MedDataX Logo

Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

NCT ID: NCT00265434

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 the efficacy of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis Chronic Rhinosinusitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dornase alfa

DBPC-cross over trial

Group Type ACTIVE_COMPARATOR

Pulmozyme

Intervention Type DRUG

isotonic saline

Group Type PLACEBO_COMPARATOR

Pulmozyme

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulmozyme

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject has a confirmed diagnosis of cystic fibrosis.
* Subject has chronic or recurrent rhinosinusitic disorders.
* Subject is 5 years or older.

Exclusion Criteria

* Subject has a critical condition (FEV1\<30% and SaO2\<93%).
* Subject had an ENT surgery within 6 months prior to study.
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PD Dr. Joachim Riethmöller, Tübingen

UNKNOWN

Sponsor Role collaborator

PD Dr. Assen Koitschev, Tübingen

UNKNOWN

Sponsor Role collaborator

Dr. Gerlind Schneider

UNKNOWN

Sponsor Role collaborator

University of Jena

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

PD Dr. Jochen G. Mainz

Head of CF Center, Pediatric Pulmonology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jochen G. Mainz, M.D.

Role: STUDY_CHAIR

University of Jena

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Friedrich-Schiller-Universität

Jena, Thuringia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Mainz JG, Schiller I, Ritschel C, Mentzel HJ, Riethmuller J, Koitschev A, Schneider G, Beck JF, Wiedemann B. Sinonasal inhalation of dornase alfa in CF: A double-blind placebo-controlled cross-over pilot trial. Auris Nasus Larynx. 2011 Apr;38(2):220-7. doi: 10.1016/j.anl.2010.09.001. Epub 2010 Oct 27.

Reference Type BACKGROUND
PMID: 21030168 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

pilot-pulmozyme-nasal-cf

Identifier Type: -

Identifier Source: org_study_id