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

Primary Purpose

Cystic Fibrosis, Rhinosinusitis

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Dornase alfa (Pulmozyme)

isotonic saline

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis and chronic rhinosinusitis

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Universitäts-Kinderklinik
Mukoviszidosezentrum der Friedrich-Schiller-Universität

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dornase alfa

isotonic saline

Arm Description

28 days of sinonasal inhalation (Pari Sinus)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients)

Changes in the nasal lavage fluid and in the serological markers of inflammation

Changes in rhinoscopic findings

Changes in rhinomanometric findings

Incidence of rhinosinusitic and pulmonary exacerbations during therapy

Need for decongestants or nasal lavage during treatment

Full Information

NCT ID

NCT00534079

First Posted

September 21, 2007

Last Updated

December 3, 2014

Sponsor

University of Jena

1. Study Identification

Unique Protocol Identification Number

NCT00534079

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Jena

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Rhinosinusitis

Keywords

Cystic Fibrosis and chronic rhinosinusitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dornase alfa

Arm Type

Experimental

Arm Description

28 days of sinonasal inhalation (Pari Sinus)

Arm Title

isotonic saline

Arm Type

Placebo Comparator

Arm Description

28 days of sinonasal inhalation (Pari Sinus)

Intervention Type

Drug

Intervention Name(s)

Dornase alfa (Pulmozyme)

Intervention Description

1 x 2,5 ml per day, inhalation use, for 28 days

Intervention Type

Drug

Intervention Name(s)

isotonic saline

Intervention Description

1 x 2,5 ml per day, inhalation use, for 28 days

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients)

Time Frame

day 1, 29, 57, 85

Title

Changes in the nasal lavage fluid and in the serological markers of inflammation

Time Frame

day 1, 29, 57 and 85

Title

Changes in rhinoscopic findings

Time Frame

day 1, 29, 57 and 85

Title

Changes in rhinomanometric findings

Time Frame

day 1, 29, 27 and 85

Title

Incidence of rhinosinusitic and pulmonary exacerbations during therapy

Time Frame

day 1 - 85

Title

Need for decongestants or nasal lavage during treatment

Time Frame

day 1 - 85

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jochen Mainz, M.D.

Organizational Affiliation

University of Jena

Official's Role

Study Chair

Facility Information:

Facility Name

Universitäts-Kinderklinik

City

Tübingen

State/Province

Baden-Würtemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Mukoviszidosezentrum der Friedrich-Schiller-Universität

City

Jena

State/Province

Thüringen

ZIP/Postal Code

07740

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25081561

Citation

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.

Results Reference

background

PubMed Identifier

24594542

Citation

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.

Results Reference

result

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

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