Pulmozyme for Sjogren's Associated Cough

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01357447
• Other study ID #: 11-110-3
• Secondary ID: 002
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 2011
• Est. completion date: March 2012

Study information

• Verified date: January 2020
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cough
• Sjogren's Syndrome

Intervention

Drug:
• Dornase alfa
Dose: 2.5 mg solution BID via nebuliser for 2 weeks
• Saline
2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)

Locations

Country	Name	City	State
United States	University of CT Health Center	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
UConn Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.