Clinical trial: The Effect of PC945 on Aspergillus or Candida Lung Infections in Patients With Asthma or Chronic Respiratory Diseases (NCT03745196)

Eligibility criteria:
Inclusion Criteria:

          1. Subject must be male or female, aged 18 years (inclusive) or older (at the time of
             consent).

          2. 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.

          3. 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.

               1. 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).

                         -  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

               2. Subjects with other chronic respiratory disease (such as COPD or bronchiectasis)
                  susceptible to fungal bronchitis.

          4. 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.

          5. Subject must be able to produce a spontaneous sputum sample.

        Exclusion Criteria:

          1. 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.

          2. Subjects taking medication that could significantly increase the risks of AEs with
             triazoles.

          3. Subjects who are receiving antiretroviral protease inhibitors.

          4. Clinical or laboratory evidence of bacterial bronchitis at the point of screening.

          5. 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.

          6. 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.

          7. Positive test at screening for hepatitis B virus infection, or antibodies to hepatitis
             C virus.

          8. 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.

          9. 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.

         10. Any other reason that the Investigator considers makes the subject unsuitable to
             participate.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Entailment