Pulmozyme for Sjogren's Associated Cough
Information source: University of Connecticut Health Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sjogren's Syndrome; Cough
Intervention: Dornase alfa (Drug); Saline (Drug)
Phase: Phase 1
Status: Withdrawn
Sponsored by: University of Connecticut Health Center Official(s) and/or principal investigator(s): Metersky L Mark, MD, Principal Investigator, Affiliation: University of CT Health Center
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.
Clinical Details
Official title: A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale.
Secondary outcome: Change in spirometry, specifically 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. To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University of CT Health Center, Farmington, Connecticut 06030, United States
Additional Information
Starting date: May 2011
Last updated: March 29, 2012
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