Study schedule - Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis
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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

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2016-03-08 by Johannes Osterloh

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    Study schedule

    Study scheudle

    Name: Study schedule
    Description: Study scheudle

    Name examination / treatment day 1
    Question examination / treatment day 1
    Description examination 1 treatment day 1
    Datatype integer
    Aliases:  
    UMLS CUI [1] C3468389
    Codelistitems  
      Patient informed consent(1)
    UMLS CUI-1: C0021430
      Body temperature(10)
    UMLS CUI-1: C0005903
      Laboratory: Blood count, Clinical Chemistry, Urine(11)
    UMLS CUI-1: C1254595
      Serum Pregnancy Tests (all female patients of reproductive age)(12)
    UMLS CUI-1: C0430064
      Sinusitis-Symptom-Score(13)
    UMLS CUI-1: C0037199
      ...
      There are 17 more items on this list. Click to show them.
      Assessment of patient’s individual symptoms and general examination by treating physician (14)
    UMLS CUI-1: C1317600
    UMLS CUI-2: C0031809
      CodelistItem 802793(15)
      Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment(16)
    UMLS CUI-1: C0743630
    UMLS CUI-2: C0037199
      Handing out of dairy to patient(17)
    UMLS CUI-1: C3890583
      CodelistItem 802796(18)
      Rapid shallow breathing Index (RSBI) questionnaire (Appendix 4)(19)
    UMLS CUI-1: C0425488
      Evaluation inclusion/ exclusion criteria(2)
    UMLS CUI-1: C2827031
      Employability and activity impairment questionnaire(20)
    UMLS CUI-1: C0870486
      CodelistItem 802799(21)
      Collecting and weighing of study medication(22)
    UMLS CUI-1: C0013227
      Review of the patient's general medical history, ENT specific history and allergy history(3)
    UMLS CUI-1: C0262926
    UMLS CUI-2: C0278350
    UMLS CUI-3: C0489531
      Review of simultaneously administered medication(4)
    UMLS CUI-1: C0806914
      General physical examination(5)
    UMLS CUI-1: C0031809
      Assessment of coronary CT of facial bones according to “Lund scale”(6)
    UMLS CUI-1: C1631067
      Nasal examination and endoscopy(7)
    UMLS CUI-1: C2235668
    UMLS CUI-2: C0014245
      Height, Weight(8)
    UMLS CUI-1: C0424638
      Vital signs (blood pressure, heart rate)(9)
    UMLS CUI-1: C0518766
    Name examination 2 / treatment day 8
    Question examination 2 / treatment day 8
    Description examination 2 / treatment day 8
    Datatype integer
    Aliases:  
    UMLS CUI [1] C3468389
    Codelistitems  
      Review of the patient's general medical history, ENT specific history and hypertensivity history(1)
    UMLS CUI-1: C0262926
      Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment(10)
    UMLS CUI-1: C0338237
      Handing out of diary to patient(11)
    UMLS CUI-1: C0872075
      Collecting and reviewing of diary(12)
    UMLS CUI-1: C1736391
      Nasal examination and endoscopy(2)
    UMLS CUI-1: C2239140
      ...
      There are 7 more items on this list. Click to show them.
      Vital signs (blood pressure, heart rate)(3)
    UMLS CUI-1: C0518766
      Body temperature(4)
    UMLS CUI-1: C0005903
      Urine Pregnancy Tests (all female patients of reproductive age)(5)
    UMLS CUI-1: C0430056
      Sinusitis-Symptom-Score(6)
    UMLS CUI-1: C3533163
      Assessment of patient’s individual symptoms and general examination by treating physician (7)
    UMLS CUI-1: C1736323
      Assessment of therapeutic effects by patient(8)
    UMLS CUI-1: C1527144
      Evaluation of adverse events(9)
    UMLS CUI-1: C0877248
    Name examination 3 / treatment day 28
    Question examination 3 / treatment day 28
    Description examination 3 / treatment day 28
    Datatype integer
    Aliases:  
    UMLS CUI [1] C3468389
    Codelistitems  
      Review of the patient's general medical history, ENT specific history and hypertensivity history(1)
    UMLS CUI-1: C0262926
      Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment(10)
    UMLS CUI-1: C0338237
      Handing out of diary to patient(11)
    UMLS CUI-1: C0872075
      Collecting and reviewing of diary(12)
    UMLS CUI-1: C3176968
      Nasal examination and endoscopy(2)
