Age | Racial group Any
Item
subjects must be at least 18 years of age, of either gender and any race.
boolean
C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Nasal Polyps Bilateral | Recurrent disease Post Excision | Nasal Polyps Grade Score | Nasal sinus Symptoms | Nasal opacity Bilateral X-Ray Computed Tomography | Nasal Polyps Visible Endoscopy
Item
subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the scoring system described in table 5. bilateral nasal polyposis is defined as sinus symptoms for more than 3 months, bilateral opacity on ct-scan imaging and visible nasal polyps at endoscopy.
boolean
C0027430 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
C0027430 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0449820 (UMLS CUI [3,3])
C0030471 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C3672025 (UMLS CUI [5,1])
C0238767 (UMLS CUI [5,2])
C0040405 (UMLS CUI [5,3])
C0027430 (UMLS CUI [6,1])
C0205379 (UMLS CUI [6,2])
C0014245 (UMLS CUI [6,3])
Asthma Duration | Overall Well Being | Disease Free of | Disease Interferes with Study Protocol | Disease compromises patient safety
Item
subjects must have a diagnosis of asthma for more than 2 years. subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
boolean
C0004096 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C3813622 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
Informed Consent | Protocol Compliance | Pharmaceutical Preparations Restriction | Subject Diary Perform
Item
subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0443288 (UMLS CUI [3,2])
C3890583 (UMLS CUI [4,1])
C0884358 (UMLS CUI [4,2])
Upper Respiratory Infection Free of
Item
subjects must be free of any upper respiratory tract infection within two weeks prior to inclusion.
boolean
C0041912 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
Normal Laboratory Test Result
Item
clinical laboratory tests must be within normal limits or clinically acceptable for the investigator.
boolean
C0438214 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Hormonal contraception | Combined Oral Contraceptives | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Partner had vasectomy | Condoms, Male | Childbearing Potential Sexually active Barrier Contraception | Female Sterilization | Postmenopausal state | Gender Urine pregnancy test negative | Gender Pregnancy Tests Monthly
Item
non-pregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. this includes: a) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); b) medically prescribed intra-uterine device (iud); c) condom in combination with a spermicide; d) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. they must have started this birth control method at least three months prior to screening (with the exception of condom in combination with a spermicide), and they must agree to continue its use for at least 3 months after last dosing. women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. women who are surgically sterilized or are at least one year postmenopausal are considered not to be of childbearing potential. however, all female subjects must have a urine pregnancy test prior to treatment, which must be negative. a monthly-control pregnancy test is requested.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0009906 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C0420842 (UMLS CUI [7])
C0009653 (UMLS CUI [8])
C3831118 (UMLS CUI [9,1])
C0241028 (UMLS CUI [9,2])
C0004764 (UMLS CUI [9,3])
C0015787 (UMLS CUI [10])
C0232970 (UMLS CUI [11])
C0079399 (UMLS CUI [12,1])
C0430057 (UMLS CUI [12,2])
C0079399 (UMLS CUI [13,1])
C0032976 (UMLS CUI [13,2])
C0332177 (UMLS CUI [13,3])
Gender Contraceptive methods | Condoms, Male | Spermatocidal Agents | Heterosexual relationship Partner Contraceptive methods
Item
male subjects must agree to use an adequate form of birth control from first dosing to at least 3 months after last dosing. they must either agree to use a condom with spermicide or agree to have sexual relations only with women using medically acceptable forms of birth control as described above.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009653 (UMLS CUI [2])
C0037862 (UMLS CUI [3])
C0556476 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Premenarche
Item
women must not be pregnant, breast feeding, or premenarcheal.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C2609149 (UMLS CUI [3])
Age
Item
patients younger than 18 years old.
boolean
C0001779 (UMLS CUI [1])
Systemic Reaction Investigational New Drugs
Item
subjects with history of systemic reactions to the study medication.
boolean
C1710276 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Illicit Drugs | Washout Period Lacking
Item
subjects with prohibited medication at screening without full wash-out period.
boolean
C0086190 (UMLS CUI [1])
C1710661 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Acute sinusitis | Nasal infection | Upper Respiratory Infection
Item
subjects with acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within two weeks of the inclusion are excluded.
boolean
C0149512 (UMLS CUI [1])
C0555970 (UMLS CUI [2])
C0041912 (UMLS CUI [3])
Cystic Fibrosis | Ciliary Motility Disorders | Kartagener Syndrome
Item
subjects with cystic fibrosis, primary ciliary's dysfunction or kartagener's syndrome by history are excluded.
boolean
C0010674 (UMLS CUI [1])
C0008780 (UMLS CUI [2])
C0022521 (UMLS CUI [3])
Parasitic Disease
Item
subjects must not have ever been diagnosed with a parasitic infection.
boolean
C0030499 (UMLS CUI [1])
Malignant Neoplasm
Item
subjects must not have ever been diagnosed with cancer
boolean
C0006826 (UMLS CUI [1])
HIV Infection | Hepatitis B | Hepatitis C
Item
subjects must not have a medical history of human immunodeficiency virus (hiv) or hepatitis b or c. testing will not be done at screening.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Asthma attack Requirement Hospital admission | Emergency department patient visit Excluded
Item
subjects must not have had an acute asthmatic attack requiring admission to a hospital (excluding emergency room visits which resulted in direct discharge without hospitalization) within the four weeks prior to screening.
boolean
C0347950 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,3])
C0586082 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Immunotherapy Specific
Item
subjects must not have received specific immunotherapy within the previous three months.
boolean
C0021083 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])