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

This study has been completed.
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00534079
First received: September 21, 2007
Last updated: November 25, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Rhinosinusitis
Drug: Dornase alfa (Pulmozyme)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Jena:

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) [ Time Frame: day 1, 29, 57 and 85 ] [ Designated as safety issue: No ]

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) [ Time Frame: day 1, 29, 57 and 85 ] [ Designated as safety issue: No ]
  • Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients) [ Time Frame: day 1, 29, 57, 85 ] [ Designated as safety issue: No ]
  • Changes in the nasal lavage fluid and in the serological markers of inflammation [ Time Frame: day 1, 29, 57 and 85 ] [ Designated as safety issue: No ]
  • Changes in rhinoscopic findings [ Time Frame: day 1, 29, 57 and 85 ] [ Designated as safety issue: No ]
  • Changes in rhinomanometric findings [ Time Frame: day 1, 29, 27 and 85 ] [ Designated as safety issue: No ]
  • Incidence of rhinosinusitic and pulmonary exacerbations during therapy [ Time Frame: day 1 - 85 ] [ Designated as safety issue: No ]
  • Need for decongestants or nasal lavage during treatment [ Time Frame: day 1 - 85 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: September 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dornase alfa (Pulmozyme)
    1 x 2,5 mg per day, inhalation use, for 28 days
  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534079

Locations
Germany
Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg, Germany, 72076
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thüringen, Germany, 07740
Sponsors and Collaborators
University of Jena
Investigators
Study Chair: Jochen Mainz, M.D. University of Jena
  More Information

No publications provided by University of Jena

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Jochen Mainz, University of Jena, Children`s hospital
ClinicalTrials.gov Identifier: NCT00534079     History of Changes
Other Study ID Numbers: pulmozyme-nasal-cf
Study First Received: September 21, 2007
Last Updated: November 25, 2009
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by University of Jena:
Cystic Fibrosis and chronic rhinosinusitis

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Sinusitis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 01, 2014