Asthma control following presumptive human rhinovirus (HRV) infection in moderate and severe asthma subjects, as measured by the Asthma Control Questionnaire (ACQ-6).
Conditions
Interventions
Product Name: Vapendavir 132 mg capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Vapendavir
CAS Number: 439085-51-5
Current Sponsor code: BTA798
Concentration unit: mg milligram(s)
Con
Sponsors
Biota Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects, aged 18-75 years inclusive, with an established clinical history of asthma for at least one year in accordance with the definitions described by the GINA guidelines (GINA 20121 or the National Asthma Education and Prevention NAEP Diagnosis Guidelines 20072); 2. History within the previous 14 months (prior to screening) of asthma worsening or exacerbation due to presumed viral respiratory infection which required asthma rescue medication treatment; 3. Subject has moderate or severe asthma defined by their current medication regimen of taking at least a medium-dose or high-dose inhaled corticosteroid (ICS) defined as fluticasone at a dosage of at least >264 mcg daily (or equivalent dose for other inhaled ICS). The subject’s asthma medication regimen has been stable for at least 4 weeks prior to screening and for at least 2 weeks prior to Study Day 1; 4. Subject has at screening, or within the prior 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 =65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Positive result for influenza rapid-antigen test performed on Study Day 1; 2. A fever on Day 1 of 100.4°F (38°C) or greater; 3. Subject presents at clinic on Study Day 1 with severe asthma exacerbation defined as requiring immediate treatment with systemic corticosteroids or increased doses of inhaled corticosteroids; 4. Use of systemic steroids within 30 days before Study Day 1; 5. Current use of theophylline at Screening or within 4 days of Study Day 1 and any use throughout the duration of the study; 6. Subjects with evidence of a lower respiratory infection at Study Day 1, and/or a history or current evidence of chronic obstructive airways disease, cystic fibrosis, or chronic sinusitis; 7. A medical history or current clinical evidence of significant hematological, gastrointestinal, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event (including uncontrolled hypertension as determined by the Investigator), or any clinical condition, that may in the opinion of the Investigator or Medical Monitor, impact on the subject’s ability to participate in the study, the subject’s safety, or on the study results; 8. History of adverse reaction or hypersensitivity to capsid binders, or history of significant seasonal allergy within the last 3 years that in the opinion of the investigator would significantly interfere with the evaluation of asthma control or diagnosis of presumptive HRV infection; 9. Clinical laboratory values at screening for neutrophils which reflect grade 2 or higher reductions from normal range, or AST or ALT results which reflect grade 2 or higher elevations per the Common Terminology Criteria for Adverse Events (CTCAE). Screening hemoglobin value reductions of >2 gm/dL below Lower Limit of Normal (LLN). Subjects with other clinical laboratory abnormalities outside normal reference ranges will be considered for inclusion, if in the opinion of the investigator or Medical Monitor the abnormalities are not clinically significant, and will not jeopardize the safety of the subject or the validity of the study; 10. Use of cold preparations, nasal lavage preparations or sprays, or prescription or over-the-counter nasal decongestants within the 24 hours preceding completion of the Day 1 WURSS-21 and randomization and during the study. Episodic use of over-the-counter anti-cholinergics is excluded within the 24 hours preceding completion of the Day 1 WURSS-21 and randomization and during the study. Use of nasal anti-histamines is excluded for 3 days prior to randomization and during the study. Use of the anti-histamines acrivastine, brompheniramine, chorpheniramine, dimenhydrinate, and doxylamine are excluded prior to randomization on Day 1 (short-acting for 1 week and long-acting for 2 weeks) and during the study. Note: The use of new generation antihistamines, e.g. loratadine, cetirizine, desloratadine, fexofenadine, and levocetirizine, and nasal steroid preparations is allowed, if use is stable for 7 days prior to Study Day 1 and continues in a stable regimen throughout the study. Acetaminophen and NSAID use is allowed. 11. Current (at screening and Study Day 1) abuse of alcohol or any use of illicit drugs, or history of alcohol or illicit drug abuse within the preceding 2 years. Any use of marijuana within 48 hours of Day 1 and at any time during the study, unless being used for a prescribed medical reason where the medical reason itself is not exclusionary; 12. A positive p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of vapendavir on asthma control following HRV infection, as measured by the Asthma Control Questionnaire (ACQ-6).;Secondary Objective: - To assess the safety and tolerability of vapendavir - To assess the effect of vapendavir on symptoms of human rhinovirus infection as measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21), prevention of asthma exacerbations, virology outcomes including resistance monitoring, and lung function tests. Exploratory Objective: - To compare bilateral nasopharyngeal sampling to total blown mucus sampling for HRV detection by PCR and RVP testing methodologies.;Primary end point(s): Change from baseline to Study Day 14 in ACQ-6 total score. ;Timepoint(s) of evaluation of this end point: Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Proportion of subjects with a moderate or severe asthma exacerbation during the interval of Study Days 1-14 2) Proportion of subjects with a severe asthma exacerbation during the interval of Study Days 1-14 3) Change from baseline (Day 1) to Study Day 7, to Study Day 21, or to Study Day 28 in ACQ-6 total score 4) Proportion of subjects with at least a 0.5 point reduction in ACQ-6 score from baseline (Day 1) over the 28 days of the study 5) Proportion of subjects with at least a 0.5 point increase in ACQ-6 score from baseline (Day 1) over the 28 days of the study 6) Proportion of subjects with a post-day 1 ACQ-6 score of 10% from Day 1 level at any time during Days 1-14, and during Days 1-28 17) Proportion of patients with a % FVC decline of > 10% from Day 1 level at any time during Days 1-14 and during Days 1-28 18) Proportion of patients with a % FEV1 decline of > 10% from Day 1 level at any time during Days 1-14, and during Days 1-28 19) Proportion of patients with a % FEV1 decline of > 10% from Day 1 level at any time during Days 1-14 and during Days 1-28 ;Timepoint(s) of evaluation of this end point: 1) Study Days 1-14. 2) Study Days 1-14. 3) Study Days 7, 21 and 28 4) Study Days 1-28. 5) Study Days 1-28. 6) Post-day 1. 7) Study Day 1 to 14. 8) Study Day 1 to 14. 9) Study Days 1 to 14. 10) Study Days 1 to 14. 11) Peak infection days 2-4, 3-5, and 2-7 12) Time to alleviation (hours). 13) Study Days 1-14. 14) Study Days 1-14. 15) Study Days 1-14. 16) Study Days 1-14 and 1-28. 17) Study Days 1-14 and 1-28. 18) Study Days 1-14 and 1-28. 19) Study Days 1-14 and 1-28. | — |
Countries
Bulgaria, Czech Republic, Georgia, Poland, United States
Contacts
Public ContactVP, Clinical Development
Biota Pharmaceuticals, Inc.
Outcome results
None listed