Trial Outcomes & Findings for Inhaler Lung Deposition in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01721291)
NCT ID: NCT01721291
Last Updated: 2023-03-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
5 MINUTES AFTER INHALATION OF SALBUTAMOL
Results posted on
2023-03-06
Participant Flow
This protocol has two studies: Lung DEPOSITION study (in COPD patients and Healthy subjects) and Lung PHYSIOLOGY study (in COPD patients and Asthmatics).
Participant milestones
| Measure |
COPD- Lung DEPOSITION Study
Lung DEPOSITION study COPD patients All participant received SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER GIVEN AS A SINGLE INHALATION.
|
Healthy - Lung DEPOSITION Study
Lung DEPOSITION study
Healthy participants received:
SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER GIVEN AS A SINGLE INHALATION.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
COPD- Lung DEPOSITION Study
Lung DEPOSITION study COPD patients All participant received SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER GIVEN AS A SINGLE INHALATION.
|
Healthy - Lung DEPOSITION Study
Lung DEPOSITION study
Healthy participants received:
SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER GIVEN AS A SINGLE INHALATION.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
did not like the treatment
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
COPD
n=14 Participants
COPD patients
|
Healthy
n=12 Participants
Healthy participants
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=14 Participants
|
5 Participants
n=12 Participants
|
10 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=14 Participants
|
7 Participants
n=12 Participants
|
16 Participants
n=26 Participants
|
|
Age, Continuous
|
66.08 years
n=14 Participants
|
64.08 years
n=12 Participants
|
65.08 years
n=26 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
5 Participants
n=12 Participants
|
13 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
7 Participants
n=12 Participants
|
13 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=14 Participants
|
12 participants
n=12 Participants
|
65 participants
n=26 Participants
|
|
Force experation in 1s (FEV1)
|
1.63 litre
n=14 Participants
|
2.55 litre
n=12 Participants
|
2.12 litre
n=26 Participants
|
PRIMARY outcome
Timeframe: 5 MINUTES AFTER INHALATION OF SALBUTAMOLImages 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.
Outcome measures
| Measure |
Healthy_1.5um Slow
n=12 Participants
Healthy participants Salbutamol 1.5um slow
|
Healthy_1.5um Fast
n=12 Participants
Healthy participants Salbutamol 1.5um fast
|
COPD 1_1.5um Slow
n=12 Participants
COPD patients Salbutamol 1.5um slow
|
COPD1_1.5um Fast
n=12 Participants
Second group of COPD patients Salbutamol 1.5um fast
|
Healthy_3um Slow
n=12 Participants
Healthy participants Salbutamol 3um slow
|
Healthy_3um Fast
n=12 Participants
Healthy participants Salbutamol 3um fast
|
COPD_3um Slow
n=12 Participants
COPD patients Salbutamol 3um slow
|
COPD_3um Fast
n=12 Participants
COPD patients Salbutamol 3um fast
|
Healthy_6um Slow
n=12 Participants
Healthy participants Salbutamol 6um slow
|
Healthy_6um Fast
n=12 Participants
Healthy participants Salbutamol 6um fast
|
COPD_6um Slow
n=12 Participants
COPD patients Salbutamol 6um slow
|
COPD_6um Fast
n=12 Participants
COPD patients Salbutamol 6um fast
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ANALYSIS OF LUNG DEPOSITION - Penetration Index
|
0.8 ratio
Standard Deviation 0.08
|
0.72 ratio
Standard Deviation 0.12
|
0.69 ratio
Standard Deviation 0.13
|
0.58 ratio
Standard Deviation 0.14
|
0.75 ratio
Standard Deviation 0.11
|
0.63 ratio
Standard Deviation 0.15
|
0.65 ratio
Standard Deviation 0.18
|
0.48 ratio
Standard Deviation 0.16
|
0.51 ratio
Standard Deviation 0.1
|
0.46 ratio
Standard Deviation 0.04
|
0.37 ratio
Standard Deviation 0.12
|
0.32 ratio
Standard Deviation 0.08
|
Adverse Events
Healthy_1.5um Slow
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy_1.5um Fast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD_1.5um Slow
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
COPD_1.5um Fast
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy_3um Slow
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy_3um Fast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD_3um Slow
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
COPD_3um Fast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy_6um Slow
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy_6um Fast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD_6um Slow
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
COPD_6um Fast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy_1.5um Slow
n=12 participants at risk
Healthy participants received Salbutamol 1.5um slow - Lung DEPOSITION study
|
Healthy_1.5um Fast
n=12 participants at risk
Healthy participants received Salbutamol 1.5um fast - Lung DEPOSITION study
|
COPD_1.5um Slow
n=14 participants at risk
Participants with COPD received Salbutamol 1.5um slow - Lung DEPOSITION study
|
COPD_1.5um Fast
n=14 participants at risk
Participants with COPD received Salbutamol 1.5um fast - Lung DEPOSITION study
|
Healthy_3um Slow
n=12 participants at risk
Healthy participants received Salbutamol 3um slow - Lung DEPOSITION study
|
Healthy_3um Fast
n=12 participants at risk
Healthy participants received Salbutamol 3um fast - Lung DEPOSITION study
|
COPD_3um Slow
n=14 participants at risk
Participants with received COPD Salbutamol 3um slow - Lung DEPOSITION study
|
COPD_3um Fast
n=14 participants at risk
Participants with COPD Salbutamol 3um fast - Lung DEPOSITION study
|
Healthy_6um Slow
n=12 participants at risk
Healthy participants received Salbutamol 6um slow - Lung DEPOSITION study
|
Healthy_6um Fast
n=12 participants at risk
Healthy participants received Salbutamol 6um fast - Lung DEPOSITION study
|
COPD_6um Slow
n=14 participants at risk
Participants with COPD received Salbutamol 6um slow - Lung DEPOSITION study
|
COPD_6um Fast
n=14 participants at risk
Participants with COPD received Salbutamol 6um fast - Lung DEPOSITION study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
8.3%
1/12 • Number of events 1 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
|
Gastrointestinal disorders
Diarrhoe
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
7.1%
1/14 • Number of events 1 • 6 month
|
0.00%
0/14 • 6 month
|
|
Musculoskeletal and connective tissue disorders
Pulled muscle
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
7.1%
1/14 • Number of events 1 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
|
Infections and infestations
Chest infection
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
7.1%
1/14 • Number of events 1 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
|
Infections and infestations
Sore throat
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
|
Surgical and medical procedures
Cataract operatoin
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
8.3%
1/12 • Number of events 1 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
7.1%
1/14 • Number of events 1 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/12 • 6 month
|
0.00%
0/14 • 6 month
|
0.00%
0/14 • 6 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place