Back to resultsStudy Examining PrEP-001 in Subjects With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PrEP-001
G-004
Sponsored by
About this trial
This is an interventional prevention trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 55 years on the day of first dosing with IMP.
- Physician diagnosed asthma for at least 6 months prior to Screening and using treatment equivalent up to and including Global Initiative for Asthma (GINA) Stage 3.
- In good health with no history of major medical conditions (other than asthma) that will interfere with subject safety, as defined by medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.
Exclusion Criteria:
- Any ex-smoker or smoker with a history of more than 10 pack-years.
- History of life-threatening asthma, Diagnosis of COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
- Any history or evidence of any clinically significant medical and psychiatric conditions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IMP - PrEP-001
Placebo - G-004
Arm Description
In Viral Challenge arm cohort: A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1). In the Safety arm's first dose cohort: A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1). Then assuming no significant safety issues with the lower dose (as determined by blinded review by the DSMB team), the Safety arm's second dose cohort will consist of: A nasal dose of 12800 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1)
In the Viral Challenge arm and each Safety Arm cohort: A nasal dose of placebo equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).
Outcomes
Primary Outcome Measures
Primary Efficacy Endpoint: The Area Under the Curve (AUC) of total symptom score post viral challenge.
AUC of total symptom scores (upper respiratory tract (URT), lower respiratory tract (LRT) and systemic viral symptoms (SVS)). Total symptom scores (from the symptom diary card) used to calculate the AUC. The primary endpoint is only being derived from the Viral Challenge arm.
Secondary Outcome Measures
Secondary Efficacy Endpoint: Symptom Scores: Area Under the Curve (AUC)
AUC of individual symptom scores (upper respiratory tract (URT), lower respiratory tract (LRT) and systemic viral symptoms (SVS)). A total symptom score is derived for each subject, separately for each assessment (symptom diary card) on each day.
Secondary Efficacy Endpoint: Symptom Scores: Duration of symptoms
Time (days).
Secondary Efficacy Endpoint: Symptom Scores: Peak symptoms score
Numerical sum of all individual composite symptoms.
Secondary Efficacy Endpoint: Symptom Scores: Time to peak symptoms
Time (days).
Secondary Efficacy Endpoint: Symptom Scores: Time to resolution from peak symptoms
Time (days).
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: viral shedding
Number of subjects with viral shedding.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: incidence of laboratory-confirmed Influenza illness
The number of subjects with laboratory-confirmed influenza infection.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: laboratory confirmed Influenza A/Perth/16/2009 (H3N2) Virus infection
The number of subjects with laboratory-confirmed influenza A/Perth/16/2009 (H3N2) Virus infection.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: HRV-like-illness
The number of subjects with HRV-like illness.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Sub-clinical infection
The number of subjects with Sub-clinical illness.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Upper respiratory tract illness
The number of subjects with Upper respiratory tract illness.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Lower respiratory tract illness
The number of subjects with Lower respiratory tract illness.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Febrile illness
The number of subjects with Febrile illness.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Systemic illness
The number of subjects with Systemic illness.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Non-sick and uninfected
The number of subjects Non-sick and uninfected.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Viral replication, as measured by tissue culture assay
The number of subjects with viral replication.
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Seroconversion
The number of subjects with seroconversion.
Secondary Efficacy Endpoint: Viral Load Parameters: Area under the curve (AUC) of viral load, as measured by nasopharyngeal swab RT-qPCR
Viral load data supplied in Log10 Copies/mL. These values used to calculate the Area Under the Curve (AUC) for each subject.
Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash RT-qPCR
Time (days).
Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash RT-qPCR
The highest observed RT-qPCR viral load value.
Secondary Efficacy Endpoint: Viral Load Parameters: Time to peak viral shedding, as measured by nasal wash RT-qPCR
Time (days).
Secondary Efficacy Endpoint: Time to resolution from peak viral shedding, as measured by nasal wash RT-qPCR.
Time (days).
Secondary Efficacy Endpoint: Area under the curve (AUC) of viral load, as measured by nasal wash TCID50.
Tissue culture viral load data supplied in log10 TCID50/mL. These values used to calculate the Area Under the Curve (AUC) for each subject.
Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash TCID50.
Time (days).
Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash TCID50.
The highest observed RT-qPCR viral load value.
Secondary Efficacy Endpoint: Time to peak viral shedding, as measured by nasal wash TCID50.
Time (days).
Secondary Efficacy Endpoint: Total weight of nasal discharge produced post Viral Challenge to Quarantine discharge.
Weight (grams).
Secondary Efficacy Endpoint: Change in lung function compared to pre-Challenge.
Peak Expiratory Flow (L/min) and FEV1 (L)
Secondary Efficacy Endpoint: Change in Asthma Control Questionnaire (ACQ) score compared to pre-Challenge.
ACQ score.
Secondary Efficacy Endpoint: Change in Fractional exhaled nitric oxide (FeNO) compared to pre-Challenge.
FeNO (ppb).
Full Information
NCT ID
NCT03296917
First Posted
June 13, 2017
Last Updated
September 25, 2017
Sponsor
Hvivo
Collaborators
Prep Biopharm Limited
1. Study Identification
Unique Protocol Identification Number
NCT03296917
Brief Title
Study Examining PrEP-001 in Subjects With Asthma
Official Title
A Phase II, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Asthmatic Subjects Subsequently Challenged With Human Rhinovirus (HRV-16)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 11, 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hvivo
Collaborators
Prep Biopharm Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase 2 study, to examine the prophylactic efficacy, safety and tolerability of PrEP-001 in asthmatics who have been infected with the human rhinovirus (HRV16) after receiving two doses of the study drug/placebo.
Detailed Description
Screening took place up to 90 days before quarantine, where volunteers were asked to complete an informed consent and undergo scheduled screening assessments to determine their eligibility.
Eligible volunteers were invited to test and record their respiratory symptoms and peak expiratory flow (PEF), medications and any adverse events in diary cards from Day -14 to Day -5.
They attended Quarantine on Day -4/-3, received the study drug/placebo intra nasally on Day -2 and Day -1 and subsequently challenged with HRV16 on Day 0. Randomisation to receive study drug/placebo was 1:1.
Volunteers remained in the quarantine unit for 8 days after inoculation.
PEF self-testing continued from Day 9 to Day 28.
On Day 20 (±3 days) and Day 28 (±5 days), volunteers attended follow up visits where they were assessed by a study physician for well-being, on-going symptoms and adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMP - PrEP-001
Arm Type
Experimental
Arm Description
In Viral Challenge arm cohort:
A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).
In the Safety arm's first dose cohort:
A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).
Then assuming no significant safety issues with the lower dose (as determined by blinded review by the DSMB team), the Safety arm's second dose cohort will consist of:
A nasal dose of 12800 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1)
Arm Title
Placebo - G-004
Arm Type
Placebo Comparator
Arm Description
In the Viral Challenge arm and each Safety Arm cohort:
A nasal dose of placebo equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).
Intervention Type
Drug
Intervention Name(s)
PrEP-001
Intervention Description
A spray dried powder for intranasal administration formulated from an aqueous mixture of pre-gelatinized waxy maize starch and the drug substance delivered using a single dose nasal powder device.
Intervention Type
Drug
Intervention Name(s)
G-004
Intervention Description
A spray dried pre-gelatinized waxy maize starch powder (G-001) in the single dose nasal powder device
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint: The Area Under the Curve (AUC) of total symptom score post viral challenge.
Description
AUC of total symptom scores (upper respiratory tract (URT), lower respiratory tract (LRT) and systemic viral symptoms (SVS)). Total symptom scores (from the symptom diary card) used to calculate the AUC. The primary endpoint is only being derived from the Viral Challenge arm.
Time Frame
Day -14 to Day 28
Secondary Outcome Measure Information:
Title
Secondary Efficacy Endpoint: Symptom Scores: Area Under the Curve (AUC)
Description
AUC of individual symptom scores (upper respiratory tract (URT), lower respiratory tract (LRT) and systemic viral symptoms (SVS)). A total symptom score is derived for each subject, separately for each assessment (symptom diary card) on each day.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Symptom Scores: Duration of symptoms
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Symptom Scores: Peak symptoms score
Description
Numerical sum of all individual composite symptoms.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Symptom Scores: Time to peak symptoms
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Symptom Scores: Time to resolution from peak symptoms
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: viral shedding
Description
Number of subjects with viral shedding.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: incidence of laboratory-confirmed Influenza illness
Description
The number of subjects with laboratory-confirmed influenza infection.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: laboratory confirmed Influenza A/Perth/16/2009 (H3N2) Virus infection
Description
The number of subjects with laboratory-confirmed influenza A/Perth/16/2009 (H3N2) Virus infection.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: HRV-like-illness
Description
The number of subjects with HRV-like illness.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Sub-clinical infection
Description
The number of subjects with Sub-clinical illness.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Upper respiratory tract illness
Description
The number of subjects with Upper respiratory tract illness.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Lower respiratory tract illness
Description
The number of subjects with Lower respiratory tract illness.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Febrile illness
Description
The number of subjects with Febrile illness.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Systemic illness
Description
The number of subjects with Systemic illness.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Non-sick and uninfected
Description
The number of subjects Non-sick and uninfected.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Viral replication, as measured by tissue culture assay
Description
The number of subjects with viral replication.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Seroconversion
Description
The number of subjects with seroconversion.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Viral Load Parameters: Area under the curve (AUC) of viral load, as measured by nasopharyngeal swab RT-qPCR
Description
Viral load data supplied in Log10 Copies/mL. These values used to calculate the Area Under the Curve (AUC) for each subject.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash RT-qPCR
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash RT-qPCR
Description
The highest observed RT-qPCR viral load value.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Viral Load Parameters: Time to peak viral shedding, as measured by nasal wash RT-qPCR
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Time to resolution from peak viral shedding, as measured by nasal wash RT-qPCR.
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Area under the curve (AUC) of viral load, as measured by nasal wash TCID50.
Description
Tissue culture viral load data supplied in log10 TCID50/mL. These values used to calculate the Area Under the Curve (AUC) for each subject.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash TCID50.
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash TCID50.
Description
The highest observed RT-qPCR viral load value.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Time to peak viral shedding, as measured by nasal wash TCID50.
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Total weight of nasal discharge produced post Viral Challenge to Quarantine discharge.
Description
Weight (grams).
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Change in lung function compared to pre-Challenge.
Description
Peak Expiratory Flow (L/min) and FEV1 (L)
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Change in Asthma Control Questionnaire (ACQ) score compared to pre-Challenge.
Description
ACQ score.
Time Frame
Day -4 to Day 28
Title
Secondary Efficacy Endpoint: Change in Fractional exhaled nitric oxide (FeNO) compared to pre-Challenge.
Description
FeNO (ppb).
Time Frame
Day -4 to Day 28
Other Pre-specified Outcome Measures:
Title
Exploratory Efficacy Analysis: Proportion (on any occasion) of subjects with Grade 2 or worse symptoms at any day post-Viral Challenge.
Description
Number of subjects with Grade 2 or higher symptoms at any day post-Viral Challenge.
Time Frame
Day -14 to Day 28
Title
Exploratory Efficacy Analysis: Proportion of subjects with Grade 2 or worse symptoms at each day post-Viral Challenge.
Description
Number of subjects with symptoms at Grade 2 or higher, at each day post-Viral Challenge.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Duration of Grade 2 or worse symptoms (post-Viral Challenge).
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Proportion of subjects with any clinical symptoms (i.e., with Grade ≥ 1) (post-Viral Challenge).
Description
The proportion of subjects with symptoms grade 1 or higher.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Proportion of subjects with Grade ≥1 symptom score for upper respiratory tract (URT) symptoms (post-Viral Challenge).
Description
The proportion of subjects with upper respiratory tract symptoms.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Proportion of subjects with Grade ≥1 symptom score for lower respiratory tract (LRT) symptoms (post-Viral Challenge).
Description
The proportion of subjects with lower respiratory tract symptoms.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Proportion of subjects with Grade ≥1 symptom score for systemic symptoms (post-Viral Challenge).
Description
The proportion of subjects with systemic symptoms.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Time to peak for each reported and any symptoms (post-Viral Challenge).
Description
Time (days).
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Proportion of subjects with pyrexia.
Description
The proportion of subjects with pyrexia.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Duration of pyrexia.
Description
Time (hours).
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Tympanic temperature.
Description
Changes in tympanic temperature over time (post Viral Challenge) (degrees Celcius)
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Area under the curve (AUC) of symptom scores using the 13-item symptom diary card (total, URT, LRT and SVS), Day 1 (assessment 1) to Day 8.
Description
AUC of individual symptom scores.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Proportion of subjects with Lab-confirmed Clinical Symptoms of URTI.
Description
The number of subjects with lab-confirmed clinical symptoms of URTI.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Proportion of subjects with Lab-confirmed Clinical Symptoms of LRTI.
Description
The number of subjects with lab-confirmed clinical symptoms of LRTI.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Proportion of subjects with Lab-confirmed Clinical Symptoms of Systemic Illness (SI).
Description
The number of subjects with lab-confirmed clinical symptoms of SI.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Overall total symptom score, Day 1 (assessment 1) to Day 8, using the 10-item symptom diary card.
Description
Total symptom score.
Time Frame
Day -4 to Day 28
Title
Exploratory Efficacy Analysis: Overall symptom scores (URT, LRT SVS), Day 1 (assessment 1) to Day 8, using the 10-item symptom diary card.
Description
Total symptom score.
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Treatment-emergent Adverse Events (TEAE).
Description
Incidence of treatment-emergent AEs (TEAE), overall, and by severity and causality (analysed descriptively).
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Clinical laboratory parameters.
Description
Absolute values and change from baseline in routine clinical laboratory parameters by timepoint (analysed descriptively). Includes haematology, biochemistry, coagulation, cardiac enzymes, thyroid function tests and urinalysis parameters.
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Vital signs.
Description
Absolute values and change from baseline in vital signs parameters by timepoint (analysed descriptively); systolic blood pressure (SBP) (mmHg), diastolic blood pressure (DBP) (mmHg), respiratory rate (RR) (breaths per minute), heart rate (HR) (beats per minute) and SpO2 (%).
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Physical Examination.
Description
Physical examination findings (analysed descriptively).
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Spirometry.
Description
Absolute and changes from baseline for FEV1 [absolute] (L), FEV1 [% predicted] (%), FVC [absolute] (L), FVC [% predicted] (%), FEV1/FVC ratio [absolute], FEV1/FVC ratio [% predicted] (%), maximum mid expiratory flow (MMEF) [absolute] (L/sec) and MMEF [% predicted]). The lung function parameter Peak Expiratory Flow [L/min] will also be summarised (analysed descriptively).
Time Frame
Day -4 to Day 28
Title
Safety endpoint: ECGs.
Description
12-lead electrocardiogram (ECG) findings (analysed descriptively).
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Asthma Exacerbations (Number)
Description
Number and percentage of subjects experiencing any asthma exacerbations.
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Duration of each asthma exacerbation
Description
Time (days)
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Time to first asthma exacerbation
Description
Time (days)
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Subjects requiring treatment for asthma exacerbation
Description
Number of subjects requiring oral or parenteral steroids as treatment for their exacerbation.
Time Frame
Day -4 to Day 28
Title
Safety endpoint: Subjects requiring hospitalisation for asthma exacerbation
Description
Number of subjects requiring hospitalisation for their exacerbation.
Time Frame
Day -4 to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 55 years on the day of first dosing with IMP.
Physician diagnosed asthma for at least 6 months prior to Screening and using treatment equivalent up to and including Global Initiative for Asthma (GINA) Stage 3.
In good health with no history of major medical conditions (other than asthma) that will interfere with subject safety, as defined by medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.
Exclusion Criteria:
Any ex-smoker or smoker with a history of more than 10 pack-years.
History of life-threatening asthma, Diagnosis of COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
Any history or evidence of any clinically significant medical and psychiatric conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Efthimiou
Organizational Affiliation
Sponsor's Representative
Official's Role
Study Chair
12. IPD Sharing Statement
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Study Examining PrEP-001 in Subjects With Asthma
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