NCT01357447

Pulmozyme for Sjogren's Associated Cough

A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

• Sjogren's Syndrome
• Cough

Interventions

Type	Name	Description
DRUG	Dornase alfa	Dose: 2.5 mg solution BID via nebuliser for 2 weeks
DRUG	Saline	2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-05-20
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States