Pilot of Zinc Acetate to Improve Chronic Cough

Completed · Phase 2 · Has a placebo group

Conditions studied: Cough

In brief

The Pilot of Zinc Acetate to Improve Chronic Cough (ZICO) is a study of 36 patients with chronic refractory cough that will be used to (1) assess if zinc acetate (150 mg/day) will improve patient reported measures of cough, (2) to establish if treatment with zinc acetate is well tolerated, and (3) to determine if the trial logistics are feasible.

Key facts

Study ID

NCT03135522

Run by

Johns Hopkins University

People needed

34

Starts

2018-02-14

Expected to finish

2019-12-11

Last updated by the study team

2021-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• National Jewish Medical and Research Center — Denver, Colorado, United States
• St. Vincent Health — Indianapolis, Indiana, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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