Pulmozyme for Sjogren's Associated Cough

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sjogren's Syndrome, Cough

Intervention / Treatment
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* Drug: Dornase alfa
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dornase alfa (Pulmozyme)<br>Dornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. | Drug: Saline<br>* 2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)<br>|
| Placebo Comparator: Saline<br>Normal saline 0.9% solution | Drug: Dornase alfa<br>* Dose: 2.5 mg solution BID via nebuliser for 2 weeks<br>* Other names: Pulmozyme;Drug: Saline<br>* 2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After 2 weeks of therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%) | 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. | 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. | After 2 weeks of therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjogren's syndrome, Cough