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AsthmaPhase 2NCT03745196

The Effect of PC945 on Aspergillus or Candida Lung Infections in Patients With Asthma or Chronic Respiratory Diseases

A Phase 2 study testing PC945 in people with Asthma and Respiratory Candidiasis, run by Pulmocide Ltd at 4 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study tests the effects of an experimental drug PC945 in people with asthma or other chronic respiratory diseases whose lungs are infected by Aspergillus fungi and Candida yeasts. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PC945
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
4 sitesUnited Kingdom
Study dates
15 Nov 2018to 1 Jun 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be male or female, aged 18 years (inclusive) or older (at the time of consent).
  • Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and is willing to participate.
  • Subject's diagnosis of moderate to severe asthma (GINA Step 3 or 4) made by a respiratory physician and treated with an inhaled steroid or other chronic respiratory disease.
  • For subjects with asthma, the diagnosis of asthma must be supported either by:
  • i. Historical evidence of:
  • 1. Increased airway hyper-responsiveness (methacholine PC20 <8 mg/ml).
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  • or
  • 2. Airflow obstruction (FEV1/FVC ratio of less than 70%) and short-term variations in FEV1 (>12%).
  • or
  • ii. Bronchodilator reversibility ≥12% or ≥200 mL improvement in FEV1 post bronchodilator after administration of a short-acting beta agonist at screening.
  • OR
  • Subjects with other chronic respiratory disease (such as COPD or bronchiectasis) susceptible to fungal bronchitis.
  • Subject must have a positive sputum fungal culture with one or more colonies of A. fumigatus complex / A. niger complex or 200 or more colonies of yeast measured using a modified standard approach on one occasion obtained within the 28-day screening period.
  • Subject must be able to produce a spontaneous sputum sample.

Who cannot join

  • Subjects who have received more than 2 weeks of intravenous (IV), oral or inhaled antifungal therapy within 6 months prior to Visit 3 or any antifungal therapy (IV, oral or inhaled) within 2 months of Visit 3.
  • Subjects taking medication that could significantly increase the risks of AEs with triazoles.
  • Subjects who are receiving antiretroviral protease inhibitors.
  • Clinical or laboratory evidence of bacterial bronchitis at the point of screening.
  • Subjects who have used an experimental medical device or received an experimental drug within 3 months or within a period less than five times the experimental drug's half-life, whichever is longer, before the first dose of the study drug is scheduled.
  • Clinically significant screening abnormalities (including, but not limited to, vital signs, ECG, laboratory tests, physical examination and spirometry) that, in the Investigator's opinion, exclude the subject from participation in the study.
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  • Positive test at screening for hepatitis B virus infection, or antibodies to hepatitis C virus.
  • If female, the subject is pregnant (e.g. has a positive serum β human chorionic gonadotropin at screening or a positive urinary pregnancy test pre-dose on Day 1), lactating or breast feeding.
  • Subject is an employee or a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site, or any contract research organisation involved in the study.
  • Any other reason that the Investigator considers makes the subject unsuitable to participate.

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

  • Glenfield Hospital

    Leicester, LE3 9QP

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Royal Brompton Hospital

    London, SW3 6NP

  • Northwest Lung Research Centre

    Manchester, M23 9LT

Other trials in United Kingdom

About this study

Official title: A Double-blind, Placebo-controlled Study to Assess the Effects of Inhaled PC945 in the Treatment of Culture-positive Aspergillus or Candida Fungal Bronchitis in Subjects With Moderate to Severe Asthma or Other Chronic Respiratory Diseases.

This study tests the effects of an experimental drug PC945 in people with asthma or other chronic respiratory diseases whose lungs are infected by Aspergillus fungi and Candida yeasts.

PC945 may be useful in treating patients infected with Aspergillus 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 receive their usual treatment for their chronic respiratory disease. Half of the participants will receive PC945 and half will receive a placebo. The amount of fungus and yeast 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 46 participants. The maximum study duration will be about 16 weeks.

