Pulmozyme for Sjogren's Associated Cough

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sjogren's Syndrome Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dornase alfa (Pulmozyme)

Dornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA.

Group Type EXPERIMENTAL

Saline

Intervention Type DRUG

2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)

Saline

Normal saline 0.9% solution

Group Type PLACEBO_COMPARATOR

Dornase alfa

Intervention Type DRUG

Dose: 2.5 mg solution BID via nebuliser for 2 weeks

Saline

Intervention Type DRUG

2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)

Interventions

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Dornase alfa

Dose: 2.5 mg solution BID via nebuliser for 2 weeks

Intervention Type DRUG

Saline

2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)

Intervention Type DRUG

Other Intervention Names

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Pulmozyme

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No