To assess the impact of Target Inhalation Mode (TIM) aerosol delivery on the treatment time with nebulised antibiotic therapy in children with Cystic Fibrosis

Completed

• Conditions: Cystic Fibrosis; Nutritional, Metabolic, Endocrine; Cystic fibrosis

• Registration Number: ISRCTN65617839
• Lead Sponsor: Alder Hey Children's NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified