Pulmozyme for Sjogren's Associated Cough

UConn Health

Status and phase: Withdrawn; Phase 1

Conditions: Sjogren's Syndrome; Cough

Treatments: Drug: Saline; Drug: Dornase alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT01357447

11-110-3

002

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Dornase alfa (Pulmozyme)

Experimental group

Description:

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

Treatment:

Drug: Saline

Saline

Placebo Comparator group

Description:

Normal saline 0.9% solution

Treatment:

Drug: Saline

Drug: Dornase alfa