Clinical trial NCT02367313 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: vapendavir, vapendavir, 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:

          1. Moderate and severe male and female asthma subjects aged 18 to 75 years, (inclusive)

          2. Established clinical history of Asthma for at least 1 year, and a history within the
             last 14 months (prior to screening) of asthma exacerbation due to presumed viral
             respiratory infections, which required asthma rescue medication treatment.

          3. The asthma subjects will be currently taking at least medium-dose or high-dose ICS
             defined as fluticasone at a dosage of at least >264 µg daily and may be taking other
             asthma medication preparations. The asthma subjects' medication regimen must be stable
             for at least 4 weeks before screening.

          4. Subjects will have at screening or within the last year, documented variable airway
             obstruction as indicated by an increase in FEV1 (>12%) to short acting bronchodilator,
             or positive methacholine challenge, or positive histamine challenge (PC20 <8 mg/mL).

          5. Upon presentation to the clinic with cold symptoms, subjects will be required to be
             randomized and treated within 48 hours of symptom onset and will be qualified for
             presumptive rhinovirus infection by:

               1. clinical exam and the presence of each of the following Day 1 WURSS-21 symptoms
                  at a severity of 2 or greater: runny nose, sore throat, scratchy throat.

               2. subjects must also have a minimum total symptom score on the Day 1 WURSS-21 of 20
                  points.

               3. subjects will be further qualified as presumptively infected with HRV via
                  exclusion of subjects having significant fever and exclusion of subjects testing
                  positive for influenza via Rapid Antigen Test.

        Exclusion Criteria:

          1. Subjects presenting to the clinic with a current severe asthma exacerbation will be
             excluded from randomization, as well as any subject with an additional underlying
             respiratory medical condition other than asthma such as COPD, cystic fibrosis, or
             chronic sinusitis, or any other uncontrolled clinically significant disease which
             would interfere with the assessment outcomes or subject safety.

          2. Female subjects must not be pregnant or breastfeeding. Females of childbearing
             potential must be willing to utilize a double barrier method of contraception, as
             defined in this protocol, regardless of any hormonal contraception they may be
             concomitantly receiving.

          3. Male subjects must agree to use a method of birth control defined in this protocol.

          4. The use of medications known to moderately or severely inhibit or induce cytochrome
             (CYP) 3A4 and 2C19 enzymes, or those known to be sensitive substrates (with a narrow
             therapeutic range) of these CYPs are restricted.