Study Examining PrEP-001 in Subjects With Asthma

Hvivo60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Asthma

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Day -14 to Day 28

Secondary Outcomes

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.

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Symptom Scores: Duration of symptoms

Time (days).

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Symptom Scores: Peak symptoms score

Numerical sum of all individual composite symptoms.

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Symptom Scores: Time to peak symptoms

Time (days).

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Symptom Scores: Time to resolution from peak symptoms

Time (days).

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Incidence(s) of illness and infection: viral shedding

Number of subjects with viral shedding.

Data from ClinicalTrials.gov

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Time frame: 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.

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

The number of subjects with 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

The number of subjects with HRV-like illness.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Febrile illness

The number of subjects with Febrile illness.

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Systemic illness

The number of subjects with Systemic illness.

Time frame: 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.

Time frame: 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.

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Seroconversion

The number of subjects with 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

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

Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash RT-qPCR

Time (days).

Time frame: 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.

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 (days).

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 (days).

Time frame: 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.

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash TCID50.

Time (days).

Time frame: 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.

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Time to peak viral shedding, as measured by nasal wash TCID50.

Time (days).

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Total weight of nasal discharge produced post Viral Challenge to Quarantine discharge.

Weight (grams).

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Change in lung function compared to pre-Challenge.

Peak Expiratory Flow (L/min) and FEV1 (L)

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Change in Asthma Control Questionnaire (ACQ) score compared to pre-Challenge.

ACQ score.

Time frame: Day -4 to Day 28

Secondary Efficacy Endpoint: Change in Fractional exhaled nitric oxide (FeNO) compared to pre-Challenge.

FeNO (ppb).

Time frame: Day -4 to Day 28