CHRONIC OBSTRUCTIVE PULMONARY DISEASEPhase 4NCT01721291

Inhaler Lung Deposition in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study testing SALBUTAMOL in people with CHRONIC OBSTRUCTIVE PULMONARY DISEASE and ASTHMA, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA, HEALTHY SUBJECTS
What is being tested?: SALBUTAMOL
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Oct 2012to 27 Nov 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Royal Brompton Hospital & Imperial College London
London, London, SW3 6LY

Other trials in United Kingdom

About this study

Official title: Improving Inhaler Treatment and Small Airways Assessment in Chronic Obstructive Pulmonary Disease (COPD)

In the first part of the study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive tracer to track lung deposition in participants with COPD as well as Healthy participants. We will acquire images of the lungs with a gamma camera and calculate the Penetration Index (PI) to see if the fine-mist droplets reach the deep airways, and assess if this improves the breathing capacity in the COPD participants. Our research may allow the development of new, more efficient inhalers to improve treatment for patients with COPD.

Read the detailed description

PURPOSE:

The purpose of the research (or "knowledge gap" this research is designed to fill) is to understand the fate of inhaled drug within the lungs of COPD patients. Current inhalers in use were developed to treat asthma, which is predominantly a disease of the large airways, and these inhalers may not be optimal in treating COPD patients (which is predominantly a disease of the small airways). Poor delivery of inhaled bronchodilators to the peripheral deep airways may be a major factor limiting the clinical benefit provided by existing devices. The key to successful treatment could be to accurately target inhaled drug to the diseased lung sites, which is the hypothesis that this protocol will test.

DESIGN \& FUNDING:

Dr Omar Usmani has developed the research protocol and the study has been funded by the UK Government Department of Health through the NIHR (National Institute for Health Research), which funds leading edge research in the NHS focussed on the needs of patients and the public and aims to improve the health and wealth of the nation through research. The study has been peer reviewed by International Experts in this field of research.

PROTOCOL:

This protocol has two studies: Lung DEPOSITION study (in COPD patients and Healthy subjects) and Lung PHYSIOLOGY study (in COPD patients and Asthmatics).

Each study (Lung DEPOSITION and Lung PHYSIOLOGY) will be have 7 randomized crossover treatments. A special aerosol generator called a Spinning Top Aerosol Generator (STAG), here referred to as a Research Nebuliser, is used to generate monodisperse aerosol droplets (aerosols that have a very narrow spread of particles sizes, such that they can be considered to be one size).

Treatments will be given as one off dose administration. There will be an interval of at least 5 days between each study visit. The Lung DEPOSITION study will involve radiolabelled drug treatments .

All the treatments in the LUNG PHYSIOLOGY study will be non-radiolabelled. Salbutamol will be the drug aerosol administered to each subject at each visit. Subjects and investigators will be blinded to the 'fine-mist' aerosol particle sizes given (at 6 treatments). The control arm will be salbutamol drug aerosol delivered as a 'coarse mist' standard metered dose inhaler (7th treatment visit).

RECRUITMENT/SAMPLE SIZE; The study will recruit; Lung DEPOSITION study: 12 mild-moderate COPD patients, 12 healthy subjects Lung PHYSIOLOGY study: 26 mild-moderate COPD patients, 12 mild-moderate asthmatic patients

INCLUSION / EXCLUSION:

At the screening vist, no one will be unfairly excluded from the research, particularly as COPD is a disease of older age and those over 65 should not be discriminated against. This research will therefore reflect the 'real world' of COPD.

Conditions: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA, HEALTHY SUBJECTS
Being tested: SALBUTAMOL
Keywords: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA, SALBUTAMOL, ALBUTEROL, VENTOLIN, LUNG PHYSIOLOGY, LUNG DEPOSITION, INHALERS, DRUG THERAPY
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SALBUTAMOLDrug
Also called ALBUTEROL; VENTOLIN; SALMOL
SALBUTAMOL is inhaled VIA the Spinning Top Aerosol Generator (STAG) at 3 particle size 1.5 microns, 3 microns and 6 microns.
In the LUNG DEPOSITION study radiolabeled salbutamol is given at slow and fast inhalations at a dosage of 30 micrograms, In addition , 200 MICROGRAMS of salbutamol will be inhaled via a standard metered dose inhaler (MDI). These are given in randomized order.
In the LUNG PHYSIOLOGY STUDY, unlabeled SALBUTAMOL is given at slow inhalation via the Spinning Top Aerosol Generator (STAG)at 2 different doses (30 micrograms and 15 micrograms)

