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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

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.


Condition or disease Intervention/treatment Phase
Aspergillosis Cystic Fibrosis Drug: PC945 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: PC945
PC945 5mg once daily
Drug: PC945
PC945, nebulized




Primary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: Baseline to Day 84 ]
  2. 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 ]
  3. Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose [ Time Frame: Baseline to Day 84 ]
  4. Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose [ Time Frame: Baseline to Day 84 ]
  5. Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values [ Time Frame: Baseline to Day 84 ]
  6. Forced vital capacity (FVC) values [ Time Frame: Baseline to Day 84 ]
  7. Peak expiratory flow rate values (PEFR) [ Time Frame: Baseline to Day 84 ]
  8. Maximum expiratory flow values (MEF25-75) [ Time Frame: Baseline to Day 84 ]
  9. Breathlessness visual analogue scale rating, change over time [ Time Frame: Baseline to Day 84 ]
    Symptom severity rated from "Best ever" to "Worst possible"

  10. Cough visual analogue scale rating, change over time [ Time Frame: Baseline to Day 84 ]
    Symptom severity rated from "Best ever" to "Worst possible"

  11. 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

  12. Maximum plasma concentration [ Time Frame: Baseline to Day 84 ]
    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable

  13. 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


Secondary Outcome Measures :
  1. Change in the number of sputum A. fumigatus colony forming units (CFU) [ Time Frame: Baseline to Day 84 ]
  2. A. fumigatus status (presence or absence) in subjects with a baseline A. fumigatus-positive sputum culture [ Time Frame: Day 1 to Day 84 ]
  3. Change in sputum A. fumigatus measured by quantitative polymerase chain reaction (qPCR) [ Time Frame: Baseline to Day 84 ]
  4. Change in the serum concentration of A. fumigatus-specific immunoglobulins G (IgG) [ Time Frame: Baseline to Day 84 ]
  5. Change in serum Total immunoglobulin E (IgE) levels [ Time Frame: Baseline to Day 84 ]
  6. Change in serum Aspergillus-specific IgE levels [ Time Frame: Baseline to Day 84 ]
  7. Correlation between A. fumigatus measured by qPCR and clinical response [ Time Frame: Baseline to Day 84 ]
  8. Cystic Fibrosis Questionnaire - Revised (CFQ-R) score [ Time Frame: Baseline to Day 84 ]
  9. Sputum consistency, including presence of blood [ Time Frame: Baseline to Day 84 ]
    Categorical variable

  10. Sputum colour [ Time Frame: Baseline to Day 84 ]
    Categorical variable using standardised colour chart.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870841


Locations
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United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Northwest Lung Research Centre
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Pulmocide Ltd
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Responsible Party: Pulmocide Ltd
ClinicalTrials.gov Identifier: NCT03870841    
Other Study ID Numbers: PC_ASP_003
2018-000243-87 ( EudraCT Number )
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspergillosis
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Mycoses