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Pilot of Zinc Acetate to Improve Chronic Cough (ZICO)

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ClinicalTrials.gov Identifier: NCT03135522
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Lung Association
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Cough Drug: Zinc Acetate 50 Mg Oral Capsule Drug: Placebo oral capsule Phase 2

Detailed Description:
Chronic refractory cough in adults is defined as a cough lasting more than 8 weeks that does not resolve with treatment for asthma/eosinophilic airway disease, gastroesophageal reflux disease (GERD), or rhinosinusitis/post-nasal drip; and is not caused by smoking, angiotensin-converting-enzyme (ACE) inhibitors, or parenchymal lung disease. This is one of the most common conditions leading to specialty referral accounting for about 20% of new pulmonary consultations. Chronic refractory cough leads to severe impairment of quality of life and social isolation as well as sleep deprivation and chronic fatigue. The few available treatments have limited benefit and substantial side effects or abuse potential. While there are validated tools to measure the health-impact of chronic cough which can provide feasible clinical trial outcome measures, there have been no academic multi-center trials of chronic cough, and guidelines for treatment continue to rely largely on opinion rather than evidence. ZICO is a small scale randomized proof-of-concept clinical trial to establish the safety and tolerability of zinc in this population. The primary outcome measure will be the Cough Specific Quality of Life Questionnaire (CQLQ). Participants will be 18 years or older, with chronic cough lasting at least 3 months, which has been unresponsive to treatments for asthma, GERD or other upper airway disease. Individuals that are current smokers, use an ACE inhibitor, currently take zinc supplements (or multivitamins with zinc), or whose medical history includes primary parenchymal lung disease, congestive heart failure, chronic kidney disease, or another medical condition that could interfere with the study or are pregnant or breast-feeding will be excluded. Participants will be randomized to receive 6 weeks of treatment with either zinc acetate or placebo. Follow-up assessments will occur at 1, 3, 6 and 8 weeks after randomization; the final assessment is after a two week washout to establish the duration of treatment effect. In addition to completing a daily cough diary, participants will complete cough specific and general quality of life measures, complete spirometry testing and have serum zinc and copper levels measured.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot of Zinc Acetate to Improve Chronic Cough
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Active Comparator: Zinc Acetate 50 mg oral capsule
50 mg zinc acetate oral capsules, over-encapsulated, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)
Drug: Zinc Acetate 50 Mg Oral Capsule
  • Day 0 (randomization) to day 3 Zinc acetate 50 mg per day (one capsule)
  • Day 4 to day 7 If well tolerated: Zinc acetate 100 mg per day (two capsules)
  • Day 8 to V5 (6 weeks) If well tolerated: Zinc acetate 150 mg per day (three capsules)
Other Name: Galzin

Placebo Comparator: Placebo oral capsule
Placebo matched to zinc acetate 50 mg oral capsule active arm, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)
Drug: Placebo oral capsule
  • Day 0 (randomization) to day 3 Placebo (one capsule per day)
  • Day 4 to day 7 If well tolerated: placebo (two capsules per day)
  • Day 8 to V5 (6 weeks) If well tolerated: placebo (three capsules per day)




Primary Outcome Measures :
  1. Change in Cough Quality of Life Questionnaire (CQLQ) Score by Treatment Group [ Time Frame: 6 weeks ]
    Unadjusted comparison of change in CQLQ score between zinc acetate and placebo treatment groups. CQLQ scores range from 28 to 112, with lower scores indicating fewer adverse events. A minimum clinically importance difference of 5 has been proposed for this questionnaire.


Secondary Outcome Measures :
  1. Change in Leicester Cough Questionnaire (LCQ) Score by Treatment Group [ Time Frame: 6 weeks ]
    Unadjusted comparison of change in LCQ scores between zinc acetate and placebo treatment groups. LCQ scores range from 3 to 21, with lower scores indicating a greater impact of cough upon one's life. The minimum clinically importance difference for the LCQ for people with chronic cough is 1.3.

  2. Change in Cough Visual Assessment Scale (C-VAS) Scores by Treatment Group [ Time Frame: 6 weeks ]
    Unadjusted comparison of change in C-VAS between zinc acetate and placebo treatment groups. C-VAS scores cover four domains - severity of cough in daytime, nighttime, and overall, and severity of urge to cough. Scores range from 0 to 100 for each domain with lower scores indicating less severity.

  3. Change in Global Assessment of Change in Cough (GACC) Score by Treatment Group [ Time Frame: 6 weeks ]
    Unadjusted comparison of change in GACC scores between zinc acetate and placebo treatment groups. GACC scores measure change in quality of life related to cough in four domains - activity limitation, symptoms, emotions, and overall quality of life. GACC scores range from -3 (very much worse) to 3 (very much better).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Congestive heart failure
  • Chronic kidney disease (creatinine clearance < 30ml/min)
  • Pregnant or breast-feeding
  • Other medical conditions that would interfere with participation in study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135522


Contacts
Contact: Alexis Rea (443) 287-8496 area5@jhu.edu
Contact: Heather Hazucha, MPH hhazuch1@jhu.edu

Locations
United States, Colorado
National Jewish Medical and Research Center Recruiting
Denver, Colorado, United States, 80206
Contact: Juno Pak    303-398-1233    pakj@njhealth.org   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jaime Tarsi    314-747-3074    jtarsi@dom.wustl.edu   
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Karol Perez    212-241-9538    karol.perez@mssm.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Catherine Foss    919-668-6530    catherine.foss@duke.edu   
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
American Lung Association
Investigators
Principal Investigator: Robert Wise, MD Johns Hopkins University
Principal Investigator: Janet Holbrook, PhD Johns Hopkins University Bloomberg School of Public Health

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03135522     History of Changes
Other Study ID Numbers: IRB00132534
1R34HL132369-01 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Johns Hopkins University:
Chronic cough
Refractory cough
Chronic refractory cough
Zinc
Zinc acetate

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs