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Completed

NCT Number: NCT03296917

Study Examining PrEP-001 in Subjects With Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrEP-001

Drug

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-004

Drug

A spray dried pre-gelatinized waxy maize starch powder (G-001) in the single dose nasal powder device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Secondary Efficacy Endpoint: Symptom Scores: Area Under the Curve (AUC)

    Time frame: Day -4 to Day 28

    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.

  2. Secondary Efficacy Endpoint: Symptom Scores: Duration of symptoms

    Time frame: Day -4 to Day 28

    Time (days).

  3. Secondary Efficacy Endpoint: Symptom Scores: Peak symptoms score

    Time frame: Day -4 to Day 28

    Numerical sum of all individual composite symptoms.

  4. Secondary Efficacy Endpoint: Symptom Scores: Time to peak symptoms

    Time frame: Day -4 to Day 28

    Time (days).

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

    Time frame: Day -4 to Day 28

    Time (days).

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

    Time frame: Day -4 to Day 28

    Number of subjects with viral shedding.

  7. Secondary Efficacy Endpoint: Incidence(s) of illness and infection: incidence of laboratory-confirmed Influenza illness

    Time frame: Day -4 to Day 28

    The number of subjects with laboratory-confirmed influenza infection.

  8. 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

    The number of subjects with laboratory-confirmed influenza A/Perth/16/2009 (H3N2) Virus infection.

  9. Secondary Efficacy Endpoint: Incidence(s) of illness and infection: HRV-like-illness

    Time frame: Day -4 to Day 28

    The number of subjects with HRV-like illness.

  10. Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Sub-clinical infection

    Time frame: Day -4 to Day 28

    The number of subjects with Sub-clinical illness.

  11. Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Upper respiratory tract illness

    Time frame: Day -4 to Day 28

    The number of subjects with Upper respiratory tract illness.

  12. Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Lower respiratory tract illness

    Time frame: Day -4 to Day 28

    The number of subjects with Lower respiratory tract illness.

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

    Time frame: Day -4 to Day 28

    The number of subjects with Febrile illness.

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

    Time frame: Day -4 to Day 28

    The number of subjects with Systemic illness.

  15. Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Non-sick and uninfected

    Time frame: Day -4 to Day 28

    The number of subjects Non-sick and uninfected.

  16. Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Viral replication, as measured by tissue culture assay

    Time frame: Day -4 to Day 28

    The number of subjects with viral replication.

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

    Time frame: Day -4 to Day 28

    The number of subjects with seroconversion.

  18. 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

    Viral load data supplied in Log10 Copies/mL. These values used to calculate the Area Under the Curve (AUC) for each subject.

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

    Time frame: Day -4 to Day 28

    Time (days).

  20. Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash RT-qPCR

    Time frame: Day -4 to Day 28

    The highest observed RT-qPCR viral load value.

  21. 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

    Time (days).

  22. Secondary Efficacy Endpoint: Time to resolution from peak viral shedding, as measured by nasal wash RT-qPCR.

    Time frame: Day -4 to Day 28

    Time (days).

  23. Secondary Efficacy Endpoint: Area under the curve (AUC) of viral load, as measured by nasal wash TCID50.

    Time frame: Day -4 to Day 28

    Tissue culture viral load data supplied in log10 TCID50/mL. These values used to calculate the Area Under the Curve (AUC) for each subject.

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

    Time frame: Day -4 to Day 28

    Time (days).

  25. Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash TCID50.

    Time frame: Day -4 to Day 28

    The highest observed RT-qPCR viral load value.

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

    Time frame: Day -4 to Day 28

    Time (days).

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

    Time frame: Day -4 to Day 28

    Weight (grams).

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

    Time frame: Day -4 to Day 28

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

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

    Time frame: Day -4 to Day 28

    ACQ score.

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

    Time frame: Day -4 to Day 28

    FeNO (ppb).

Other outcomes

  1. Exploratory Efficacy Analysis: Proportion (on any occasion) of subjects with Grade 2 or worse symptoms at any day post-Viral Challenge.

    Time frame: Day -14 to Day 28

    Number of subjects with Grade 2 or higher symptoms at any day post-Viral Challenge.

  2. Exploratory Efficacy Analysis: Proportion of subjects with Grade 2 or worse symptoms at each day post-Viral Challenge.

    Time frame: Day -4 to Day 28

    Number of subjects with symptoms at Grade 2 or higher, at each day post-Viral Challenge.

  3. Exploratory Efficacy Analysis: Duration of Grade 2 or worse symptoms (post-Viral Challenge).

    Time frame: Day -4 to Day 28

    Time (days).

  4. Exploratory Efficacy Analysis: Proportion of subjects with any clinical symptoms (i.e., with Grade ≥ 1) (post-Viral Challenge).

