AsthmaPhase 2NCT03296917
Study Examining PrEP-001 in Subjects With Asthma
A Phase 2 study testing PrEP-001 and G-004 in people with Asthma, run by Hvivo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- PrEP-001 and G-004
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 11 Dec 2015to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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)
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- PrEP-001, G-004
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP-001Drug
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.
G-004Drug
A spray dried pre-gelatinized waxy maize starch powder (G-001) in the single dose nasal powder device
| Study group | Role | What they receive |
|---|---|---|
| IMP - PrEP-001 | Experimental | 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) Receives: Drug: PrEP-001 |
| Placebo - G-004 | Placebo comparator | 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). Receives: Drug: G-004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day -14 to Day 28
Secondary outcomes (30)
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.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Symptom Scores: Duration of symptoms
Time (days).
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Symptom Scores: Peak symptoms score
Numerical sum of all individual composite symptoms.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Symptom Scores: Time to peak symptoms
Time (days).
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Symptom Scores: Time to resolution from peak symptoms
Time (days).
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: viral shedding
Number of subjects with viral shedding.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: incidence of laboratory-confirmed Influenza illness
The number of subjects with laboratory-confirmed influenza infection.
Measured: Day -4 to Day 28
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.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: HRV-like-illness
The number of subjects with HRV-like illness.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Sub-clinical infection
The number of subjects with Sub-clinical illness.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Upper respiratory tract illness
The number of subjects with Upper respiratory tract illness.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Lower respiratory tract illness
The number of subjects with Lower respiratory tract illness.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Febrile illness
The number of subjects with Febrile illness.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Systemic illness
The number of subjects with Systemic illness.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Non-sick and uninfected
The number of subjects Non-sick and uninfected.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Viral replication, as measured by tissue culture assay
The number of subjects with viral replication.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Seroconversion
The number of subjects with seroconversion.
Measured: Day -4 to Day 28
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.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash RT-qPCR
Time (days).
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash RT-qPCR
The highest observed RT-qPCR viral load value.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Viral Load Parameters: Time to peak viral shedding, as measured by nasal wash RT-qPCR
Time (days).
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Time to resolution from peak viral shedding, as measured by nasal wash RT-qPCR.
Time (days).
Measured: Day -4 to Day 28
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.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash TCID50.
Time (days).
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash TCID50.
The highest observed RT-qPCR viral load value.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Time to peak viral shedding, as measured by nasal wash TCID50.
Time (days).
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Total weight of nasal discharge produced post Viral Challenge to Quarantine discharge.
Weight (grams).
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Change in lung function compared to pre-Challenge.
Peak Expiratory Flow (L/min) and FEV1 (L)
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Change in Asthma Control Questionnaire (ACQ) score compared to pre-Challenge.
ACQ score.
Measured: Day -4 to Day 28
Secondary Efficacy Endpoint: Change in Fractional exhaled nitric oxide (FeNO) compared to pre-Challenge.
FeNO (ppb).
Measured: Day -4 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start11 Dec 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvivo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prep Biopharm Limited
- Responsible party
- Sponsor
- Investigators
- John Efthimiou, Study chair, Sponsor's Representative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296917
- Sponsor's protocol ID
- PrEP-CS-002
- Status last verified
- Sep 2017
- First submitted
- 13 Jun 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03296917
- Acronym / sponsor ID
- PrEP-CS-002
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HvivoIndustry (pharma, biotech, devices)
- Collaborators
- Prep Biopharm Limited
- Study start
- 11 Dec 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMP - PrEP-001 | Experimental | Drug: PrEP-001In 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) |
| Placebo - G-004 | Placebo comparator | Drug: G-004In 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP-001A 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. | Drug | IMP - PrEP-001 |
| G-004A spray dried pre-gelatinized waxy maize starch powder (G-001) in the single dose nasal powder device | Drug | Placebo - G-004 |
Primary outcome
Primary Efficacy Endpoint: The Area Under the Curve (AUC) of total symptom score post viral challenge.
Time frame: Day -14 to Day 28
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.
30 secondary outcomes
Secondary Efficacy Endpoint: Symptom Scores: Area Under the Curve (AUC)
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Symptom Scores: Duration of symptoms
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Symptom Scores: Peak symptoms score
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Symptom Scores: Time to peak symptoms
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Symptom Scores: Time to resolution from peak symptoms
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: viral shedding
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: incidence of laboratory-confirmed Influenza illness
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: laboratory confirmed Influenza A/Perth/16/2009 (H3N2) Virus infection
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: HRV-like-illness
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Sub-clinical infection
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Upper respiratory tract illness
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Lower respiratory tract illness
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Febrile illness
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Systemic illness
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Non-sick and uninfected
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Viral replication, as measured by tissue culture assay
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Seroconversion
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Viral Load Parameters: Area under the curve (AUC) of viral load, as measured by nasopharyngeal swab RT-qPCR
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash RT-qPCR
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash RT-qPCR
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Viral Load Parameters: Time to peak viral shedding, as measured by nasal wash RT-qPCR
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Time to resolution from peak viral shedding, as measured by nasal wash RT-qPCR.
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Area under the curve (AUC) of viral load, as measured by nasal wash TCID50.
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash TCID50.
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash TCID50.
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Time to peak viral shedding, as measured by nasal wash TCID50.
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Total weight of nasal discharge produced post Viral Challenge to Quarantine discharge.
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Change in lung function compared to pre-Challenge.
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Change in Asthma Control Questionnaire (ACQ) score compared to pre-Challenge.
Time frame: Day -4 to Day 28
Secondary Efficacy Endpoint: Change in Fractional exhaled nitric oxide (FeNO) compared to pre-Challenge.
Time frame: Day -4 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Efthimiou study chair
Sponsor's Representative
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PrEP-001 and G-004 in people with Asthma, run by Hvivo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: The Area Under the Curve (AUC) of total symptom score post viral challenge. (time frame: Day -14 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.