McCormack 2011.
| Study characteristics | |
| Methods | RCT Parallel group design Location: UK Duration: 4‐ to 6‐week run‐in period followed by an 8‐ to 10‐week intervention period |
| Participants | Clinically stable children with CF (5 to 16 years). Participants with Pseudomonas aeruginosa infection who were on long‐term (> 3 months) antibiotic therapy through the I‐neb using standard TBM of inhalation. 20 children randomised in total, 10 children to TIM and 10 to TBM. No dropouts or loss to follow‐up. Exclusion criteria: pulmonary exacerbation in the previous 4 weeks (defined as: increase in cough, increased sputum production, reduction in FEV1 > 10%). Baseline characteristics between the 2 groups were similar. One child in the TIM group had a fault with the base unit which was replaced during the course of the study. Age, median (range) TIM group: 11.7 years (8.7 to 15.9) TBM group: 10.6 years (5.2 to 16.9) Sex TIM group: 7 males, 3 females TBM group: 7 males, 3 females FEV1 % predicted, median (range) TIM group: 74% (60 to 105) TBM group: 80% (53 to 100) Schwachman score, median (range) TIM group: 85/100 (65 to 95) TBM group: 88/100 (60 to 100) AAD TBM therapy, mean (SD) duration prior to study TIM group: 42.2 months (10.4) TBM group: 34.7 months (12.5) |
| Interventions | Both groups used AAD via an I‐neb to deliver a commercial preparation of colistin (Promixin, Profile Pharma Ltd., Chichester, UK) with a standard treatment dose being 1 MU diluted in 2 mL normal saline (1 mL being used for each of 2 daily treatments). Some participants were prescribed a once‐daily dose of 1 MU colistin in 1 mL normal saline. Once‐daily dornase alfa (Pulmozyme) was also prescribed in several particpants. Schedule Both groups were given a run‐in period of 4 to 6 weeks on TBM, followed by 8 to 10 weeks of either TIM or TBM. Intervention group (AAD TIM) A high‐resistance mouthpiece guides the participant to use slower and deeper inhalations. The participant is encouraged to lengthen each inhalation by a vibratory feedback on the lip, which is the signal to exhale. TIM guides the participant into taking the longest inhalation they can manage by gradually increasing the time from the beginning of each breath to the vibration. Once the maximum length of inhalation has been found (i.e. when the patient is unable to reach the vibration), the time is then shortened to a comfortable level for the patient and remains at this level until the preset dose is achieved. Comparator (AAD TBM) Delivers aerosol particles of medication during tidal breathing. The I‐neb monitors the first 3 breaths and delivers a timed pulse of aerosol during the mid‐phase of the next inspiration. Each pulsed delivery is based on the previous 3 breaths. Audio and visual feedback is given when the treatment is complete. |
| Outcomes | Treatment adherence (% of expected treatments) FEV1 Adverse effects |
| Notes | Funding source: not stated |
AAD: adaptive aerosol delivery FEV1: forced expiratory volume in 1 second MU: mega unit RCT: randomised controlled trial TIM: target inhalation mode TBM: tidal breathing mode