Phase 2
N=34
Pilot of Zinc Acetate to Improve Chronic Cough
Cough
Bottom Line
View on ClinicalTrials.gov: NCT03135522 ↗Enrolled (actual)
34
Serious AEs
8.8%
Results posted
Dec 2020
Primary outcome: Primary: Change in Cough Quality of Life Questionnaire (CQLQ) Score by Treatment Group — -5.00; -6.00 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zinc Acetate 50 Mg Oral Capsule (Drug); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cough Quality of Life Questionnaire (CQLQ) Score by Treatment Group |
-5.00; -6.00 | — |
| SECONDARY Change in Leicester Cough Questionnaire (LCQ) Score by Treatment Group |
2.55; 2.59 | — |
| SECONDARY Change in Cough Visual Assessment Scale (C-VAS) Scores by Treatment Group |
-15.24; -17.82 | — |
| SECONDARY Change in Global Assessment of Change in Cough (GACC) Score by Treatment Group |
0.50; 0.25 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03135522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.