Clinical trial: Pilot of Zinc Acetate to Improve Chronic Cough (NCT03135522)

Eligibility criteria:
Inclusion Criteria:

          -  No upper or lower respiratory infection within 4 weeks

          -  Either

               -  Negative evaluation for:

                    -  Asthma; no symptoms of disease or no evidence of asthma based on spirometry
                       and/or methacholine challenge test

                    -  GERD: no symptoms of acid reflux disease or negative potential of hydrogen
                       (pH) probe

                    -  Rhinosinusitis/upper airway cough

        Or

          -  Cough persists despite treatment for the following:

               -  Asthma -treated for at least 8 weeks with at least medium dose inhaled
                  corticosteroids or with oral corticosteroids

               -  GERD - treated for at least 8 weeks with either a proton pump inhibitor (PPI) or
                  H2 blocker

               -  Upper airway disease, postnasal drip or sinusitis - treated for at least 8 weeks
                  with nasal steroids, antihistamines or both.

                    -  Non-smoker; defined as

          -  no smoking of any substance (e.g., tobacco, e-cigarette, marijuana) in the past 6
             months, and

          -  less than 20 pack-year smoking history

               -  Chest x-ray or CT scan in the past 12 months; negative for parenchymal lung
                  diseases (such as interstitial lung disease, idiopathic pulmonary fibrosis,
                  pneumonia, or TB) and negative for lung cancer

               -  Overall Cough Visual Analog Scale (Cough-VAS) score of 30 or higher

               -  Willing to halt use of zinc supplements or multivitamins containing zinc for the
                  duration of the study

               -  Provide written informed consent

        Exclusion Criteria:

          -  Marijuana use (smoking or ingestion of marijuana) in the past 6 months

          -  Use of ACE inhibitor currently or within the past 6 weeks

          -  Use of zinc supplements or multivitamins containing zinc currently or within the past
             6 weeks

          -  Occupational exposure to dust or chemicals that may cause cough, as determined by
             study physician

          -  Diagnosis or evidence of chronic obstructive pulmonary disease (COPD) as defined by
             forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 0.70 and
             FEV1% predicted < 80%

          -  History of lung disease, such as:

               -  Bronchiectasis

               -  Interstitial lung disease

               -  Sarcoidosis

               -  Pneumoconiosis

               -  Asbestosis

               -  Chronic mycobacterial infection

               -  Lung cancer

          -  History of pancreatitis

          -  Congestive heart failure

          -  Chronic kidney disease (creatinine clearance < 30ml/min)

          -  Pregnant or breast-feeding

          -  Other medical conditions that would interfere with participation in study
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? 1