Pilot of Zinc Acetate to Improve Chronic Cough

NCT03135522 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB001325341R34HL132369-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

Cough

Keywords

Chronic cough; Refractory cough; Chronic refractory cough; Zinc; Zinc acetate

Outcome Measures

Primary Outcomes (1)

• Change in Cough Quality of Life Questionnaire (CQLQ) Score by Treatment Group

  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.

  Baseline and 6 weeks

Secondary Outcomes (3)

• Change in Leicester Cough Questionnaire (LCQ) Score by Treatment Group

  Baseline and 6 weeks

• Change in Cough Visual Assessment Scale (C-VAS) Scores by Treatment Group

  Baseline and 6 weeks

• Change in Global Assessment of Change in Cough (GACC) Score by Treatment Group

  Baseline and 6 weeks

Study Arms (2)

Zinc Acetate 50 mg oral capsule

ACTIVE COMPARATOR

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

Placebo oral capsule

PLACEBO COMPARATOR

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

Interventions

Zinc Acetate 50 Mg Oral Capsule DRUG

* 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)

Also known as: Galzin

Zinc Acetate 50 mg oral capsule

Placebo oral capsule DRUG

* 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)

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Lung Association: collaborator

Study Sites (5)

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

St. Vincent Health

Indianapolis, Indiana, 46260, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cough; Chronic Cough

Interventions

Zinc Acetate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Robert A. Wise, M.D.
• Organization: The Johns Hopkins University School of Medicine

rwise@jhmi.edu

410-905-5688

Study Officials

• Robert Wise, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Janet Holbrook, PhD

  Johns Hopkins University Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: February 14, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: January 20, 2021
• Results First Posted: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)