Being tested
PC945, Placebo
Medical subject headings
Asthma, Pulmonary Disease, Chronic Obstructive, Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PC945Drug

    Study drug under investigation

  • PlaceboDrug

    Placebo control

Study groups in NCT03745196
Study groupRoleWhat they receive
PC945ExperimentalPC945 5mg once-daily, nebulized
Receives: Drug: PC945
PlaceboPlacebo comparatorPlacebo, nebulized
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence or absence of Aspergillus fumigatus (A. fumigatus) complex / Aspergillus niger (A. niger) complex colonies on sputum culture

    This is a binary endpoint

    Measured: Baseline to Day 32-35

  2. Reduction in the numbed of colonies of Candida species (spp) on sputum culture

    Substantial reduction in colony forming unit (CFU) count by at least 50%

    Measured: Baseline to Day 32-35

Secondary outcomes (29)

  1. Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values

    Measured: Baseline to Day 84

  2. Forced vital capacity (FVC) values

    Measured: Baseline to Day 84

  3. The number of sputum A. fumigatus complex / A. niger complex CFUs in fungal culture

    Measured: Baseline to Day 84

  4. Sputum A. fumigatus measured by quantitative polymerase chain reaction (qPCR)

    Measured: Baseline to Day 84

  5. Spontaneous sputum weight (24-hour collection)

    Measured: Baseline to Day 84

  6. The number of sputum Candida spp. CFUs in fungal culture

    Measured: Baseline to Day 84

  7. C. albicans measured by qPCR in sputum

    Measured: Baseline to Day 84

  8. The concentration of A. fumigatus-specific immunoglobulin G (IgG) as measured in serum

    Measured: Baseline to Day 84

  9. Serum Total immunoglobulin E (IgE) levels

    Measured: Baseline to Day 84

  10. A. fumigatus-specific IgE levels

    Measured: Baseline to Day 84

  11. Change in Asthma control questionnaire - 6 item [ACQ6] (Total score) in asthma patients only

    Measured: Baseline to Day 84

  12. Change in Asthma Quality of Life Questionnaire - Juniper [AQLQ-J] (Total score) in asthma patients only

    Measured: Baseline to Day 84

  13. Change in St George's Respiratory Questionnaire [SGRQ] (Total score)

    Measured: Baseline to Day 84

  14. Change in Leicester Cough Questionnaire (Total score)

    Measured: Baseline to Day 84

  15. Breathlessness visual analogue scale rating, change over time

    Symptom severity rated from "Best ever" to "Worst possible"

    Measured: Baseline to Day 84

  16. Correlation between A. fumigatus measured by qPCR and clinical response

    Measured: Baseline to Day 84

  17. Correlation between Candida albicans measured by qPCR and clinical response

    Measured: Baseline to Day 84

  18. Area undertake curve from time 0 to 2h post dose (AUC(0-2))

    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable

    Measured: Baseline to Day 84

  19. Last quantifiable plasma concentration (Ct)

    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable

    Measured: Baseline to Day 84

  20. maximum observed concentration (Cmax)

    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable

    Measured: Baseline to Day 84

  21. concentration at the end of the dosage interval (Ctrough)

    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable

    Measured: Baseline to Day 84

  22. Adverse events (AEs) incidence (safety and tolerability)

    Measured: Baseline to Day 84

  23. Twelve-lead electrocardiogram (ECG) (Safety parameter)

    including QT interval corrected for Bazetts formula, QT interval, QRS Interval, PR Interval and ventricular rate).

    Measured: Baseline to Day 84

  24. Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose

    Measured: Baseline to Day 84

  25. Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose

    Measured: Baseline to Day 84

  26. Change in peak expiratory flow rate [PEFR]

    Measured: Baseline to Day 84

  27. Antibiotic use

    Measured: Baseline to Day 84

  28. Sputum characteristics - consistency and presence of blood (fresh morning sputum samples)

    Measured: Baseline to Day 84

  29. Sputum colour (fresh morning sputum samples)

    Measured: Baseline to Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2018
  2. Study start15 Nov 2018
  3. Primary completion1 Jun 2020
  4. Study completion1 Jun 2020

Why it stopped: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03745196
Sponsor's protocol ID
PC_ASP_004
Other IDs
2018-000244-26, 2018
Status last verified
Jun 2020
First submitted
24 Oct 2018
Last updated
12 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PC945 in people with Asthma and Respiratory Candidiasis, run by Pulmocide Ltd at 4 sites in United Kingdom.

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 14 inclusion and 10 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: stopped early, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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 was stopped early (reason given: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.). Results are not available in the source record.

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?

Presence or absence of Aspergillus fumigatus (A. fumigatus) complex / Aspergillus niger (A. niger) complex colonies on sputum culture (time frame: Baseline to Day 32-35). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03745196.

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 12 Jun 2020.

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