Study groups in NCT01721291
Study group	Role	What they receive
Lung Deposition study COPD 1	Experimental	Subjects from COPD group 1 receive 6 radiolabeled treatments of 30mcg salbutamol of 1.5, 3.0 and 6.0 micron sized aerosols + 1 dose of 200mcg salbutamol from an MDI, in randomized crossover order. Receives: Drug: SALBUTAMOL
Lung Deposition study Healthy subjects	Experimental	Healthy subjects receive 6 radiolabeled treatments of 30mcg salbutamol of 1.5, 3.0 and 6.0 micron sized aerosols + 1 dose of 200mcg salbutamol from an MDI, in randomized crossover order. Receives: Drug: SALBUTAMOL
Lung Physiology study COPD 2	Experimental	COPD subjects group 2 receive 6 treatments of 30mcg salbutamol of 1.5, 3.0 and 6.0 micron sized aerosols + 1 dose of 200mcg salbutamol from an MDI, in randomized crossover order. All does are non-radiolabeled. Receives: Drug: SALBUTAMOL
Lung Physiology study Asthmatics	Experimental	Asthmatic subjects group 2 receive 6 treatments of 30mcg salbutamol of 1.5, 3.0 and 6.0 micron sized aerosols + 1 dose of 200mcg salbutamol from an MDI, in randomized crossover order. All does are non-radiolabeled. Receives: Drug: SALBUTAMOL

What is being measured

The primary outcome is the main question the study is designed to answer.

Penetration Index (LUNG DEPOSITION STUDY)
Images of the lungs were acquired using gamma scintigraphy. Monodisperse salbutamol aerosols were radiolabeled with the radioisotope Technetium-99m (Tc99m). The images were processed using computer software and the lung images divided into central airways (C - region) and peripheral airways (P -region). We analyzed the amount of radiolabeled salbutamol in each region and calculated how deep into the lungs the inhaled salbutamol has reached by using the ratio C/P which is known as the Penetration Index. More precisely, the regional lung distribution was expressed as penetration index: the ratio of radioaerosol counts in the peripheral zone to the central lung zones divided by the same count ratio from a Krypton ventilation scan. No data is shown for the MDI metered dose inhaler (MDI) treatment as the drug inside the canister was not radiolabeled. This treatemnt was not undertaken by the COPD 2 and asthma groups.
Measured: 5 MINUTES AFTER INHALATION OF SALBUTAMOL
Scond - MBNW (LUNG PHYSIOLOGY STUDY)
This section is reporting data only for the Lung Physiology Study (the results for the Lung Deposition Study have been reported in the previous sections).
Measure of ventilation heterogeneity in conducting airways (measures relate to the peripheral lung compartment conducting airways, which are non-gas-exchanging i.e. Scond). For the COPD 2 group, the measurements are made 30 minutes after the participant has inhaled either 15mcg or 30 mcg of salbutamol inhaled slowly at 1.5um, 3um, or 6um aerosol particle size and 200 mcg from MDI. For the Asthma group measures are made after inhaling only 30mcg of salbutamol inhaled slowly at 1.5um, 3um, or 6um aerosol particle size and 200mcg from MDI. The asthma group was not given the 15mcg dose.
MBNW stands for Multiple Breath Nitrogen Washout.
Measured: 30 minutes after salbutamol
Sacin - MBNW (LUNG PHYSIOLOGY STUDY)
This section is reporting data only for the Lung Physiology Study (the results for the Lung Deposition Study have been reported in the following section). Measure of ventilation heterogeneity in conducting airways (measures relate to the peripheral lung acinar compartment conducting airways, which are gas-exchanging i.e. Sacin). COPD 2 - The measurements are made 30 minutes after the participant has inhaled either 15mcg or 30 mcg of salbutamol inhaled slowly at 1.5um, 3um, or 6um aerosol particle size and 200 mcg from MDI. For the Asthma group measures are made 30 minutes after inhaling only 30mcg of salbutamol inhaled slowly at 1.5um, 3um, or 6um aerosol particle size and 200mcg from MDI. The 15mcg dose is not given, as outlined in the protocol.
MBNW stands for Multiple Breath Nitrogen Washout
Measured: 30 minutes after inhaling salbutamol

