Clinical trial NCT01393340 (phase 2, status: completed)
Conditions: nasal polyposis, asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: omalizumab, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be at least 18 years of age, of either gender and any race.

          -  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.

        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.

          -  Subjects must be willing to give informed consent and adhere to visit schedules,
             medication restrictions, and agree to perform daily diary entries.

          -  Subjects must be free of any upper respiratory tract infection within two weeks prior
             to inclusion.

          -  Clinical laboratory tests must be within normal limits or clinically acceptable for
             the investigator.

          -  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.

          -  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.

        Exclusion Criteria:

          -  Women must not be pregnant, breast feeding, or premenarcheal.

          -  Patients younger than 18 years old.

          -  Subjects with history of systemic reactions to the study medication.

          -  Subjects with prohibited medication at screening without full wash-out period.

          -  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.

          -  Subjects with cystic fibrosis, primary ciliary's dysfunction or Kartagener's syndrome
             by history are excluded.

          -  Subjects must not have ever been diagnosed with a parasitic infection.

          -  Subjects must not have ever been diagnosed with cancer

          -  Subjects must not have a medical history of Human Immunodeficiency Virus (HIV) or
             hepatitis B or C. Testing will not be done at screening.

          -  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.

          -  Subjects must not have received specific immunotherapy within the previous three
             months.