Phase 4 Completed N=26 Randomized Triple-blind Treatment

Inhaler Lung Deposition in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease · Asthma · HEALTHY SUBJECTS

Source: ClinicalTrials.gov NCT01721291 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcomePrimary: ANALYSIS OF LUNG DEPOSITION - Penetration Index — 0.8; 0.72; 0.69; 0.58 ratio

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY ANALYSIS OF LUNG DEPOSITION - Penetration Index	0.8; 0.72; 0.69; 0.58; 0.75; 0.63	—

Eligibility Criteria

Inclusion Criteria

COPD patients, either male or female, over the age of 40 with a clinical diagnosis of COPD with airflow obstruction(FEV1/FVC 50% predicted, gas trapping (on lung volume testing), and decreased carbon monoxide transfer factor.

Healthy subjects will be nonsmokers(or exsmokers stopped 5 years ago), will have no respiratory disease, normal spirometry and be age-matched to the COPD patients.

Asthmatic subjects, either male or female, over the age of 18 with a clinical diagnosis of Asthma with airflow obstruction (FEV1/FVC<0.7).

All patients should be capable of giving informed consent.

Exclusion Criteria

Oral corticosteroids taken within last month.
Current involvement (or involvement in the last 4 weeks)in clinical trials assessing investigational medicinal products.
Previous adverse reaction to short or long acting β2 agonist.
Any subject with a contraindication to taking inhaled beta2-adrenoceptor agonists (especially salbutamol) as listed in the British National Formulary will not be entered into this study.
Those who have experienced an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit).
Pregnant or breastfeeding women.
Subjects unable to give Informed Consent.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01721291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.