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| ID | Type | Description | Link |
|---|---|---|---|
| 002 | Other Identifier | University of CT Health Center |
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No patients enrolled.
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dornase alfa (Pulmozyme) | Experimental | Dornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. |
|
| Saline | Placebo Comparator | Normal saline 0.9% solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dornase alfa | Drug | Dose: 2.5 mg solution BID via nebuliser for 2 weeks |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Metersky L Mark, MD | University of CT Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of CT Health Center | Farmington | Connecticut | 06030 | United States |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D003371 | Cough |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C568813 | dornase alfa |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | 2.5 ml via nebuliser BID for 2 weeks (alternating with study drug) |
|
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. |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |