Trial Outcomes & Findings for Airway Effects of Tiotropium in Patients With COPD (NCT NCT02683668)
NCT ID: NCT02683668
Last Updated: 2025-08-29
Results Overview
Peripheral airways resistance measured by impulse oscillometry (IOS). Specific frequencies relate to different levels: a frequency of 5 hertz (Hz) provides values for total airway resistance (R5) and reactance (X5); a 20Hz frequency gives a value for central or large airway resistance (R20); and if one subtracts the value of central airway resistance from that for total airway resistance (i.e. R5-R20), this provides a measure of peripheral or small airways resistance.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
28 days
Results posted on
2025-08-29
Participant Flow
Forty-four subjects (23 male) with mild-to-moderate COPD (GOLD stage I-II, FEV1 67.8% of predicted) using DPI-HandiHaler (18µg tiotropium daily) for at least 3 months, but with ongoing symptoms or exercise limitation (COPD Assesment Test (CAT) score \>10) participated in the study. 1 failed to complete
Participant milestones
| Measure |
Handihaler-Tiotropium 18 mcg Untrained
Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use. Here the investigators want to see that if patients have on-going symptoms but are on Handihaler-Tiotropium 18mcg what is happening PRIOR to proper inhaler technique training - that is their 'real-life' use of the inhaler - to their lung function (large and small airways) and also symptoms or exercise limitation (determined by CAT score) will already be recorded as entry criteria
Handihaler-Tiotropium 18 mcg untrained: We are looking at the untrained used of Handihaler
|
Handihaler-Tiotropium 18 mcg Trained
Patients will be trained in their use of Handihaler-Tiotropium and asked to take 18 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER proper inhaler technique training on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score)
Handihaler-Tiotropium 18 mcg trained: We are looking at the trained use of Handihaler after 14 days treatment
|
Respimat-Tiotropium 5 mcg Trained
Patients will be switched to trained Respimat Tiotropium 5 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER this efficient device Respimat (trained) compared to PREVIOUS device Handihaler (trained) on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score). The investigators want to see if the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) can improve small airway measures (and indeed large airway measures) that might also be related to an improvement in symptoms.
Respimat-Tiotropium 5 mcg trained: we are looking at the trained use of Respimat after 14 days treatment
|
|---|---|---|---|
|
Period 1
STARTED
|
44
|
0
|
0
|
|
Period 1
COMPLETED
|
44
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
44
|
0
|
|
Period 2
COMPLETED
|
0
|
43
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
0
|
|
Period 3
STARTED
|
0
|
0
|
43
|
|
Period 3
COMPLETED
|
0
|
0
|
43
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Handihaler-Tiotropium 18 mcg Untrained
Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use. Here the investigators want to see that if patients have on-going symptoms but are on Handihaler-Tiotropium 18mcg what is happening PRIOR to proper inhaler technique training - that is their 'real-life' use of the inhaler - to their lung function (large and small airways) and also symptoms or exercise limitation (determined by CAT score) will already be recorded as entry criteria
Handihaler-Tiotropium 18 mcg untrained: We are looking at the untrained used of Handihaler
|
Handihaler-Tiotropium 18 mcg Trained
Patients will be trained in their use of Handihaler-Tiotropium and asked to take 18 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER proper inhaler technique training on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score)
Handihaler-Tiotropium 18 mcg trained: We are looking at the trained use of Handihaler after 14 days treatment
|
Respimat-Tiotropium 5 mcg Trained
Patients will be switched to trained Respimat Tiotropium 5 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER this efficient device Respimat (trained) compared to PREVIOUS device Handihaler (trained) on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score). The investigators want to see if the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) can improve small airway measures (and indeed large airway measures) that might also be related to an improvement in symptoms.
Respimat-Tiotropium 5 mcg trained: we are looking at the trained use of Respimat after 14 days treatment
|
|---|---|---|---|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participant
n=44 Participants
Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=44 Participants
|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 8.0 • n=44 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=44 Participants
|
|
Region of Enrollment
United Kingdom
|
44 participants
n=44 Participants
|
|
R5 - R20 (Peripheral Airways Resistance)
|
0.608 kPa/l/s
STANDARD_DEVIATION 0.207 • n=44 Participants
|
PRIMARY outcome
Timeframe: 28 daysPeripheral airways resistance measured by impulse oscillometry (IOS). Specific frequencies relate to different levels: a frequency of 5 hertz (Hz) provides values for total airway resistance (R5) and reactance (X5); a 20Hz frequency gives a value for central or large airway resistance (R20); and if one subtracts the value of central airway resistance from that for total airway resistance (i.e. R5-R20), this provides a measure of peripheral or small airways resistance.
Outcome measures
| Measure |
Handihaler-Tiotropium 18 mcg Untrained
n=44 Participants
Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use. Here the investigators want to see that if patients have on-going symptoms but are on Handihaler-Tiotropium 18mcg what is happening PRIOR to proper inhaler technique training - that is their 'real-life' use of the inhaler - to their lung function (large and small airways) and also symptoms or exercise limitation (determined by CAT score) will already be recorded as entry criteria
Handihaler-Tiotropium 18 mcg untrained: We are looking at the untrained used of Handihaler
|
Handihaler-Tiotropium 18 mcg Trained
n=43 Participants
Patients will be trained in their use of Handihaler-Tiotropium and asked to take 18 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER proper inhaler technique training on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score)
Handihaler-Tiotropium 18 mcg trained: We are looking at the trained use of Handihaler after 14 days treatment
|
Respimat-Tiotropium 5 mcg Trained
n=43 Participants
Patients will be switched to trained Respimat Tiotropium 5 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER this efficient device Respimat (trained) compared to PREVIOUS device Handihaler (trained) on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score). The investigators want to see if the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) can improve small airway measures (and indeed large airway measures) that might also be related to an improvement in symptoms.
