ID
44222
Descrizione
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
Keywords
versioni (4)
- 08/03/16 08/03/16 -
- 08/03/16 08/03/16 -
- 13/04/21 13/04/21 - Dr. rer. medic Philipp Neuhaus
- 20/09/21 20/09/21 -
Caricato su
20 settembre 2021
DOI
Per favore, per richiedere un accesso.
Licenza
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
Descrizione
Patient demographics
Descrizione
Date of birth
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0421451 (Patient date of birth)
- SNOMED
- 184099003
- LOINC
- LP57552-9
Descrizione
Height
Tipo di dati
integer
Unità di misura
- cm
Alias
- UMLS CUI [1]
- C0005890 (Body Height)
- SNOMED
- 50373000
Descrizione
Weight
Tipo di dati
integer
Unità di misura
- kg
Alias
- UMLS CUI [1]
- C0005910 (Body Weight)
- SNOMED
- 27113001
Descrizione
Temperatur
Tipo di dati
integer
Unità di misura
- °C
Alias
- UMLS CUI [1]
- C0039476 (Temperature)
- SNOMED
- 703421000
- LOINC
- MTHU009008
Descrizione
Blood pressure
Tipo di dati
integer
Unità di misura
- mmHg
Alias
- UMLS CUI [1]
- C0005823 (Blood Pressure)
- SNOMED
- 75367002
Descrizione
Heart rate
Tipo di dati
integer
Unità di misura
- 1/sec
Alias
- UMLS CUI [1]
- C0018810 (heart rate)
- SNOMED
- 364075005
- LOINC
- LP29713-2
Descrizione
Gender
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0079399 (Gender)
- SNOMED
- 263495000
- LOINC
- LP61312-2
Descrizione
Ethnic Group
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0015031 (Ethnic group)
- SNOMED
- 398089004
- LOINC
- LP36231-6
Descrizione
Medical history of serious illness, accidents, surgeries
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0010340 (Critical Illness)
- UMLS CUI [2]
- C0000924 (Accidents)
- LOINC
- MTHU021177
- UMLS CUI [3]
- C0543467 (Operative Surgical Procedures)
- SNOMED
- 257556004
- LOINC
- LP7802-4
Descrizione
Does the patient suffer from allergies?
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0489531 (History of allergies)
Descrizione
Patient has suffered from chronic sinusitis since:
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0149516 (Chronic sinusitis)
- SNOMED
- 40055000
Descrizione
Inclusion criteria
Descrizione
Initial examination including Ear, Nose and Throat Examination
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C2729337 (undefined)
- UMLS CUI [2]
- C0278350 (ENT examination)
- SNOMED
- 113028003
Descrizione
Patient age
Tipo di dati
boolean
Descrizione
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 di dati
boolean
Alias
- UMLS CUI [1]
- C0149516 (Chronic sinusitis)
- SNOMED
- 40055000
Descrizione
Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C3533163 (Total symptom score)
- LOINC
- LP157096-1
- UMLS CUI [1,2]
- C0037199 (Sinusitis)
- SNOMED
- 36971009
- UMLS CUI [2,1]
- C1299570 (Nasal sinus obstruction)
- SNOMED
- 371126007
- UMLS CUI [2,2]
- C0037199 (Sinusitis)
- SNOMED
- 36971009
Descrizione
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 di dati
boolean
Alias
- UMLS CUI [1,1]
- C0037199 (Sinusitis)
- SNOMED
- 36971009
- UMLS CUI [1,2]
- C1634617 (CT angiography of coronary arteries)
Descrizione
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 di dati
boolean
Alias
- UMLS CUI [1]
- C1142435 (General physical condition)
- LOINC
- LP172762-9
Descrizione
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 di dati
boolean
Alias
- UMLS CUI [1]
- C1740754 (Intermittent asthma)
- SNOMED
- 427603009
Descrizione
Patient on prior medication: Observe wash out times prior to begin of study
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C2826257 (Prior Medication Usage)
Descrizione
Written informed consent based on patient information by physician
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0021430 (Informed Consent)
Descrizione
Footer module
Descrizione
In case one of the above mentioned questions is answered “NO” the patient may not be included into the study.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0680252 (inclusion and exclusion)
Descrizione
Date and signature by physician
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0807937 (Signature date)
- LOINC
- MTHU008294
Descrizione
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251 (Exclusion Criteria)
Descrizione
Patient who do not fulfill all inclusion criteria
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C2827031 (Trial Inclusion Exclusion Criteria Rule)
Descrizione
Patient without contraception, pregnant/ breast-feeding
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0700589 (Contraceptive methods)
- SNOMED
- 13197004
- UMLS CUI [2]
- C0549206 (Patient currently pregnant)
- SNOMED
- 77386006
- LOINC
- LA14670-6
- UMLS CUI [3]
- C0006147 (Breast Feeding)
- SNOMED
- 169741004
- LOINC
- LP420040-0
Descrizione
Patient has undergone nasal operation within the last 6 months
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0188970 (Operation on nose)
- SNOMED
- 88733004
Descrizione
Patient with significant ECG changes
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0855329 (Electrocardiogram change)
Descrizione
Patient with clinically relevant changes of vital bodily function
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0277803 (Normal vital signs)
- SNOMED
- 72970002
Descrizione
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 di dati
boolean
Alias
- UMLS CUI [1]
- C3495801 (Granulomatosis with polyangiitis)
- SNOMED
- 195353004
- UMLS CUI [2,1]
- C0010674 (Cystic Fibrosis)
- SNOMED
- 190905008
