Clinical trial: A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough (NCT03979638)

Eligibility criteria:
Inclusion Criteria:

          -  Unexplained or refractory chronic cough for at least one year

          -  Chest radiograph or CT thorax within the last 60 months not demonstrating any
             abnormality considered to be significantly contributing to the chronic cough

          -  Cough count of ≥ 10 per hour (Awake Cough Count) at Screening

          -  Score of ≥ 40mm on the Cough Severity VAS at Screening

          -  Women of child-bearing potential must have a negative serum pregnancy test at
             Screening

          -  Women of child-bearing potential must use a highly effective contraception method from
             Screening through the Follow-Up Visit

          -  Male subjects and their partners of child-bearing potential must use 2 methods of
             acceptable birth control

        Exclusion Criteria:

          -  Current smoker or individuals who have given up smoking within the past 6 months, or
             those with >20 pack-year smoking history

          -  Diagnosis of COPD, bronchiectasis, idiopathic pulmonary fibrosis

          -  Treatment with an ACE-inhibitor as the potential cause of a subject's cough, or
             requiring treatment with an ACE-inhibitor during the study, or within 12 weeks prior
             to the Screening Visit

          -  FEV1/FVC < 60%

          -  History of upper respiratory tract infection or recent significant change in pulmonary
             status within 4 weeks of the Baseline Visit

          -  History of concurrent malignancy or recurrence of malignancy within 2 years prior to
             Screening

          -  History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years

          -  Clinically significant abnormal electrocardiogram (ECG) or laboratory tests at
             Screening

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with trial participation or
             investigational product administration or may interfere with the interpretation of
             trial results
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.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea.  Other medical conditions include hypertension and osteoarthritis.  The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs.  He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs.  Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled  pulmonary fibrosis that is most predominant in the lower lobes, characterized  by the presence of asbestos bodies (golden-brown beaded rods with translucent centers).

Patient description (patient's own words): I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there.

Does the patient match the trial criteria? Contradiction