ID
44222
Descripción
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
Palabras clave
Versiones (4)
- 8/3/16 8/3/16 -
- 8/3/16 8/3/16 -
- 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
- 20/9/21 20/9/21 -
Subido en
20 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Patient demographics
Descripción
Date of birth
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0421451
Descripción
Height
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
Weight
Tipo de datos
integer
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Temperatur
Tipo de datos
integer
Unidades de medida
- °C
Alias
- UMLS CUI [1]
- C0039476
Descripción
Blood pressure
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Descripción
Heart rate
Tipo de datos
integer
Unidades de medida
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Descripción
Gender
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0079399
Descripción
Ethnic Group
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0015031
Descripción
Medical history of serious illness, accidents, surgeries
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0010340
- UMLS CUI [2]
- C0000924
- UMLS CUI [3]
- C0543467
Descripción
Does the patient suffer from allergies?
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0489531
Descripción
Patient has suffered from chronic sinusitis since:
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0149516
Descripción
Inclusion criteria
Descripción
Initial examination including Ear, Nose and Throat Examination
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2729337
- UMLS CUI [2]
- C0278350
Descripción
Patient age
Tipo de datos
boolean
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0149516
Descripción
Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3533163
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [2,1]
- C1299570
- UMLS CUI [2,2]
- C0037199
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0037199
- UMLS CUI [1,2]
- C1634617
Descripción
Patient in good general condition without clinically significant disease which could affect study goal or study methods or which might impair patient´s safety.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1142435
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1740754
Descripción
Patient on prior medication: Observe wash out times prior to begin of study
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826257
Descripción
Written informed consent based on patient information by physician
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
Descripción
Footer module
Descripción
In case one of the above mentioned questions is answered “NO” the patient may not be included into the study.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0680252
Descripción
Date and signature by physician
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0807937
Descripción
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
Patient who do not fulfill all inclusion criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2827031
Descripción
Patient without contraception, pregnant/ breast-feeding
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0700589
- UMLS CUI [2]
- C0549206
- UMLS CUI [3]
- C0006147
Descripción
Patient has undergone nasal operation within the last 6 months
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0188970
Descripción
Patient with significant ECG changes
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0855329
Descripción
Patient with clinically relevant changes of vital bodily function
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0277803
Descripción
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
Tipo de datos
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
Descripción
Patient on systemic steroid therapy < 4 weeks prior to begin of study
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C4039704
Descripción
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3539185
Descripción
Drug intolerance to pharmaceutical ingredients of study medication
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0277585
Descripción
Acute exacerbation of sinusitis or acute nasal infection < 2 weeks prior to begin of examination that required antibiotic therapy.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0235874
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [1,3]
- C0338237
Descripción
Body Temperature > 38.5 °C at start of trial
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005903
Descripción
White blood cell count exceeding > 150 % of upper limit
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0580531
Descripción
Acute Upper Respiratory Infection within last two weeks
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0264222
Descripción
Patient on antibiotic therapy after increase of symptoms during medication phase.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0338237
Descripción
Person participating in trial or their relatives
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0008976
Descripción
In case one of the above mentioned questions is answered “YES” the patient may not be included into the study.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0680251
Descripción
Physical Examination
Descripción
Physical Examination
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0031809
Descripción
Examination of nose
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0558826
Descripción
Anatomic, Congenital , Surgery-induced changes
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0302142
- UMLS CUI [2]
- C0000768
Descripción
Nasal Polyps
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0027430
Descripción
Endoscopy
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0014245
Descripción
Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0438280
Descripción
Lund-MacKay (LM) CT scoring scale
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0036449
Descripción
Medication
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2347852
Descripción
Please liste all "As Needed" medication
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3176065
Descripción
Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0677097
Descripción
Signature
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1519316
Descripción
Laboratory
Descripción
Blood test
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0018941
Descripción
Rhinosinusitis Disability Index (RSBI)
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0948780
- UMLS CUI [1,2]
- C3826998
Descripción
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:
Tipo de datos
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])