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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01357447 |
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Date of registration:
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18/05/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pulmozyme for Sjogren's Associated Cough
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Scientific title:
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A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT01357447 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Metersky L Mark, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of CT Health Center |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sjogren's Syndrome
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Cough
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Intervention(s)
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Drug: Saline
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Drug: Dornase alfa
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Primary Outcome(s)
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Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale.
[Time Frame: After 2 weeks of therapy.]
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Secondary Outcome(s)
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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.]
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To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.
[Time Frame: At start of study]
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Change in spirometry, specifically FEV1, FVC, FEV1/FVC and FEF 25-75%
[Time Frame: After 2 weeeks of therapy]
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Secondary ID(s)
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11-110-3
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002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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