- UMLS CUI [2,2]
- C0027430 (Nasal Polyps)
- SNOMED
- 736500007
- UMLS CUI [3]
- C0340037 (Young Syndrome)
- SNOMED
- 233666007
- UMLS CUI [4]
- C0008780 (Ciliary Motility Disorders)
- SNOMED
- 86204009
- UMLS CUI [5]
- C0017601 (Glaucoma)
- SNOMED
- 23986001
- LOINC
- LP74892-8
- UMLS CUI [6]
- C0007222 (Cardiovascular Diseases)
- SNOMED
- 49601007
- UMLS CUI [7]
- C0024115 (Lung diseases)
- SNOMED
- 19829001
- UMLS CUI [8]
- C0022658 (Kidney Diseases)
- SNOMED
- 90708001
- UMLS CUI [9,1]
- C0023895 (Liver diseases)
- SNOMED
- 235856003
- LOINC
- LA17774-3
- UMLS CUI [9,2]
- C0025517 (Metabolic Diseases)
- SNOMED
- 30390004
- UMLS CUI [9,3]
- C0018939 (Hematological Disease)
- SNOMED
- 34093004
- UMLS CUI [9,4]
- C0027765 (nervous system disorder)
- SNOMED
- 118940003
- LOINC
- LA10590-0
- UMLS CUI [10]
- C0021081 (Immunosuppressive Agents)
- SNOMED
- 69431002
- UMLS CUI [11]
- C0008728 (Eosinophilic granulomatosis with polyangiitis)
- SNOMED
- 82275008
Descrizione
Patient on systemic steroid therapy < 4 weeks prior to begin of study
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C4039704 (History of systemic steroid therapy)
- SNOMED
- 134671000119104
Descrizione
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C3539185 (Corticosteroid nasal preparations for topical use)
Descrizione
Drug intolerance to pharmaceutical ingredients of study medication
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0277585 (Intolerance to drug)
- SNOMED
- 59037007
Descrizione
Acute exacerbation of sinusitis or acute nasal infection < 2 weeks prior to begin of examination that required antibiotic therapy.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0235874 (Disease Exacerbation)
- UMLS CUI [1,2]
- C0037199 (Sinusitis)
- SNOMED
- 36971009
- UMLS CUI [1,3]
- C0338237 (Antibiotic therapy)
- SNOMED
- 281789004
Descrizione
Body Temperature > 38.5 °C at start of trial
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0005903 (Body Temperature)
- SNOMED
- 722490005
- LOINC
- LP36617-6
Descrizione
White blood cell count exceeding > 150 % of upper limit
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0580531 (White blood cell count abnormal)
- SNOMED
- 165509000
Descrizione
Acute Upper Respiratory Infection within last two weeks
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0264222 (Acute upper respiratory infection)
- SNOMED
- 54398005
Descrizione
Patient on antibiotic therapy after increase of symptoms during medication phase.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0338237 (Antibiotic therapy)
- SNOMED
- 281789004
Descrizione
Person participating in trial or their relatives
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0008976 (Clinical Trials)
- SNOMED
- 110465008
- LOINC
- LP231796-6
Descrizione
In case one of the above mentioned questions is answered “YES” the patient may not be included into the study.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0680251 (Exclusion Criteria)
Descrizione
Physical Examination
Descrizione
Physical Examination
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0031809 (Physical Examination)
- SNOMED
- 5880005
- LOINC
- MTHU028014
Descrizione
Examination of nose
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0558826 (Examination of nose)
- SNOMED
- 274794006
Descrizione
Anatomic, Congenital , Surgery-induced changes
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0302142 (Deformity)
- SNOMED
- 6081001
- LOINC
- LA18225-5
- UMLS CUI [2]
- C0000768 (Congenital Abnormality)
- SNOMED
- 276654001
Descrizione
Nasal Polyps
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0027430 (Nasal Polyps)
- SNOMED
- 736500007
Descrizione
Endoscopy
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0014245 (Endoscopy (procedure))
- SNOMED
- 423827005
- LOINC
- LP6254-9
Descrizione
Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0438280 (Endoscopy finding)
- SNOMED
- 271936004
Descrizione
Lund-MacKay (LM) CT scoring scale
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0040405 (X-Ray Computed Tomography)
- SNOMED
- 77477000
- LOINC
- LP6207-7
- UMLS CUI [1,2]
- C0036449 (Scoring Methods)
Descrizione
Medication
Descrizione
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 di dati
integer
Alias
- UMLS CUI [1]
- C2347852 (Concomitant Agent)
Descrizione
Please liste all "As Needed" medication
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C3176065 (PRN medicine:Find:Pt:Medication.current:Ord:PhenX)
- LOINC
- 66426-8
Descrizione
Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0677097 (Identify non-drug therapy alternatives)
Descrizione
Signature
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C1519316 (Signature)
- LOINC
- LP248948-4
Descrizione
Laboratory
Descrizione
Blood test
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0018941 (Hematologic Tests)
- SNOMED
- 252275004
Descrizione
Rhinosinusitis Disability Index (RSBI)
Descrizione
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 di dati
integer
Alias
- UMLS CUI [1,1]
- C0948780 (Rhinosinusitis)
- SNOMED
- 897656009
- UMLS CUI [1,2]
- C3826998 (Health Assessment Questionnaire Disability Index With Pain Visual Analog Scale Questionnaire)
- LOINC
- LP186229-3
Descrizione
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 di dati
integer
Alias
- UMLS CUI [1]
- C0681116 (Impaired work performance)
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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