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Clinical Trials/ISRCTN65617839
ISRCTN65617839
Completed
Not Applicable

A pilot randomised controlled trial to assess the impact of Target Inhalation Mode (TIM) aerosol delivery on the treatment time with nebulised antibiotic therapy in children with Cystic Fibrosis

Alder Hey Children's NHS Foundation Trust (UK)0 sites20 target enrollmentApril 7, 2011
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Alder Hey Children's NHS Foundation Trust (UK)
Enrollment
20
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 7, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Alder Hey Children's NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients with a valid diagnosis (sweat chloride \> 60 or two CF causing gene mutations)
  • •2\. Airway infection with Pseudomonas aeruginosa requiring long term nebulised Colistin therapy
  • •3\. Established on standard Tidal Breathing Mode of delivery using AAD device for Colistin therapy
  • •4\. Ability to comprehend use of the TIM device and follow instruction
  • •5\. Aged more than or equal to 5 years and able to perform lung function
  • •6\. No recent (\> 6 weeks) exacerbation of chest condition as defined by
  • •6\.1\. A deterioration forced expiratory volume in one second (FEV1\) more than or equal to 10% from previously recorded value
  • •6\.2\. Cough
  • •6\.3\. Change in sputum production

Exclusion Criteria

  • •1\. Patient with first growth of Pseudomonas aeruginosa requiring short term (3 months) colistin therapy
  • •2\. Patients prescribed alternate month TOBI and Colistin nebulised therapy
  • •3\. Patients with an acute exacerbation respiratory symptoms

Outcomes

Primary Outcomes

Not specified

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