antibiotic therapy.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0235874
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [1,3]
- C0338237
Description
Body Temperature > 38.5 °C at start of trial
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005903
Description
White blood cell count exceeding > 150 % of upper limit
Type de données
integer
Alias
- UMLS CUI [1]
- C0580531
Description
Acute Upper Respiratory Infection within last two weeks
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264222
Description
Patient on antibiotic therapy after increase of symptoms during medication phase.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0338237
Description
Person participating in trial or their relatives
Type de données
boolean
Alias
- UMLS CUI [1]
- C0008976
Description
In case one of the above mentioned questions is answered “YES” the patient may not be included into the study.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0680251
Description
Physical Examination
Description
Physical Examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0031809
Description
Examination of nose
Type de données
integer
Alias
- UMLS CUI [1]
- C0558826
Description
Anatomic, Congenital , Surgery-induced changes
Type de données
boolean
Alias
- UMLS CUI [1]
- C0302142
- UMLS CUI [2]
- C0000768
Description
Nasal Polyps
Type de données
boolean
Alias
- UMLS CUI [1]
- C0027430
Description
Endoscopy
Type de données
integer
Alias
- UMLS CUI [1]
- C0014245
Description
Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major
Type de données
integer
Alias
- UMLS CUI [1]
- C0438280
Description
Lund-MacKay (LM) CT scoring scale
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0036449
Description
Medication
Description
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.
Type de données
integer
Alias
- UMLS CUI [1]
- C2347852
Description
Please liste all "As Needed" medication
Type de données
integer
Alias
- UMLS CUI [1]
- C3176065
Description
Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.
Type de données
integer
Alias
- UMLS CUI [1]
- C0677097
Description
Signature
Type de données
integer
Alias
- UMLS CUI [1]
- C1519316
Description
Laboratory
Description
Blood test
Type de données
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Rhinosinusitis Disability Index (RSBI)
Description
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.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0948780
- UMLS CUI [1,2]
- C3826998
Description
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:
Type de données
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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