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13816
Beschreibung
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
Stichworte
Versionen (2)
- 08.03.16 08.03.16 -
- 20.09.21 20.09.21 -
Hochgeladen am
8. März 2016
DOI
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Creative Commons BY-NC 3.0
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Study schedule - Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis
Ähnliche Modelle
Study schedule
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
CL Item
Patient informed consent (1)
C0021430 (UMLS CUI-1)
CL Item
Evaluation inclusion/ exclusion criteria (2)
C2827031 (UMLS CUI-1)
CL Item
Review of the patient's general medical history, ENT specific history and allergy history (3)
C0262926 (UMLS CUI-1)
C0278350 (UMLS CUI-2)
C0489531 (UMLS CUI-3)
C0278350 (UMLS CUI-2)
C0489531 (UMLS CUI-3)
CL Item
Review of simultaneously administered medication (4)
C0806914 (UMLS CUI-1)
CL Item
General physical examination (5)
C0031809 (UMLS CUI-1)
CL Item
Assessment of coronary CT of facial bones according to “Lund scale” (6)
C1631067 (UMLS CUI-1)
CL Item
Nasal examination and endoscopy (7)
C2235668 (UMLS CUI-1)
C0014245 (UMLS CUI-2)
C0014245 (UMLS CUI-2)
CL Item
Height, Weight (8)
C0424638 (UMLS CUI-1)
CL Item
Vital signs (blood pressure, heart rate) (9)
C0518766 (UMLS CUI-1)
CL Item
Body temperature (10)
C0005903 (UMLS CUI-1)
CL Item
Laboratory: Blood count, Clinical Chemistry, Urine (11)
C1254595 (UMLS CUI-1)
CL Item
Serum Pregnancy Tests (all female patients of reproductive age) (12)
C0430064 (UMLS CUI-1)
CL Item
Sinusitis-Symptom-Score (13)
C0037199 (UMLS CUI-1)
CL Item
Assessment of patient’s individual symptoms and general examination by treating physician (14)
C1317600 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
CL Item
(15)
CL Item
Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment (16)
C0743630 (UMLS CUI-1)
C0037199 (UMLS CUI-2)
C0037199 (UMLS CUI-2)
CL Item
Handing out of dairy to patient (17)
C3890583 (UMLS CUI-1)
CL Item
(18)
CL Item
Rapid shallow breathing Index (RSBI) questionnaire (Appendix 4) (19)
C0425488 (UMLS CUI-1)
CL Item
Employability and activity impairment questionnaire (20)
C0870486 (UMLS CUI-1)
CL Item
(21)
CL Item
Collecting and weighing of study medication (22)
C0013227 (UMLS CUI-1)
Item
examination 2 / treatment day 8
integer
C3468389 (UMLS CUI [1])
CL Item
Review of the patient's general medical history, ENT specific history and hypertensivity history (1)
C0262926 (UMLS CUI-1)
CL Item
Nasal examination and endoscopy (2)
C2239140 (UMLS CUI-1)
CL Item
Vital signs (blood pressure, heart rate) (3)
C0518766 (UMLS CUI-1)
CL Item
Body temperature (4)
C0005903 (UMLS CUI-1)
CL Item
Urine Pregnancy Tests (all female patients of reproductive age) (5)
C0430056 (UMLS CUI-1)
CL Item
Sinusitis-Symptom-Score (6)
C3533163 (UMLS CUI-1)
CL Item
Assessment of patient’s individual symptoms and general examination by treating physician (7)
C1736323 (UMLS CUI-1)
CL Item
Assessment of therapeutic effects by patient (8)
C1527144 (UMLS CUI-1)
CL Item
Evaluation of adverse events (9)
C0877248 (UMLS CUI-1)
CL Item
Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment (10)
C0338237 (UMLS CUI-1)
CL Item
Handing out of diary to patient (11)
C0872075 (UMLS CUI-1)
CL Item
Collecting and reviewing of diary (12)
C1736391 (UMLS CUI-1)
Item
examination 3 / treatment day 28
integer
C3468389 (UMLS CUI [1])
CL Item
Review of the patient's general medical history, ENT specific history and hypertensivity history (1)
