Sjogren's Syndrome, Cough
Conditions
Keywords
Sjogren's syndrome, Cough
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.
Interventions
DRUGDornase alfa
Dose: 2.5 mg solution BID via nebuliser for 2 weeks
DRUGSaline
2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)
Sponsors
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed