NCT01357447

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

May 18, 2011

Last Update Submit

January 13, 2020

Conditions

Sjogren's SyndromeCough

Keywords

Sjogren's syndromeCough

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in spirometry, specifically FEV1, FVC, FEV1/FVC and FEF 25-75%

    After 2 weeeks of therapy

  • To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.

    At start of study

  • To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.

    After 2 weeks of therapy.

Study Arms (2)

Dornase alfa (Pulmozyme)

EXPERIMENTAL

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

Drug: Saline

Saline

PLACEBO COMPARATOR

Normal saline 0.9% solution

Drug: Dornase alfaDrug: Saline

Interventions

Dornase alfaDRUG

Dose: 2.5 mg solution BID via nebuliser for 2 weeks

Also known as: Pulmozyme
Saline
SalineDRUG

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

Dornase alfa (Pulmozyme)Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of CT Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Sjogren's SyndromeCough

Interventions

dornase alfaSodium Chloride

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Metersky L Mark, MD

    University of CT Health Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 20, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(1)