CompletedNCT00534079Updated Dec 4, 2014

Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

A Phase 3 interventional study of Dornase alfa (Pulmozyme) and isotonic saline in Cystic Fibrosis and Rhinosinusitis, sponsored by University of Jena. Completed at 2 sites in Germany. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2014-12-04.

Sponsored by University of Jena · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 23
Allocation: Randomized
Ages: 5 Years and older
Sex: All

Study summary

Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a dysfunction of chloride channels in exocrine glands, leading to retention of secretions and consecutive chronic inflammation with bacterial superinfections.

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.

Conditions studied

Cystic Fibrosis
Rhinosinusitis

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Keywords

Cystic Fibrosis and chronic rhinosinusitis

In context

Rhinosinusitis

330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.

This study's enrollment of 23 is below the median of 60 across 227 interventional studies indexed under Rhinosinusitis.

Browse Rhinosinusitis studies →

Lead sponsor

University of Jena is the lead sponsor of 89 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 5 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subject has a confirmed diagnosis of cystic fibrosis based on: 3 positive sweat chloride tests and/or genetic characterisation
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

Exclusion Criteria:

Subject has a critical condition defined as: FEV1 \< 30% and / or SaO2 \< 93% without O2-substitution; need of O2-substitution
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 23 participants (actual)

Study arms

Experimental
Dornase alfa
28 days of sinonasal inhalation (Pari Sinus)
Drug: Dornase alfa (Pulmozyme) · Drug: isotonic saline
Placebo comparator
isotonic saline
28 days of sinonasal inhalation (Pari Sinus)
Drug: Dornase alfa (Pulmozyme) · Drug: isotonic saline

Interventions

DrugDornase alfa (Pulmozyme)
1 x 2,5 ml per day, inhalation use, for 28 days
Drugisotonic saline
1 x 2,5 ml per day, inhalation use, for 28 days

What researchers measure

Primary outcomes

Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches)
Time frame: day 1, 29, 57 and 85

Secondary outcomes

Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (secondary nasal parameters, general quality of live parameters and total SNOT 20 adapt. CF score)
Time frame: day 1, 29, 57 and 85
Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients)
Time frame: day 1, 29, 57, 85
Changes in the nasal lavage fluid and in the serological markers of inflammation
Time frame: day 1, 29, 57 and 85
Changes in rhinoscopic findings
Time frame: day 1, 29, 57 and 85
Changes in rhinomanometric findings
Time frame: day 1, 29, 27 and 85
Incidence of rhinosinusitic and pulmonary exacerbations during therapy
Time frame: day 1 - 85
Need for decongestants or nasal lavage during treatment
Time frame: day 1 - 85

Study locations

2 sites

Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg 72076, Germany
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thüringen 07740, Germany

References and documents

Publications

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. PubMed 25081561 ↗
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. PubMed 24594542 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00534079
Lead sponsor: University of Jena
Responsible party: PD Dr. Jochen G. Mainz (Head of CF Center, University of Jena) — Principal investigator
First posted: Sep 24, 2007
Start date: Sep 2007
Primary completion: Feb 2009
Completion: Feb 2009
Last update: Dec 4, 2014

Study contacts

Jochen Mainz, M.D.

study chair · University of Jena

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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