C0262926 (UMLS CUI-1)
CL Item
Nasal examination and endoscopy (2)
C0014245 (UMLS CUI-1)
CL Item
Vital signs (blood pressure, heart rate) (3)
C0518766 (UMLS CUI-1)
CL Item
Body temperature (4)
C0005903 (UMLS CUI-1)
CL Item
Urine Pregnancy Tests (all female patients of reproductive age) (5)
C0430056 (UMLS CUI-1)
CL Item
Sinusitis-Symptom-Score (6)
C3533163 (UMLS CUI-1)
CL Item
Assessment of patient’s individual symptoms and general examination by treating physician (7)
C0683368 (UMLS CUI-1)
CL Item
Assessment of therapeutic effects by patient (8)
C1527144 (UMLS CUI-1)
CL Item
Evaluation of adverse events (9)
C0877248 (UMLS CUI-1)
CL Item
Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment (10)
C0338237 (UMLS CUI-1)
CL Item
Handing out of diary to patient (11)
C0872075 (UMLS CUI-1)
CL Item
Collecting and reviewing of diary (12)
C3176968 (UMLS CUI-1)
Item
examination 4 / treatment day 56
integer
C3468389 (UMLS CUI [1])
CL Item
Review of the patient's general medical history, ENT specific history and hypertensivity history (1)
CL Item
Nasal examination and endoscopy (2)
CL Item
Vital signs (blood pressure, heart rate) (3)
CL Item
Body temperature (4)
CL Item
Urine Pregnancy Tests (all female patients of reproductive age) (5)
CL Item
Sinusitis-Symptom-Score (6)
CL Item
Assessment of patient’s individual symptoms and general examination by treating physician (7)
CL Item
Assessment of therapeutic effects by patient (8)
CL Item
Evaluation of adverse events (9)
CL Item
Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment (10)
CL Item
Handing out of dairy to patient (11)
CL Item
Collecting and reviewing of diary (12)
CL Item
RSBI questionnaire (Appendix 4) (13)
CL Item
Collecting and weighing of study medication (14)
CL Item
Handing out study medication to patient (15)
CL Item
Employability and activity impairment questionnaire (16)
Item
examination 5 / treatment day 84
integer
C3468389 (UMLS CUI [1])
CL Item
Review of the patient's general medical history, ENT specific history and hypertensivity history (1)
CL Item
Nasal examination and endoscopy (2)
CL Item
Vital signs (blood pressure, heart rate) (3)
CL Item
Body temperature (4)
CL Item
Urine Pregnancy Tests (all female patients of reproductive age) (5)
CL Item
Sinusitis-Symptom-Score (6)
CL Item
Assessment of patient’s individual symptoms and general examination by treating physician (7)
CL Item
Assessment of therapeutic effects by patient (8)
CL Item
Evaluation of adverse events (9)
CL Item
Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment (10)
CL Item
Handing out of dairy to patient (11)
CL Item
Collecting and reviewing of diary (12)
CL Item
RSBI questionnaire (Appendix 4) (13)
CL Item
Collecting and weighing of study medication (14)
CL Item
Handing out study medication to patient (15)
CL Item
Employability and activity impairment questionnaire (16)
Item
examination 6 / treatment day 112
integer
C3468389 (UMLS CUI [1])
CL Item
Review of the patient's general medical history, ENT specific history and hypertensivity history (1)
CL Item
Nasal examination and endoscopy (2)
CL Item
Vital signs (blood pressure, heart rate) (3)
CL Item
Body temperature (4)
CL Item
Serume Pregnancy Tests (all female patients of reproductive age) (5)
CL Item
Sinusitis-Symptom-Score (6)
CL Item
Assessment of patient’s individual symptoms and general examination by treating physician (7)
CL Item
Assessment of therapeutic effects by patient (8)
CL Item
Evaluation of adverse events (9)
CL Item
Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment (10)
CL Item
Handing out of dairy to patient (11)
CL Item
Collecting and reviewing of diary (12)
CL Item
RSBI questionnaire (Appendix 4) (13)
CL Item
Collecting and weighing of study medication (14)
CL Item
Handing out study medication to patient (15)
CL Item
Employability and activity impairment questionnaire (16)
CL Item
Satisfaction questionnaire (17)
CL Item
Laboratory: Blood count, Clinical Chemistry, Urine (18)
CL Item
low dose aspirin for cardiac prevention, up to 325 mg daily (1)
C2608320 (UMLS CUI-1)
CL Item
Paracetamol if needed (Paracetamol is the recommended analgesic. If this is no sufficient, NSAID may be used restrictedly; NSAID treatment may not exceed 5 consecutive days) (2)
C0000970 (UMLS CUI-1)
CL Item
Contraceptive, Norplant (3)
C0009871 (UMLS CUI-1)
C1145675 (UMLS CUI-2)
C1145675 (UMLS CUI-2)
CL Item
Low to medium potency (group 4-7) topical steroids (Stoughton-Cornell-Scale) for dermatological purposes (4)
C2064827 (UMLS CUI-1)
CL Item
topical vaginal therapeutics against candidiasis (5)
C0006840 (UMLS CUI-1)
CL Item
(6)
CL Item
The following medication have to, if needed, be taken according to a rigid treatment plan (7)
C0599880 (UMLS CUI-1)
CL Item
oral or inhalative cromolyn or necrodormil (against asthma) (8)
C0086073 (UMLS CUI-1)
CL Item
oral or inhalative theophylline (against asthma) (9)
C0039771 (UMLS CUI-1)
CL Item
oral or inhalative beta antagonists (against asthma) (10)
C0001645 (UMLS CUI-1)
CL Item
(11)
CL Item
Other drugs may be used during the trial unless they are excluded by the protocol, e.g. Central nervous system agents, hormones, diabetes medication, nonsteroidal ophthalmic drugs (12)
C0013227 (UMLS CUI-1)
Item
Prohibited Medication
integer
C0683610 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
corticosteroids: oral, IV, rectal (1)
C3539185 (UMLS CUI-1)
CL Item
corticosteroids: Intra-articular / Intramuscular (2)
C0442117 (UMLS CUI-1)
CL Item
corticosteroids: intranasal (3)
C0304604 (UMLS CUI-1)
CL Item
corticosteroids: inhalable (4)
C0304604 (UMLS CUI-1)
CL Item
potent to super potent corticosteroids (Stoughton-Cornell-Scale )for dermatological purposes (5)
C3653503 (UMLS CUI-1)
CL Item
antihistamines, Short-acting (e.g. Chlorphenamine) (6)
C0008281 (UMLS CUI-1)
C0003360 (UMLS CUI-2)
C0003360 (UMLS CUI-2)
CL Item
Clemastine, long-acting (7)
C0008929 (UMLS CUI-1)
CL Item
long-acting antihistamines (e.g. Loratadin, Terfenadin, Hydroxyzin) (8)
C0065180 (UMLS CUI-1)
C0003360 (UMLS CUI-2)
C0003360 (UMLS CUI-2)
CL Item
long-acting antihistamines (e.g. Azelastin) (9)
C1529656 (UMLS CUI-1)
C0003360 (UMLS CUI-2)
C0003360 (UMLS CUI-2)
CL Item
Cetrizin, Fexofenadin (10)
C1110594 (UMLS CUI-1)
CL Item
Astemizol (11)
C0085170 (UMLS CUI-1)
CL Item
Accolate, Singulair, Zileuton (12)
C0526502 (UMLS CUI-1)
C0595724 (UMLS CUI-3)
C0081408 (UMLS CUI-5)
C0595724 (UMLS CUI-3)
C0081408 (UMLS CUI-5)
CL Item
decongestion drug/ vasoconstrictor: short-acting versions of pseudoephedrine: oral, topical, nasal, intranasal (13)
C0282375 (UMLS CUI-1)
CL Item
topical nasal, oral or ocular anti-inflammatory drugs (14)
C0003209 (UMLS CUI-1)
CL Item
nasal Cromolyn (15)
C0086073 (UMLS CUI-1)
CL Item
nasal atropine or ipratropiumbromid (16)
C0700580 (UMLS CUI-1)
CL Item
nonsteroidal antiinflammatory drugs (17)
C0003211 (UMLS CUI-1)
CL Item
topical nasal or oral antifungal agents (18)
C0003308 (UMLS CUI-1)
CL Item
Guaifenesin (19)
C0018305 (UMLS CUI-1)