18 and older, any sex, with CHRONIC OBSTRUCTIVE PULMONARY DISEASE or ASTHMA. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
ANALYSIS OF LUNG DEPOSITION - Penetration IndexPrimary· 5 MINUTES AFTER INHALATION OF SALBUTAMOL
Images of the lungs will be taken for radiolabelled salbutamol treatment. The images will be processed using computer software and the lungs divided into central airways (C - region) and peripheral airways (P -region). We will analyse the amount of radiolabelled salbutamol in each region and calculate how deep into the lungs the inhaled salbutamol has reached by using the ratio C/P which is known as the Penetration Index.
Group
Value
95% CI
Healthy_1.5um Slow
0.8
± 0.08
Healthy_1.5um Fast
0.72
± 0.12
COPD 1_1.5um Slow
0.69
± 0.13
COPD1_1.5um Fast
0.58
± 0.14
Healthy_3um Slow
0.75
± 0.11
Healthy_3um Fast
0.63
± 0.15
COPD_3um Slow
0.65
± 0.18
COPD_3um Fast
0.48
± 0.16
Healthy_6um Slow
0.51
± 0.1
Healthy_6um Fast
0.46
± 0.04
COPD_6um Slow
0.37
± 0.12
COPD_6um Fast
0.32
± 0.08
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 month.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to provide relief from breathlessness. However, current inhalers are inefficient as they deliver a 'coarse-mist' of drug-droplets that do not reach the deep airways.
In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive tracer to track them. We will take images of the lungs to see if the fine-mist droplets reach the deep airways, and assess if this improves the breathing capacity in our patients. Our research may allow the development of new, more efficient inhalers to improve treatment for patients with COPD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Imperial College London
Last refreshed: 6 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01721291.