Fine-Mist inhalers aim to reach deep lungs in COPD
NCT ID NCT01721291
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests whether a fine-mist inhaler can deliver salbutamol deeper into the lungs than standard inhalers. People with COPD, asthma, and healthy volunteers inhale salbutamol in different particle sizes, some tagged with a radioactive tracer to track where the drug lands. Researchers use imaging and breathing tests to see if the fine mist reaches the small airways and improves breathing. The goal is to guide development of more efficient inhalers for COPD.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Salbutamol (albuterol) delivered as a fine-mist aerosol via a special generator, compared with a standard metered-dose inhaler
- What this could lead to
- If fine-mist droplets reach deeper airways, this could lead to more effective inhalers that better relieve breathlessness in COPD and asthma.
- What could go wrong
- This is a small early-phase study, so results may not apply to all patients. The fine-mist approach might not improve breathing enough to matter in daily life.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
64 people
The number who actually took part.
- Started
-
Oct 2012
- Finished
-
Nov 2017
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- COPD patients, either male or female, over the age of 40 with a clinical diagnosis of COPD with airflow obstruction(FEV1/FVC\<0.7) and post-bronchodilator FEV1\>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: 1. Oral corticosteroids taken within last month. 2. Current involvement (or involvement in the last 4 weeks)in clinical trials assessing investigational medicinal products. 3. Previous adverse reaction to short or long acting β2 agonist. 4. 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. 5. Those who have experienced an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit). 6. Pregnant or breastfeeding women. 7. Subjects unable to give Informed Consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Royal Brompton Hospital & Imperial College London
London, London, SW3 6LY, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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