Sjogren's SyndromePhase 1NCT01357447
Pulmozyme for Sjogren's Associated Cough
A Phase 1 study testing Dornase alfa and Saline in people with Sjogren's Syndrome and Cough, run by UConn Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome, Cough
- What is being tested?
- Dornase alfa and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of CT Health Center
Farmington, Connecticut, 06030
About this study
Official title: A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough
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.
Read the detailed 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:
- To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.
- To determine the effect of Pulmozyme use on pulmonary function in patients with chronic cough due to Sjogren's disease.
- To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.
- Conditions
- Sjogren's Syndrome, Cough
- Being tested
- Dornase alfa, Saline
- Keywords
- Sjogren's syndrome, Cough
- Medical subject headings
- Sjogren's Syndrome, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dornase alfaDrug
Also called Pulmozyme
Dose: 2.5 mg solution BID via nebuliser for 2 weeks
SalineDrug
2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)
| Study group | Role | What they receive |
|---|---|---|
| Dornase alfa (Pulmozyme) | Experimental | Dornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. Receives: Drug: Saline |
| Saline | Placebo comparator | Normal saline 0.9% solution Receives: Drug: Dornase alfa; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 2 weeks of therapy.
Secondary outcomes (3)
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%)
Measured: After 2 weeeks of therapy
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.
Measured: At start of study
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.
Measured: After 2 weeks of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: No patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Metersky L Mark, MD, Principal investigator, University of CT Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357447
- Sponsor's protocol ID
- 11-110-3
- Other IDs
- 002
- Status last verified
- Jan 2020
- First submitted
- 18 May 2011
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough
- ClinicalTrials.gov ID
- NCT01357447
- Acronym / sponsor ID
- 11-110-3
- Conditions
- Sjogren's Syndrome, Cough
- Keywords
- Sjogren's syndrome, Cough
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.
- To determine the effect of Pulmozyme use on pulmonary function in patients with chronic cough due to Sjogren's disease.
- To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dornase alfa (Pulmozyme) | Experimental | Drug: SalineDornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. |
| Saline | Placebo comparator | Drug: Dornase alfa, Drug: SalineNormal saline 0.9% solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dornase alfaAlso: PulmozymeDose: 2.5 mg solution BID via nebuliser for 2 weeks | Drug | Saline |
| Saline2.5 ml via nebuliser BID for 2 weeks (alternating with study drug) | Drug | Dornase alfa (Pulmozyme), Saline |
Primary outcome
Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale.
Time frame: After 2 weeks of therapy.
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.
3 secondary outcomes
Change in spirometry, specifically FEV1, FVC, FEV1/FVC and FEF 25-75%
Time frame: After 2 weeeks of therapy
To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.
Time frame: At start of study
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Related trials for Sjogren's Syndrome
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
RecruitingPhase 2
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Sjögren's Disease
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Metersky L Mark, MD principal investigator
University of CT Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dornase alfa and Saline in people with Sjogren's Syndrome and Cough, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale. (time frame: After 2 weeks of therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.