Pulmozyme for Sjogren's Associated Cough

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cough; Sjogren's Syndrome
• Intervention / Treatment: Drug: Saline; Drug: Dornase alfa

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.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of CT Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: UConn Health
• Investigators: Principal Investigator: Metersky L Mark, MD, University of CT Health Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: May 19, 2011
• First Posted (ESTIMATE): May 20, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Cough; Sjogren's syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Respiration Disorders; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Signs and Symptoms, Respiratory; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Cough; Sjogren's Syndrome
• Other Study ID Numbers: 11-110-3; 002 (University of CT Health Center)