    UMLS CUI-1: C0014245
      ...
      There are 7 more items on this list. Click to show them.
      Vital signs (blood pressure, heart rate)(3)
    UMLS CUI-1: C0518766
      Body temperature(4)
    UMLS CUI-1: C0005903
      Urine Pregnancy Tests (all female patients of reproductive age)(5)
    UMLS CUI-1: C0430056
      Sinusitis-Symptom-Score(6)
    UMLS CUI-1: C3533163
      Assessment of patient’s individual symptoms and general examination by treating physician (7)
    UMLS CUI-1: C0683368
      Assessment of therapeutic effects by patient(8)
    UMLS CUI-1: C1527144
      Evaluation of adverse events(9)
    UMLS CUI-1: C0877248
    Name examination 4 / treatment day 56
    Question examination 4 / treatment day 56
    Description examination 4 / treatment day 56
    Datatype integer
    Aliases:  
    UMLS CUI [1] C3468389
    Codelistitems  
      Review of the patient's general medical history, ENT specific history and hypertensivity history(1)
      Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment(10)
      Handing out of dairy to patient(11)
      Collecting and reviewing of diary(12)
      RSBI questionnaire (Appendix 4)(13)
      ...
      There are 11 more items on this list. Click to show them.
      Collecting and weighing of study medication (14)
      Handing out study medication to patient(15)
      Employability and activity impairment questionnaire(16)
      Nasal examination and endoscopy(2)
      Vital signs (blood pressure, heart rate)(3)
      Body temperature(4)
      Urine Pregnancy Tests (all female patients of reproductive age)(5)
      Sinusitis-Symptom-Score(6)
      Assessment of patient’s individual symptoms and general examination by treating physician (7)
      Assessment of therapeutic effects by patient(8)
      Evaluation of adverse events(9)
    Name examination 5 / treatment day 84
    Question examination 5 / treatment day 84
    Description examination 5 / treatment day 84
    Datatype integer
    Aliases:  
    UMLS CUI [1] C3468389
    Codelistitems  
      Review of the patient's general medical history, ENT specific history and hypertensivity history(1)
      Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment(10)
      Handing out of dairy to patient(11)
      Collecting and reviewing of diary(12)
      RSBI questionnaire (Appendix 4)(13)
      ...
      There are 11 more items on this list. Click to show them.
      Collecting and weighing of study medication (14)
      Handing out study medication to patient(15)
      Employability and activity impairment questionnaire(16)
      Nasal examination and endoscopy(2)
      Vital signs (blood pressure, heart rate)(3)
      Body temperature(4)
      Urine Pregnancy Tests (all female patients of reproductive age)(5)
      Sinusitis-Symptom-Score(6)
      Assessment of patient’s individual symptoms and general examination by treating physician (7)
      Assessment of therapeutic effects by patient(8)
      Evaluation of adverse events(9)
    Name examination 6 / treatment day 112
    Question examination 6 / treatment day 112
    Description examination 6 / treatment day 112
    Datatype integer
    Aliases:  
    UMLS CUI [1] C3468389
    Codelistitems  
      Review of the patient's general medical history, ENT specific history and hypertensivity history(1)
      Assessment, if in the past or since the last appointment an exacerbation of sinusitis has taken place that requires an antibiotic treatment(10)
      Handing out of dairy to patient(11)
      Collecting and reviewing of diary(12)
      RSBI questionnaire (Appendix 4)(13)
      ...
      There are 13 more items on this list. Click to show them.
      Collecting and weighing of study medication (14)
      Handing out study medication to patient(15)
      Employability and activity impairment questionnaire(16)
      Satisfaction questionnaire(17)
      Laboratory: Blood count, Clinical Chemistry, Urine(18)
      Nasal examination and endoscopy(2)
      Vital signs (blood pressure, heart rate)(3)
      Body temperature(4)
      Serume Pregnancy Tests (all female patients of reproductive age)(5)
      Sinusitis-Symptom-Score(6)
      Assessment of patient’s individual symptoms and general examination by treating physician (7)
      Assessment of therapeutic effects by patient(8)
      Evaluation of adverse events(9)

