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Pulmozyme for Sjogren's Associated Cough

Primary Purpose

Sjogren's Syndrome, Cough

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dornase alfa
Saline
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sjogren's Syndrome focused on measuring Sjogren's syndrome, Cough

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or above with primary Sjogren's disease (as defined by the American European Consensus Group Criteria), and complaint of chronic cough.
  • Able to give consent and anticipated ability to adhere to the study procedures.

Exclusion Criteria:

  • Diagnosis of COPD, emphysema, asthma, chronic bronchitis, other clinically significant lung disease that is likely to cause cough. Interstitial lung disease associated with Sjogren's is not excluded.
  • Cigarette use of greater than 20 pack years or regular use within 6 months
  • Allergy or intolerance to Pulmozyme.
  • Acute respiratory infection or other acute respiratory illness during the prior month.
  • LCQ greater than 17 and VAS less than 3 cm at baseline (Visit 1).
  • Pregnancy or breast feeding.

Sites / Locations

  • University of CT Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dornase alfa (Pulmozyme)

Saline

Arm Description

Dornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA.

Normal saline 0.9% solution

Outcomes

Primary Outcome Measures

Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale.
To determine if the use of Pulmozyme, twice a day improves cough-related quality of life or cough severity in patients with chronic cough due to Sjogren's disease.

Secondary Outcome Measures

Change in spirometry, specifically FEV1, FVC, FEV1/FVC and FEF 25-75%
Changes in pulmonary function in study subjects with use of pulmozyme will be determined by measuring specific spirometric indices (FEV1, FVC, FEV1/FVC and FEF 25-75%)
To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.
Sputum from patients with chronic cough due to Sjogren's disease will be analyzed to determine the DNA content at the start of the study.
To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.
Adverse reactions, if any, due to use of Pulmozyme, taken twice a day in study patients, will be determined.

Full Information

First Posted
May 18, 2011
Last Updated
January 13, 2020
Sponsor
UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT01357447
Brief Title
Pulmozyme for Sjogren's Associated Cough
Official Title
A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled.
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with Sjogren's disease have destruction of the mucus secreting cells in the airway. This manifestation of the disease leads to the common complaint of persistent dry cough that is seen in many of these patients. This study is aimed at determining whether the regular use of Pulmozyme will result in decreased cough and improved quality of life.
Detailed Description
Patients with Sjogren's disease have destruction of the mucus secreting cells in the bronchi. This manifestation of the disease leads to the common complaint of persistent dry cough that is seen in many of these patients. The investigators theorize that regular use of Pulmozyme will result in decreased cough and improved quality of life, by improving mucus clearance. Primary Objective:To determine if the use of Pulmozyme, twice a day improves cough-related quality of life or cough severity in patients with chronic cough due to Sjogren's disease. Secondary Objectives: To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease. To determine the effect of Pulmozyme use on pulmonary function in patients with chronic cough due to Sjogren's disease. To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome, Cough
Keywords
Sjogren's syndrome, Cough

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dornase alfa (Pulmozyme)
Arm Type
Experimental
Arm Description
Dornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Normal saline 0.9% solution
Intervention Type
Drug
Intervention Name(s)
Dornase alfa
Other Intervention Name(s)
Pulmozyme
Intervention Description
Dose: 2.5 mg solution BID via nebuliser for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)
Primary Outcome Measure Information:
Title
Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale.
Description
To determine if the use of Pulmozyme, twice a day improves cough-related quality of life or cough severity in patients with chronic cough due to Sjogren's disease.
Time Frame
After 2 weeks of therapy.
Secondary Outcome Measure Information:
Title
Change in spirometry, specifically FEV1, FVC, FEV1/FVC and FEF 25-75%
Description
Changes in pulmonary function in study subjects with use of pulmozyme will be determined by measuring specific spirometric indices (FEV1, FVC, FEV1/FVC and FEF 25-75%)
Time Frame
After 2 weeeks of therapy
Title
To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.
Description
Sputum from patients with chronic cough due to Sjogren's disease will be analyzed to determine the DNA content at the start of the study.
Time Frame
At start of study
Title
To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.
Description
Adverse reactions, if any, due to use of Pulmozyme, taken twice a day in study patients, will be determined.
Time Frame
After 2 weeks of therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or above with primary Sjogren's disease (as defined by the American European Consensus Group Criteria), and complaint of chronic cough. Able to give consent and anticipated ability to adhere to the study procedures. Exclusion Criteria: Diagnosis of COPD, emphysema, asthma, chronic bronchitis, other clinically significant lung disease that is likely to cause cough. Interstitial lung disease associated with Sjogren's is not excluded. Cigarette use of greater than 20 pack years or regular use within 6 months Allergy or intolerance to Pulmozyme. Acute respiratory infection or other acute respiratory illness during the prior month. LCQ greater than 17 and VAS less than 3 cm at baseline (Visit 1). Pregnancy or breast feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Metersky L Mark, MD
Organizational Affiliation
University of CT Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of CT Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

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Pulmozyme for Sjogren's Associated Cough

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