Pilot of Zinc Acetate to Improve Chronic Cough

• Status: Completed
• Trial end date: 2019-12-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: American Lung Association; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Zinc

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