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

Cystic Fibrosis Clinical Trial

Official title:

Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-controlled Cross-over, Bicenter, Prospective Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534079
• Other study ID #: pulmozyme-nasal-cf
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2007
• Last updated: December 3, 2014
• Start date: September 2007
• Est. completion date: February 2009

Study information

• Verified date: December 2014
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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:

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Rhinosinusitis
• Sinusitis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	Mukoviszidosezentrum der Friedrich-Schiller-Universität	Jena	Thüringen
Germany	Universitäts-Kinderklinik	Tübingen	Baden-Würtemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

Mainz JG, Schien C, Schiller I, Schädlich K, Koitschev A, Koitschev C, Riethmüller 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-contr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		day 1, 29, 57 and 85	No
Secondary	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)		day 1, 29, 57 and 85	No
Secondary	Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients)		day 1, 29, 57, 85	No
Secondary	Changes in the nasal lavage fluid and in the serological markers of inflammation		day 1, 29, 57 and 85	No
Secondary	Changes in rhinoscopic findings		day 1, 29, 57 and 85	No
Secondary	Changes in rhinomanometric findings		day 1, 29, 27 and 85	No
Secondary	Incidence of rhinosinusitic and pulmonary exacerbations during therapy		day 1 - 85	No
Secondary	Need for decongestants or nasal lavage during treatment		day 1 - 85	No