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The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870841
Recruitment Status : Terminated (The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.)
First Posted : March 12, 2019
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Pulmocide Ltd

Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE March 12, 2019
Last Update Posted Date June 12, 2020
Actual Study Start Date  ICMJE April 3, 2019
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Adverse events (AEs) [ Time Frame: Baseline to Day 84 ]
  • Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose [ Time Frame: Baseline to Day 84 ]
  • Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose [ Time Frame: Baseline to Day 84 ]
  • Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose [ Time Frame: Baseline to Day 84 ]
  • Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values [ Time Frame: Baseline to Day 84 ]
  • Forced vital capacity (FVC) values [ Time Frame: Baseline to Day 84 ]
  • Peak expiratory flow rate values (PEFR) [ Time Frame: Baseline to Day 84 ]
  • Maximum expiratory flow values (MEF25-75) [ Time Frame: Baseline to Day 84 ]
  • Breathlessness visual analogue scale rating, change over time [ Time Frame: Baseline to Day 84 ]
    Symptom severity rated from "Best ever" to "Worst possible"
  • Cough visual analogue scale rating, change over time [ Time Frame: Baseline to Day 84 ]
    Symptom severity rated from "Best ever" to "Worst possible"
  • Area under the curve from time 0 to 2 h post-dose (AUC0-2) [ Time Frame: Baseline to Day 84 ]
    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable
  • Maximum plasma concentration [ Time Frame: Baseline to Day 84 ]
    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable
  • Concentration at the end of the dosage interval (Ctrough) [ Time Frame: Baseline to Day 84 ]
    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Change in the number of sputum A. fumigatus colony forming units (CFU) [ Time Frame: Baseline to Day 84 ]
  • A. fumigatus status (presence or absence) in subjects with a baseline A. fumigatus-positive sputum culture [ Time Frame: Day 1 to Day 84 ]
  • Change in sputum A. fumigatus measured by quantitative polymerase chain reaction (qPCR) [ Time Frame: Baseline to Day 84 ]
  • Change in the serum concentration of A. fumigatus-specific immunoglobulins G (IgG) [ Time Frame: Baseline to Day 84 ]
  • Change in serum Total immunoglobulin E (IgE) levels [ Time Frame: Baseline to Day 84 ]
  • Change in serum Aspergillus-specific IgE levels [ Time Frame: Baseline to Day 84 ]
  • Correlation between A. fumigatus measured by qPCR and clinical response [ Time Frame: Baseline to Day 84 ]
  • Cystic Fibrosis Questionnaire - Revised (CFQ-R) score [ Time Frame: Baseline to Day 84 ]
  • Sputum consistency, including presence of blood [ Time Frame: Baseline to Day 84 ]
    Categorical variable
  • Sputum colour [ Time Frame: Baseline to Day 84 ]
    Categorical variable using standardised colour chart.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis
Official Title  ICMJE An Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus Infection
Brief Summary

This study tests the effects of an experimental drug PC945 in people with cystic fibrosis whose lungs are infected by the fungus Aspergillus fumigatus.

PC945 may be useful in treating patients infected with Aspergillus fumigatus as, unlike the usual treatments, it is inhaled into the lung and has been designed to stay there and treat the infection. Participants will continue to be treated with their usual cystic fibrosis treatment and will also receive PC945. The amount of fungus in the patients' phlegm will be measured over the course of the study. The study will take place at multiple sites in UK and will include approximately 18 participants. The maximum study duration will be about 16 weeks.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aspergillosis
  • Cystic Fibrosis
Intervention  ICMJE Drug: PC945
PC945, nebulized
Study Arms  ICMJE Experimental: PC945
PC945 5mg once daily
Intervention: Drug: PC945
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 10, 2020)
4
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2019)
18
Actual Study Completion Date  ICMJE June 1, 2020
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject must be male or female, aged 18 years inclusive or older (at the time of consent).
  2. Subject must be willing and able to adhere to the restrictions and prohibitions required by this protocol.
  3. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and that they are willing to participate.
  4. A confirmed diagnosis of CF by standard criteria.
  5. Subject is able to produce sputum.
  6. A history of persistently positive A. fumigatus sputum cultures from at least 2 sputum samples in the last year, the most recent of which must have been within the last 6 months.
  7. Subject must have a positive sputum fungal culture at screening with one or more colonies of A. fumigatus detected using a modified standard approach.

Exclusion Criteria:

  1. Any other disease or condition, which in the Investigator's medical opinion would preclude the subject's participation in a clinical trial.
  2. Is taking inhaled amphotericin B or has taken it within 7 weeks of Day 1.
  3. Is taking systemic steroid treatment or has taken it within 4 weeks of Day 1. Subjects considered to be stable on a systemic steroid dose of <15 mg for at least a month will not be excluded.
  4. Is taking systemic antifungal treatment (intravenous, oral or inhaled) or has received antifungal therapy (intravenous, oral or inhaled) within 6 weeks of Day 1.
  5. If female, the subject is pregnant (e.g., has a positive serum β human chorionic gonadotropin (β-hCG) at screening or a positive urinary pregnancy test pre-dose on Day 1), lactating or breast feeding.
  6. Any respiratory exacerbation within 2 weeks of the start of the study.
  7. Any upper respiratory tract infection or signs or symptoms thereof within 2 weeks prior to dosing.
  8. Positive culture for Mycobacterium abscessus within 12 months before screening or between screening and baseline, or currently receiving treatment for Mycobacterium abscessus.
  9. Has chronic, active hepatitis or a positive hepatitis B surface antigen or positive hepatitis C antibody result at screening.
  10. Is taking antiretroviral protease inhibitor therapy.
  11. Allergy to any of the active or inactive ingredients in the study medication.
  12. History of drug (or other) allergy or intolerance that, in the opinion of the Investigator or Pulmocide Medical Monitor, would contraindicate their participation.
  13. Clinically significant haemoptysis (>200 mL per episode) within 90 days before screening.
  14. Subject is mentally or legally incapacitated. 19 July 2018 CONFIDENTIAL Page 27 of 58 Pulmocide Ltd Clinical Protocol PC_ASP_003
  15. Subject is employed or is a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site, or any contract research organisation involved in the study.
  16. Any other reason that the Investigator considers makes the subject unsuitable to participate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03870841
Other Study ID Numbers  ICMJE PC_ASP_003
2018-000243-87 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pulmocide Ltd
Study Sponsor  ICMJE Pulmocide Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pulmocide Ltd
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP