Pulmozyme for Sjogren's Associated Cough

UConn Health

Overview

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.

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: 1. To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease. 2. To determine the effect of Pulmozyme use on pulmonary function in patients with chronic cough due to Sjogren's disease. 3. To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

Sjogren's Syndrome Cough

Interventions

Dornase alfaDRUG

Dose: 2.5 mg solution BID via nebuliser for 2 weeks

SalineDRUG

2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of CT Health Center

Farmington, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: After 2 weeks of therapy.

Secondary Outcomes

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%)

Time frame: After 2 weeeks of therapy

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.

Time frame: At start of 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.

Time frame: After 2 weeks of therapy.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.