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NCT Number: NCT00534079

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Infections Lung Diseases Nose Diseases Otorhinolaryngologic Diseases Pancreatic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinosinusitis Sinusitis

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitäts-Kinderklinik, Tübingen, Baden-Würtemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dornase alfa (Pulmozyme)

Drug

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

Isotonic saline

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

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

    Time frame: day 1, 29, 57, 85

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

    Time frame: day 1, 29, 57 and 85

  4. Changes in rhinoscopic findings

    Time frame: day 1, 29, 57 and 85

  5. Changes in rhinomanometric findings

    Time frame: day 1, 29, 27 and 85

  6. Incidence of rhinosinusitic and pulmonary exacerbations during therapy

    Time frame: day 1 - 85

  7. Need for decongestants or nasal lavage during treatment

    Time frame: day 1 - 85

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 24, 2007
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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