Clinical trial NCT01357447: Pulmozyme for Sjogren's Associated Cough
Official title: A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Sjogren's Syndrome
Cough
Keywords: Sjogren's syndrome
Cough
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale.
timeFrame: After 2 weeks of therapy.
Secondary outcomes:
measure: Change in spirometry, specifically FEV1, FVC, FEV1/FVC and FEF 25-75%
timeFrame: After 2 weeeks of therapy
measure: To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.
timeFrame: At start of study
measure: To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.
timeFrame: After 2 weeks of therapy.
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of CT Health Center
state: Connecticut
Study officials:
affiliation: University of CT Health Center
name: Metersky L Mark, MD
role: PRINCIPAL_INVESTIGATOR
References: