Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
NCT ID: NCT00534079
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
23 participants
INTERVENTIONAL
2007-09-30
2009-02-28
Brief Summary
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The prospective placebo controlled cross-over study aims at the evaluation of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Dornase alfa
28 days of sinonasal inhalation (Pari Sinus)
Dornase alfa (Pulmozyme)
1 x 2,5 ml per day, inhalation use, for 28 days
isotonic saline
1 x 2,5 ml per day, inhalation use, for 28 days
isotonic saline
28 days of sinonasal inhalation (Pari Sinus)
Dornase alfa (Pulmozyme)
1 x 2,5 ml per day, inhalation use, for 28 days
isotonic saline
1 x 2,5 ml per day, inhalation use, for 28 days
Interventions
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Dornase alfa (Pulmozyme)
1 x 2,5 ml per day, inhalation use, for 28 days
isotonic saline
1 x 2,5 ml per day, inhalation use, for 28 days
Eligibility Criteria
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Inclusion Criteria
* Subject is 5 years of age or older
* Subject has chronic or recurrent rhinosinusitic disorders
* Subject is able to comply with the procedures scheduled in the protocol
* Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (e.g. implants, combined oral contraceptives, injectables, some IUDs, sexual abstinence or vasectomised partner)
Exclusion Criteria
* Subject had an ENT surgery within 6 months prior to study
* Subject shows signs of nasal bleeding
* Subject has an ear drum perforation
* Subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy
* Subject has a new therapy with nasal topic steroids during treatment interval
* Subject has a new systemic steroid therapy
* Subject is unlikely to comply with the procedures scheduled in the protocol
* Subject has a known allergic reaction to the medication
* Subject is pregnant or breastfeeding
* Patient participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.
5 Years
ALL
No
Sponsors
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University of Jena
OTHER
Responsible Party
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PD Dr. Jochen G. Mainz
Head of CF Center
Principal Investigators
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Jochen Mainz, M.D.
Role: STUDY_CHAIR
University of Jena
Locations
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Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg, Germany
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thuringia, Germany
Countries
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References
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Mainz JG, Michl R, Arnold C. Response to Karadag. J Cyst Fibros. 2014 Sep;13(5):602-3. doi: 10.1016/j.jcf.2014.07.005. Epub 2014 Jul 28. No abstract available.
Mainz JG, Schien C, Schiller I, Schadlich K, Koitschev A, Koitschev C, Riethmuller J, Graepler-Mainka U, Wiedemann B, Beck JF. Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial. J Cyst Fibros. 2014 Jul;13(4):461-70. doi: 10.1016/j.jcf.2014.02.005. Epub 2014 Mar 1.
Other Identifiers
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pulmozyme-nasal-cf
Identifier Type: -
Identifier Source: org_study_id