Phase 2
Completed N=34
Pilot of Zinc Acetate to Improve Chronic Cough
Cough
Source: ClinicalTrials.gov NCT03135522 ↗
Enrolled (actual)
34
Serious AEs
8.8%
Results posted
Dec 2020
Primary outcomePrimary: Change in Cough Quality of Life Questionnaire (CQLQ) Score by Treatment Group — -5.00; -6.00 score on a scale
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.
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 | — |
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. Informational only — not medical advice.