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Pulmozyme for Sjogren's Associated Cough

This study has been withdrawn prior to enrollment.
(No patients enrolled.)
Sponsor:
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01357447
First received: May 18, 2011
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sjogren's Syndrome
Cough
 Drug: Dornase alfa
Drug: Saline
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale. [ Time Frame: After 2 weeks of therapy. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in spirometry, specifically FEV1, FVC, FEV1/FVC and FEF 25-75% [ Time Frame: After 2 weeeks of therapy ] [ Designated as safety issue: No ]
    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. [ Time Frame: At start of study ] [ Designated as safety issue: No ]
    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. [ Time Frame: After 2 weeks of therapy. ] [ Designated as safety issue: No ]
    Adverse reactions, if any, due to use of Pulmozyme, taken twice a day in study patients, will be determined.


Enrollment: 0
Study Start Date: May 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Dornase alfa
Dose: 2.5 mg solution BID via nebuliser for 2 weeks
Other Name: Pulmozyme
Drug: Saline
2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357447

Locations
United States, Connecticut
University of CT Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Metersky L Mark, MD University of CT Health Center
  More Information

No publications provided

Responsible Party: Mark Metersky, MD, University of CT Health Center
ClinicalTrials.gov Identifier: NCT01357447     History of Changes
Other Study ID Numbers: 11-110-3, 002
Study First Received: May 18, 2011
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Sjogren's syndrome
Cough

Additional relevant MeSH terms:
Cough
Sjogren's Syndrome
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013