NCT02683668

Airway Effects of Tiotropium in Patients With COPD

Completed Phase 3 Results posted Last updated 29 August 2025

What this trial tests

Phase 3 trial testing Handihaler-Tiotropium 18 mcg untrained in COPD in 44 participants. Completed in 1 January 2018.

Timeline

1 February 2016

Primary endpoint
1 January 2018

1 January 2018

Quick facts

Lead sponsor	Imperial College London
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	1 February 2016
Primary completion	1 January 2018
Estimated completion	1 January 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Handihaler-Tiotropium 18 mcg untrained
• Handihaler-Tiotropium 18 mcg trained
• Respimat-Tiotropium 5 mcg trained

Conditions studied

• COPD — all drugs for COPD →
• LUNG DISEASES, OBSTRUCTIVE — all drugs for LUNG DISEASES, OBSTRUCTIVE →

Sponsor

Imperial College London

Who can join

30 and older, any sex, with COPD or LUNG DISEASES, OBSTRUCTIVE. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Peripheral Airways Resistance (R5-R20) Primary · 28 days

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.

Group	Value	95% CI
Handihaler-Tiotropium 18 mcg Untrained	0.23	0.004 – 0.56
Handihaler-Tiotropium 18 mcg Trained	0.2	0.03 – 0.62
Respimat-Tiotropium 5 mcg Trained	0.16	0.03 – 0.42

Sacin Secondary · 28 days

Multiple Breath Nitrogen Washout (MBNW). Sacin is a gas exchange measures, assessing convectional ventilation heterogeneity in pre acinar/acinar airways.

Group	Value	95% CI
Handihaler-Tiotropium 18 mcg Untrained	0.333	0.11 – 0.53
Handihaler-Tiotropium 18 mcg Trained	0.339	0.06 – 0.57
Respimat-Tiotropium 5 mcg Trained	0.345	0.03 – 0.65

Lung Function FEV1 Secondary · 28 days

Lung function parameters FEV1

Group	Value	95% CI
Handihaler-Tiotropium 18 mcg Untrained	1.575	0.72 – 2.67
Handihaler-Tiotropium 18 mcg Trained	1.58	0.51 – 2.56
Respimat-Tiotropium 5 mcg Trained	1.651	0.74 – 2.65

Scond Secondary · 28 days

MBW parameters. Scond is a gas exchange measures, assessing convectional ventilation heterogeneity in peripheral conducting airways.

Group	Value	95% CI
Handihaler-Tiotropium 18 mcg Untrained	0.05	0.011 – 0.17
Handihaler-Tiotropium 18 mcg Trained	0.04	0.01 – 0.12
Respimat-Tiotropium 5 mcg Trained	0.04	0 – 0.12

Sponsor's own description

The aim of the study is to investigate the effect of tiotropium from different devices on a panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients with mild-moderate COPD. Comparisons will be made between Tiotropium Handihaler 18 micrograms once daily and Tiotropium Respimat 5 micrograms once daily

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Whole lung directed anti-muscarinic therapy improves small airway dysfunction in COPD patients.
   Usmani OS, Toumpanakis D, Meah S, Mak V, et al · · 2026 · PMID 41309266 · DOI 10.1183/13993003.01326-2025