Respimat-Tiotropium 5 mcg trained: we are looking at the trained use of Respimat after 14 days treatment
|
|---|---|---|---|
|
Peripheral Airways Resistance (R5-R20)
|
0.23 kPa/l/s
Interval 0.004 to 0.56
|
0.2 kPa/l/s
Interval 0.03 to 0.62
|
0.16 kPa/l/s
Interval 0.03 to 0.42
|
SECONDARY outcome
Timeframe: 28 daysMultiple Breath Nitrogen Washout (MBNW). Sacin is a gas exchange measures, assessing convectional ventilation heterogeneity in pre acinar/acinar airways.
Outcome measures
| Measure |
Handihaler-Tiotropium 18 mcg Untrained
n=44 Participants
Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use. Here the investigators want to see that if patients have on-going symptoms but are on Handihaler-Tiotropium 18mcg what is happening PRIOR to proper inhaler technique training - that is their 'real-life' use of the inhaler - to their lung function (large and small airways) and also symptoms or exercise limitation (determined by CAT score) will already be recorded as entry criteria
Handihaler-Tiotropium 18 mcg untrained: We are looking at the untrained used of Handihaler
|
Handihaler-Tiotropium 18 mcg Trained
n=43 Participants
Patients will be trained in their use of Handihaler-Tiotropium and asked to take 18 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER proper inhaler technique training on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score)
Handihaler-Tiotropium 18 mcg trained: We are looking at the trained use of Handihaler after 14 days treatment
|
Respimat-Tiotropium 5 mcg Trained
n=43 Participants
Patients will be switched to trained Respimat Tiotropium 5 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER this efficient device Respimat (trained) compared to PREVIOUS device Handihaler (trained) on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score). The investigators want to see if the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) can improve small airway measures (and indeed large airway measures) that might also be related to an improvement in symptoms.
Respimat-Tiotropium 5 mcg trained: we are looking at the trained use of Respimat after 14 days treatment
|
|---|---|---|---|
|
Sacin
|
0.333 kPa\l\s
Interval 0.11 to 0.53
|
0.339 kPa\l\s
Interval 0.06 to 0.57
|
0.345 kPa\l\s
Interval 0.03 to 0.65
|
SECONDARY outcome
Timeframe: 28 daysLung function parameters FEV1
Outcome measures
| Measure |
Handihaler-Tiotropium 18 mcg Untrained
n=44 Participants
Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use. Here the investigators want to see that if patients have on-going symptoms but are on Handihaler-Tiotropium 18mcg what is happening PRIOR to proper inhaler technique training - that is their 'real-life' use of the inhaler - to their lung function (large and small airways) and also symptoms or exercise limitation (determined by CAT score) will already be recorded as entry criteria
Handihaler-Tiotropium 18 mcg untrained: We are looking at the untrained used of Handihaler
|
Handihaler-Tiotropium 18 mcg Trained
n=43 Participants
Patients will be trained in their use of Handihaler-Tiotropium and asked to take 18 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER proper inhaler technique training on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score)
Handihaler-Tiotropium 18 mcg trained: We are looking at the trained use of Handihaler after 14 days treatment
|
Respimat-Tiotropium 5 mcg Trained
n=43 Participants
Patients will be switched to trained Respimat Tiotropium 5 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER this efficient device Respimat (trained) compared to PREVIOUS device Handihaler (trained) on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score). The investigators want to see if the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) can improve small airway measures (and indeed large airway measures) that might also be related to an improvement in symptoms.
Respimat-Tiotropium 5 mcg trained: we are looking at the trained use of Respimat after 14 days treatment
|
|---|---|---|---|
|
Lung Function FEV1
|
1.575 liters
Interval 0.72 to 2.67
|
1.58 liters
Interval 0.51 to 2.56
|
1.651 liters
Interval 0.74 to 2.65
|
SECONDARY outcome
Timeframe: 28 daysMBW parameters. Scond is a gas exchange measures, assessing convectional ventilation heterogeneity in peripheral conducting airways.
Outcome measures
| Measure |
Handihaler-Tiotropium 18 mcg Untrained
n=44 Participants
Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use. Here the investigators want to see that if patients have on-going symptoms but are on Handihaler-Tiotropium 18mcg what is happening PRIOR to proper inhaler technique training - that is their 'real-life' use of the inhaler - to their lung function (large and small airways) and also symptoms or exercise limitation (determined by CAT score) will already be recorded as entry criteria
Handihaler-Tiotropium 18 mcg untrained: We are looking at the untrained used of Handihaler
|
Handihaler-Tiotropium 18 mcg Trained
n=43 Participants
Patients will be trained in their use of Handihaler-Tiotropium and asked to take 18 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER proper inhaler technique training on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score)
Handihaler-Tiotropium 18 mcg trained: We are looking at the trained use of Handihaler after 14 days treatment
|
Respimat-Tiotropium 5 mcg Trained
n=43 Participants
Patients will be switched to trained Respimat Tiotropium 5 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER this efficient device Respimat (trained) compared to PREVIOUS device Handihaler (trained) on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score). The investigators want to see if the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) can improve small airway measures (and indeed large airway measures) that might also be related to an improvement in symptoms.
Respimat-Tiotropium 5 mcg trained: we are looking at the trained use of Respimat after 14 days treatment
|
|---|---|---|---|
|
Scond
|
0.05 kPa\l\s
Interval 0.011 to 0.17
|
0.04 kPa\l\s
Interval 0.01 to 0.12
|
0.04 kPa\l\s
Interval 0.0 to 0.12
|
Adverse Events
All Participant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place