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

September 21, 2007
November 25, 2009
September 2007
February 2009   (final data collection date for primary outcome measure)
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 ]
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)
Complete list of historical versions of study NCT00534079 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Rhinosinusitis
Drug: Dornase alfa (Pulmozyme)
1 x 2,5 mg per day, inhalation use, for 28 days
Not Provided
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-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00534079
pulmozyme-nasal-cf
Not Provided
Dr. Jochen Mainz, University of Jena, Children`s hospital
University of Jena
Not Provided
Study Chair: Jochen Mainz, M.D. University of Jena
University of Jena
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP