Pulmozyme for Sjogren's Associated Cough
- Registration Number
- NCT01357447
- Lead Sponsor
- UConn Health
- 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:
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Saline Saline Normal saline 0.9% solution Dornase alfa (Pulmozyme) Saline Dornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. Saline Dornase alfa Normal saline 0.9% solution
- Primary Outcome Measures
Name Time Method Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale. After 2 weeks of therapy. 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
Name Time Method Change in spirometry, specifically FEV1, FVC, FEV1/FVC and FEF 25-75% After 2 weeeks of therapy 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. At start of study 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. After 2 weeks of therapy. Adverse reactions, if any, due to use of Pulmozyme, taken twice a day in study patients, will be determined.
Trial Locations
- Locations (1)
University of CT Health Center
🇺🇸Farmington, Connecticut, United States