    Time frame: Day -4 to Day 28

    The proportion of subjects with symptoms grade 1 or higher.

  5. Exploratory Efficacy Analysis: Proportion of subjects with Grade ≥1 symptom score for upper respiratory tract (URT) symptoms (post-Viral Challenge).

    Time frame: Day -4 to Day 28

    The proportion of subjects with upper respiratory tract symptoms.

  6. Exploratory Efficacy Analysis: Proportion of subjects with Grade ≥1 symptom score for lower respiratory tract (LRT) symptoms (post-Viral Challenge).

    Time frame: Day -4 to Day 28

    The proportion of subjects with lower respiratory tract symptoms.

  7. Exploratory Efficacy Analysis: Proportion of subjects with Grade ≥1 symptom score for systemic symptoms (post-Viral Challenge).

    Time frame: Day -4 to Day 28

    The proportion of subjects with systemic symptoms.

  8. Exploratory Efficacy Analysis: Time to peak for each reported and any symptoms (post-Viral Challenge).

    Time frame: Day -4 to Day 28

    Time (days).

  9. Exploratory Efficacy Analysis: Proportion of subjects with pyrexia.

    Time frame: Day -4 to Day 28

    The proportion of subjects with pyrexia.

  10. Exploratory Efficacy Analysis: Duration of pyrexia.

    Time frame: Day -4 to Day 28

    Time (hours).

  11. Exploratory Efficacy Analysis: Tympanic temperature.

    Time frame: Day -4 to Day 28

    Changes in tympanic temperature over time (post Viral Challenge) (degrees Celcius)

  12. 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.

    Time frame: Day -4 to Day 28

    AUC of individual symptom scores.

  13. Exploratory Efficacy Analysis: Proportion of subjects with Lab-confirmed Clinical Symptoms of URTI.

    Time frame: Day -4 to Day 28

    The number of subjects with lab-confirmed clinical symptoms of URTI.

  14. Exploratory Efficacy Analysis: Proportion of subjects with Lab-confirmed Clinical Symptoms of LRTI.

    Time frame: Day -4 to Day 28

    The number of subjects with lab-confirmed clinical symptoms of LRTI.

  15. Exploratory Efficacy Analysis: Proportion of subjects with Lab-confirmed Clinical Symptoms of Systemic Illness (SI).

    Time frame: Day -4 to Day 28

    The number of subjects with lab-confirmed clinical symptoms of SI.

  16. Exploratory Efficacy Analysis: Overall total symptom score, Day 1 (assessment 1) to Day 8, using the 10-item symptom diary card.

    Time frame: Day -4 to Day 28

    Total symptom score.

  17. Exploratory Efficacy Analysis: Overall symptom scores (URT, LRT SVS), Day 1 (assessment 1) to Day 8, using the 10-item symptom diary card.

    Time frame: Day -4 to Day 28

    Total symptom score.

  18. Safety endpoint: Treatment-emergent Adverse Events (TEAE).

    Time frame: Day -4 to Day 28

    Incidence of treatment-emergent AEs (TEAE), overall, and by severity and causality (analysed descriptively).

  19. Safety endpoint: Clinical laboratory parameters.

    Time frame: Day -4 to Day 28

    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.

  20. Safety endpoint: Vital signs.

    Time frame: Day -4 to Day 28

    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 (%).

  21. Safety endpoint: Physical Examination.

    Time frame: Day -4 to Day 28

    Physical examination findings (analysed descriptively).

  22. Safety endpoint: Spirometry.

    Time frame: Day -4 to Day 28

    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).

  23. Safety endpoint: ECGs.

    Time frame: Day -4 to Day 28

    12-lead electrocardiogram (ECG) findings (analysed descriptively).

  24. Safety endpoint: Asthma Exacerbations (Number)

    Time frame: Day -4 to Day 28

    Number and percentage of subjects experiencing any asthma exacerbations.

  25. Safety endpoint: Duration of each asthma exacerbation

    Time frame: Day -4 to Day 28

    Time (days)

  26. Safety endpoint: Time to first asthma exacerbation

    Time frame: Day -4 to Day 28

    Time (days)

  27. Safety endpoint: Subjects requiring treatment for asthma exacerbation

    Time frame: Day -4 to Day 28

    Number of subjects requiring oral or parenteral steroids as treatment for their exacerbation.

  28. Safety endpoint: Subjects requiring hospitalisation for asthma exacerbation

    Time frame: Day -4 to Day 28

    Number of subjects requiring hospitalisation for their exacerbation.

Sponsors and collaborators

Lead sponsor

Hvivo

Industry

Collaborators

  • Prep Biopharm Limited

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2017
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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