Secondary outcomes (2)

Scond - MBNW (LUNG DEPOSITION STUDY)
This section is reporting data only for the Lung Deposition Study (the results for the Lung Physiology Study have been reported in the previous sections). Here Scond is a seconadry measure. Scond is a measure of Ventilation heterogeneity in the conducting airways (measures relate to the peripheral lung compartment conducting airways, which are non-gas-exchanging i.e. Scond). No MBNW measurements were made for the Healthy subjects Multiple Breath Nitrogen analysis (MBNW).
Measured: 30 minutes after inhaling salbutamol
Sacin (MBNW) (LUNG DEPOSITION STUDY)
This section is reporting data only for the Lung Deposition Study (the results for the Lung Physiology Study have been reported in the previous sections). Here Sacin is a seconadry measure. Sacin is a measure of Ventilation heterogeneity in the acinar airways (measures relate to the peripheral lung compartment conducting airways). No MBNW measurements were made for the Healthy subjects Multiple Breath Nitrogen analysis (MBNW).
Measured: 30 minutes after inhaling salbutamol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201227 Nov 2017

First posted5 Nov 2012 (estimated)
Study start1 Oct 2012
Primary completion27 Nov 2017
Study completion27 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CHRONIC OBSTRUCTIVE PULMONARY DISEASEStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Crossover is within each of the groups., ie COPD1, Healthy, COPD2, Asthma ( 6 interventions each)
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01721291
Sponsor's protocol ID: NIHRCDF
Other IDs: NIHR-CDF-2011-04-053, 2011-005544-10
Status last verified: Sep 2026
First submitted: 16 Oct 2012
Last updated: 3 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28.
PubMed 16192448

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Inhaler Treatment and Small Airways Assessment in Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01721291
Acronym / sponsor ID: NIHRCDF
Conditions: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA, HEALTHY SUBJECTS
Keywords: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA, SALBUTAMOL, ALBUTEROL, VENTOLIN, LUNG PHYSIOLOGY, LUNG DEPOSITION, INHALERS
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: National Institute for Health Research, United Kingdom
Study start: 1 Oct 2012 (actual)
Primary completion: 27 Nov 2017 (actual)
Study completion: 27 Nov 2017 (actual)
First posted: 5 Nov 2012 (estimated)
Results: Posted 6 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PURPOSE:

DESIGN \& FUNDING:

PROTOCOL:

This protocol has two studies: Lung DEPOSITION study (in COPD patients and Healthy subjects) and Lung PHYSIOLOGY study (in COPD patients and Asthmatics).

Treatments will be given as one off dose administration. There will be an interval of at least 5 days between each study visit. The Lung DEPOSITION study will involve radiolabelled drug treatments .

INCLUSION / EXCLUSION:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: Crossover is within each of the groups., ie COPD1, Healthy, COPD2, Asthma ( 6 interventions each)

Arm	Type	Receives
Lung Deposition study COPD 1	Experimental	Drug: SALBUTAMOLSubjects from COPD group 1 receive 6 radiolabeled treatments of 30mcg salbutamol of 1.5, 3.0 and 6.0 micron sized aerosols + 1 dose of 200mcg salbutamol from an MDI, in randomized crossover order.
Lung Deposition study Healthy subjects	Experimental	Drug: SALBUTAMOLHealthy subjects receive 6 radiolabeled treatments of 30mcg salbutamol of 1.5, 3.0 and 6.0 micron sized aerosols + 1 dose of 200mcg salbutamol from an MDI, in randomized crossover order.
Lung Physiology study COPD 2	Experimental	Drug: SALBUTAMOLCOPD subjects group 2 receive 6 treatments of 30mcg salbutamol of 1.5, 3.0 and 6.0 micron sized aerosols + 1 dose of 200mcg salbutamol from an MDI, in randomized crossover order. All does are non-radiolabeled.
Lung Physiology study Asthmatics	Experimental	Drug: SALBUTAMOLAsthmatic subjects group 2 receive 6 treatments of 30mcg salbutamol of 1.5, 3.0 and 6.0 micron sized aerosols + 1 dose of 200mcg salbutamol from an MDI, in randomized crossover order. All does are non-radiolabeled.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SALBUTAMOLAlso: ALBUTEROL; VENTOLIN; SALMOLSALBUTAMOL is inhaled VIA the Spinning Top Aerosol Generator (STAG) at 3 particle size 1.5 microns, 3 microns and 6 microns. In the LUNG DEPOSITION study radiolabeled salbutamol is given at slow and fast inhalations at a dosage of 30 micrograms, In addition , 200 MICROGRAMS of salbutamol will be inhaled via a standard metered dose inhaler (MDI). These are given in randomized order. In the LUNG PHYSIOLOGY STUDY, unlabeled SALBUTAMOL is given at slow inhalation via the Spinning Top Aerosol Generator (STAG)at 2 different doses (30 micrograms and 15 micrograms)	Drug	Lung Deposition study COPD 1, Lung Deposition study Healthy subjects, Lung Physiology study Asthmatics, Lung Physiology study COPD 2

Primary outcome

Penetration Index (LUNG DEPOSITION STUDY)
Time frame: 5 MINUTES AFTER INHALATION OF SALBUTAMOL
Images of the lungs were acquired using gamma scintigraphy. Monodisperse salbutamol aerosols were radiolabeled with the radioisotope Technetium-99m (Tc99m). The images were processed using computer software and the lung images divided into central airways (C - region) and peripheral airways (P -region). We analyzed the amount of radiolabeled salbutamol in each region and calculated how deep into the lungs the inhaled salbutamol has reached by using the ratio C/P which is known as the Penetration Index. More precisely, the regional lung distribution was expressed as penetration index: the ratio of radioaerosol counts in the peripheral zone to the central lung zones divided by the same count ratio from a Krypton ventilation scan. No data is shown for the MDI metered dose inhaler (MDI) treatment as the drug inside the canister was not radiolabeled. This treatemnt was not undertaken by the COPD 2 and asthma groups.
Scond - MBNW (LUNG PHYSIOLOGY STUDY)
Time frame: 30 minutes after salbutamol
This section is reporting data only for the Lung Physiology Study (the results for the Lung Deposition Study have been reported in the previous sections). Measure of ventilation heterogeneity in conducting airways (measures relate to the peripheral lung compartment conducting airways, which are non-gas-exchanging i.e. Scond). For the COPD 2 group, the measurements are made 30 minutes after the participant has inhaled either 15mcg or 30 mcg of salbutamol inhaled slowly at 1.5um, 3um, or 6um aerosol particle size and 200 mcg from MDI. For the Asthma group measures are made after inhaling only 30mcg of salbutamol inhaled slowly at 1.5um, 3um, or 6um aerosol particle size and 200mcg from MDI. The asthma group was not given the 15mcg dose. MBNW stands for Multiple Breath Nitrogen Washout.
Sacin - MBNW (LUNG PHYSIOLOGY STUDY)
Time frame: 30 minutes after inhaling salbutamol
This section is reporting data only for the Lung Physiology Study (the results for the Lung Deposition Study have been reported in the following section). Measure of ventilation heterogeneity in conducting airways (measures relate to the peripheral lung acinar compartment conducting airways, which are gas-exchanging i.e. Sacin). COPD 2 - The measurements are made 30 minutes after the participant has inhaled either 15mcg or 30 mcg of salbutamol inhaled slowly at 1.5um, 3um, or 6um aerosol particle size and 200 mcg from MDI. For the Asthma group measures are made 30 minutes after inhaling only 30mcg of salbutamol inhaled slowly at 1.5um, 3um, or 6um aerosol particle size and 200mcg from MDI. The 15mcg dose is not given, as outlined in the protocol. MBNW stands for Multiple Breath Nitrogen Washout

2 secondary outcomes

Scond - MBNW (LUNG DEPOSITION STUDY)
Time frame: 30 minutes after inhaling salbutamol
Sacin (MBNW) (LUNG DEPOSITION STUDY)
Time frame: 30 minutes after inhaling salbutamol

Results and safety

Results posted to the registry on 6 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COPD 1- Lung DEPOSITION Study	14	14
Healthy - Lung DEPOSITION Study	12	12
COPD 2 - Lung PHYSIOLOGY Study	26	26
Asthma Lung PHYSIOLOGY Study	12	12

Primary outcome: Penetration Index (LUNG DEPOSITION STUDY)

Time frame: 5 MINUTES AFTER INHALATION OF SALBUTAMOL. Mean (Full Range). Unit: ratio

Measure	COPD 1 n = 12	Healthy n = 12	COPD 2 n = 0	Asthma n = 0
1.5micron (30 mcg) slow	0.69 (0.13)	0.8 (0.08)	–	–
1.5micron (30 mcg) fast	0.58 (0.14)	0.72 (0.12)	–	–
3micron (30 mcg) slow	0.65 (0.18)	0.75 (0.11)	–	–
3micron (30 mcg) fast	0.48 (0.16)	0.63 (0.15)	–	–
6micron (30mcg) slow	0.37 (0.12)	0.51 (0.1)	–	–
6micron (30 mcg) fast	0.32 (0.08)	0.46 (0.04)	–	–

Population analysed: The Penetration Index (PI) was only measured for the Healthy Volunteers and COPD participants from Group 1 (Lung Deposition study). The Lung PHYSIOLOGY arms, COPD2 and the asthma group, did not receive this treatment (radiolabelled salbutamol ). This is the reason that there are 0 values shown here for these groups. PI is a ratio and has no units. The PI was also not measured for the MDI as it was not possible o add a radiolabel to drug inside the MDI canister.

Primary outcome: Scond - MBNW (LUNG PHYSIOLOGY STUDY)

Time frame: 30 minutes after salbutamol. Mean (Full Range). Unit: 1/l

Measure	COPD 1 n = 0	Healthy n = 0	COPD 2 n = 26	Asthma n = 12
1.5um (30 mcg)	–	–	0.068 (0.022 to 0.207)	0.068 (0.042 to 0.167)
1.5um (15 mcg)	–	–	0.078 (0.022 to 1.9)	–
3um (30mcg)	–	–	0.071 (0.022 to 0.22)	0.061 (0.024 to 0.127)
3um (15 mcg)	–	–	0.076 (0.022 to 0.156)	–
6um (30mcg)	–	–	0.063 (0.02 to 0.167)	0.066 (0.038 to 0.133)
6um (15 mcg)	–	–	0.084 (0.033 to 0.189)	–
MDI 200 mcg	–	–	0.061 (0.022 to 0.171)	0.059 (0.033 to 0.098)

Population analysed: Scond is a measure of ventilation heterogeneity in the conducting airways. It was a primary measure for the COPD 2 and asthma groups (Lung Physiology study), but a secondary measure for the COPD1 group and not measured for the Healthy group (Lung deposition study.

Primary outcome: Sacin - MBNW (LUNG PHYSIOLOGY STUDY)

Time frame: 30 minutes after inhaling salbutamol. Mean (Full Range). Unit: units on a scale

Measure	COPD 1 n = 0	Healthy n = 0	COPD 2 n = 26	Asthma n = 13
1.5um (30mcg)	–	–	0.582 (0.129 to 1.918)	0.132 (0.073 to 0.179)
1.5um (15mcg)	–	–	0.786 (0.224 to 1.918)	–
3um (30mcg)	–	–	0.605 (0.17 to 1.588)	0.134 (0.049 to 0.252)
3um (15mcg)	–	–	0.691 (0.12 to 1.323)	–
6um (30 mcg)	–	–	0.518 (0.157 to 1.167)	0.155 (0.074 to 0.290)
6um (15 mcg)	–	–	0.747 (0.166 to 1.551)	–
MDI 200mcg	–	–	0.494 (0.076 to 1.086)	0.141 (0.049 to 0.264)

Population analysed: Sacin is a measure of ventilation heterogeneity in the acinar and peripheral airawys. It is a primary measure for the COPD 2 and asthma groups (Lung physiology study) , but a secondary measure for the COPD1 group and not measured for the Healthy group (lung deposition study).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COPD 1- Lung DEPOSITION Study	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Healthy - Lung DEPOSITION Study	0 of 12 (0%)	0 of 12 (0%)	0 of 12
COPD 2 - Lung PHYSIOLOGY	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Asthma - Lung PHYSIOLOGY	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16192448Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28.
Individual participant dataSharing planned: No

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COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Omar S USMANI, MD, PhD principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SALBUTAMOL in people with CHRONIC OBSTRUCTIVE PULMONARY DISEASE and ASTHMA, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Penetration Index (LUNG DEPOSITION STUDY) (time frame: 5 MINUTES AFTER INHALATION OF SALBUTAMOL). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01721291, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.