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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01357447
Other study ID # 11-110-3
Secondary ID 002
Status Withdrawn
Phase Phase 1
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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.
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