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primary studies published RCT

Recombinant DNase in cystic fibrosis: a protocol for targeted introduction through n-of-1 trials. Scottish Cystic Fibrosis Group.

  • Year: 1999
  • Date: 1999
  • Author: Bollert FG
Source

Eur Respir J. 1999 Jan;13(1):107-13.

Study design (if review, criteria of inclusion for studies)

randomized, double-blind, placebo-controlled n-of-1 assessment protocol

Participants

89 4-week assessments in 52 patients were reported. Twenty-four patients have completed the assessment process (12 responders and 12 nonresponders) to date.

Interventions

Nebulized recombinant human deoxyribonuclease (DNase). Patients underwent a maximum of three 4-week assessment periods (2 weeks saline, 2 weeks DNase each).

Outcome measures

Measurements performed at hospital (exercise, oximetry and spirometry) and home (symptom scores) were used to derive a scoring syste

Main results

Forced expiratory volume in one second (FEVI) was the best discriminator of response, rising by >200 mL after DNase in 33 of 89 (37%) assessments compared with 3 of 89 (3%) after saline

Related topics

Inhaled antibiotics in cystic fibrosis

Keywords: Adolescent; Adult; Deoxyribonuclease; Airway clearance drugs -expectorants- mucolytic- mucociliary-; pharmacological_intervention; Recombinant Proteins; Respiratory System Agents; Dornase alpha; Pulmozyme; Inhalation OR nebulised; nebuliser;