    Concomitant medication

    Name: Concomitant medication
    Description: Concomitant medication

    Name Concomitant medication
    Question Concomitant medication
    Description Admissable Concomitant medication
    Datatype integer
    Aliases:  
    UMLS CUI [1] C2347852
    Codelistitems  
      low dose aspirin for cardiac prevention, up to 325 mg daily(1)
    UMLS CUI-1: C2608320
      oral or inhalative beta antagonists (against asthma)(10)
    UMLS CUI-1: C0001645
      (11)
      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)
    UMLS CUI-1: C0013227
      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)
    UMLS CUI-1: C0000970
      ...
      There are 7 more items on this list. Click to show them.
      Contraceptive, Norplant(3)
    UMLS CUI-1: C0009871
    UMLS CUI-2: C1145675
      Low to medium potency (group 4-7) topical steroids (Stoughton-Cornell-Scale) for dermatological purposes(4)
    UMLS CUI-1: C2064827
      topical vaginal therapeutics against candidiasis(5)
    UMLS CUI-1: C0006840
      CodelistItem 802880(6)
      The following medication have to, if needed, be taken according to a rigid treatment plan(7)
    UMLS CUI-1: C0599880
      oral or inhalative cromolyn or necrodormil (against asthma)(8)
    UMLS CUI-1: C0086073
      oral or inhalative theophylline (against asthma)(9)
    UMLS CUI-1: C0039771
    Name Prohibited Medication
    Question Prohibited Medication
    Description The following drugs may not be used prior to initial examination, and may also not be used during the trial.
    Datatype integer
    Aliases:  
    UMLS CUI [1,1] C0683610
    UMLS CUI [1,2] C0013227
    Codelistitems  
      corticosteroids: oral, IV, rectal(1)
    UMLS CUI-1: C3539185
      Cetrizin, Fexofenadin(10)
    UMLS CUI-1: C1110594
      Astemizol(11)
    UMLS CUI-1: C0085170
      Accolate, Singulair, Zileuton(12)
    UMLS CUI-1: C0526502
    UMLS CUI-3: C0595724
    UMLS CUI-5: C0081408
      decongestion drug/ vasoconstrictor: short-acting versions of pseudoephedrine: oral, topical, nasal, intranasal(13)
    UMLS CUI-1: C0282375
      ...
      There are 14 more items on this list. Click to show them.
      topical nasal, oral or ocular anti-inflammatory drugs(14)
    UMLS CUI-1: C0003209
      nasal Cromolyn(15)
    UMLS CUI-1: C0086073
      nasal atropine or ipratropiumbromid(16)
    UMLS CUI-1: C0700580
      nonsteroidal antiinflammatory drugs(17)
    UMLS CUI-1: C0003211
      topical nasal or oral antifungal agents(18)
    UMLS CUI-1: C0003308
      Guaifenesin(19)
    UMLS CUI-1: C0018305
      corticosteroids: Intra-articular / Intramuscular(2)
    UMLS CUI-1: C0442117
      corticosteroids: intranasal(3)
    UMLS CUI-1: C0304604
      corticosteroids: inhalable(4)
    UMLS CUI-1: C0304604
      potent to super potent corticosteroids (Stoughton-Cornell-Scale )for dermatological purposes(5)
    UMLS CUI-1: C3653503
      antihistamines, Short-acting (e.g. Chlorphenamine)(6)
    UMLS CUI-1: C0008281
    UMLS CUI-2: C0003360
      Clemastine, long-acting(7)
    UMLS CUI-1: C0008929
      long-acting antihistamines (e.g. Loratadin, Terfenadin, Hydroxyzin)(8)
    UMLS CUI-1: C0065180
    UMLS CUI-2: C0003360
      long-acting antihistamines (e.g. Azelastin)(9)
    UMLS CUI-1: C1529656
    UMLS CUI-2: C0003360

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  5. Except as otherwise agreed in writing by the Licensor or as may be otherwise permitted by applicable law, if You Reproduce, Distribute or Publicly Perform the Work either by itself or as part of any Adaptations or Collections, You must not distort, mutilate, modify or take other derogatory action in relation to the Work which would be prejudicial to the Original Author's honor or reputation. Licensor agrees that in those jurisdictions (e.g. Japan), in which any exercise of the right granted in Section 3(b) of this License (the right to make Adaptations) would be deemed to be a distortion, mutilation, modification or other derogatory action prejudicial to the Original Author's honor and reputation, the Licensor will waive or not assert, as appropriate, this Section, to the fullest extent permitted by the applicable national law, to enable You to reasonably exercise Your right under Section 3(b) of this License (right to make Adaptations) but not otherwise.

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UNLESS OTHERWISE MUTUALLY AGREED TO BY THE PARTIES IN WRITING, LICENSOR OFFERS THE WORK AS-IS AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND CONCERNING THE WORK, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF TITLE, MERCHANTIBILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR THE ABSENCE OF LATENT OR OTHER DEFECTS, ACCURACY, OR THE PRESENCE OF ABSENCE OF ERRORS, WHETHER OR NOT DISCOVERABLE. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO SUCH EXCLUSION MAY NOT APPLY TO YOU.

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7. Termination

  1. This License and the rights granted hereunder will terminate automatically upon any breach by You of the terms of this License. Individuals or entities who have received Adaptations or Collections from You under this License, however, will not have their licenses terminated provided such individuals or entities remain in full compliance with those licenses. Sections 1, 2, 5, 6, 7, and 8 will survive any termination of this License.
  2. Subject to the above terms and conditions, the license granted here is perpetual (for the duration of the applicable copyright in the Work). Notwithstanding the above, Licensor reserves the right to release the Work under different license terms or to stop distributing the Work at any time; provided, however that any such election will not serve to withdraw this License (or any other license that has been, or is required to be, granted under the terms of this License), and this License will continue in full force and effect unless terminated as stated above.

8. Miscellaneous

  1. Each time You Distribute or Publicly Perform the Work or a Collection, the Licensor offers to the recipient a license to the Work on the same terms and conditions as the license granted to You under this License.
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  3. If any provision of this License is invalid or unenforceable under applicable law, it shall not affect the validity or enforceability of the remainder of the terms of this License, and without further action by the parties to this agreement, such provision shall be reformed to the minimum extent necessary to make such provision valid and enforceable.
  4. No term or provision of this License shall be deemed waived and no breach consented to unless such waiver or consent shall be in writing and signed by the party to be charged with such waiver or consent.
  5. This License constitutes the entire agreement between the parties with respect to the Work licensed here. There are no understandings, agreements or representations with respect to the Work not specified here. Licensor shall not be bound by any additional provisions that may appear in any communication from You. This License may not be modified without the mutual written agreement of the Licensor and You.
  6. The rights granted under, and the subject matter referenced, in this License were drafted utilizing the terminology of the Berne Convention for the Protection of Literary and Artistic Works (as amended on September 28, 1979), the Rome Convention of 1961, the WIPO Copyright Treaty of 1996, the WIPO Performances and Phonograms Treaty of 1996 and the Universal Copyright Convention (as revised on July 24, 1971). These rights and subject matter take effect in the relevant jurisdiction in which the License terms are sought to be enforced according to the corresponding provisions of the implementation of those treaty provisions in the applicable national law. If the standard suite of rights granted under applicable copyright law includes additional rights not granted under this License, such additional rights are deemed to be included in the License; this License is not intended to restrict the license of any rights under applicable law.