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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00534079
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena

Tracking Information
First Submitted Date  ICMJE September 21, 2007
First Posted Date  ICMJE September 24, 2007
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE September 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2007)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
  • 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 ]
  • Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients) [ Time Frame: day 1, 29, 57, 85 ]
  • Changes in the nasal lavage fluid and in the serological markers of inflammation [ Time Frame: day 1, 29, 57 and 85 ]
  • Changes in rhinoscopic findings [ Time Frame: day 1, 29, 57 and 85 ]
  • Changes in rhinomanometric findings [ Time Frame: day 1, 29, 27 and 85 ]
  • Incidence of rhinosinusitic and pulmonary exacerbations during therapy [ Time Frame: day 1 - 85 ]
  • Need for decongestants or nasal lavage during treatment [ Time Frame: day 1 - 85 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • Rhinosinusitis
Intervention  ICMJE
  • Drug: Dornase alfa (Pulmozyme)
    1 x 2,5 ml per day, inhalation use, for 28 days
  • Drug: isotonic saline
    1 x 2,5 ml per day, inhalation use, for 28 days
Study Arms  ICMJE
  • Experimental: Dornase alfa
    28 days of sinonasal inhalation (Pari Sinus)
    Interventions:
    • Drug: Dornase alfa (Pulmozyme)
    • Drug: isotonic saline
  • Placebo Comparator: isotonic saline
    28 days of sinonasal inhalation (Pari Sinus)
    Interventions:
    • Drug: Dornase alfa (Pulmozyme)
    • Drug: isotonic saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2014)
23
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00534079
Other Study ID Numbers  ICMJE pulmozyme-nasal-cf
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PD Dr. Jochen G. Mainz, University of Jena
Study Sponsor  ICMJE University of Jena
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jochen Mainz, M.D. University of Jena
PRS Account University of Jena
Verification Date December 2014

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