Airway Effects of Tiotropium in Patients With COPD

NCT02683668 | Completed Phase 3 Results DMC

• 1 other identifier: 151C2697
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COPD; LUNG DISEASES, OBSTRUCTIVE

Keywords

Inhalers; Tiotropium

Outcome Measures

Primary Outcomes (1)

• Peripheral Airways Resistance (R5-R20)

  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.

  28 days

Secondary Outcomes (3)

• Sacin

  28 days

• Lung Function FEV1

  28 days

• Scond

  28 days

Study Arms (3)

Handihaler-Tiotropium 18 mcg untrained

EXPERIMENTAL

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

Combination Product: Handihaler-Tiotropium 18 mcg untrained

Handihaler-Tiotropium 18 mcg trained

EXPERIMENTAL

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)

Combination Product: Handihaler-Tiotropium 18 mcg trained

Respimat-Tiotropium 5 mcg trained

EXPERIMENTAL

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.

Combination Product: Respimat-Tiotropium 5 mcg trained

Interventions

Handihaler-Tiotropium 18 mcg untrained COMBINATION_PRODUCT

We are looking at the untrained used of Handihaler

Handihaler-Tiotropium 18 mcg untrained

Handihaler-Tiotropium 18 mcg trained COMBINATION_PRODUCT

We are looking at the trained use of Handihaler after 14 days treatment

Handihaler-Tiotropium 18 mcg trained

Respimat-Tiotropium 5 mcg trained COMBINATION_PRODUCT

we are looking at the trained use of Respimat after 14 days treatment

Respimat-Tiotropium 5 mcg trained

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients with FEV1/FVC \<70% predicted.
• Mild (GOLD stage I: FEV1 \>80% pred.) to moderate (GOLD stage II: FEV1 50-80% pred.)
• Aged 30 years onwards - there is no upper age limit as we do not want to exclude elderly patients as COPD is primarily a disease in the elderly population.
• Have on-going symptoms or exercise limitation (determined by CAT score)
• Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 2 months).
• Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

• Subjects who lack the capacity to consent will not be recruited.
• Current or past diagnosis of asthma.
• Patients on concurrent oral bronchodilators (theophylline, PDE4 inhibitors) will not be included.
• Patients on other LAMAs will not be included
• History of any chronic respiratory diseases other than COPD.
• History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study.
• Clinical evidence of heart failure (NYHA class III-IV).
• Unstable respiratory disease in the last four weeks prior to the screening visit (indicated by any change in their maintenance inhaled therapy or who have had a lower respiratory tract infection in the previous four weeks).
• Evidence of a respiratory exacerbation requiring emergency room treatment and/or hospitalisation within four weeks before screening.
• Participants with a known or suspected allergy, sensitivity or intolerance to the study drugs (this will be asked directly at the screening visit) or patients with a history of another drug allergy which, in the opinion of the Unit Physician, contraindicates his/her participation in the study.
• Patients with known or suspected cardiac rhythm disorders
• Patients treated with beta-blockers in the week preceding the screening visit and during the study period.
• Females who are pregnant or lactating or are likely to become pregnant during the trial. (a urine pregnancy test will be performed. Women of childbearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions.
• Patients who have evidence of alcohol or substance abuse.
• Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.

Sponsors & Collaborators

• Imperial College London: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Asthma Lab, Royal Brompton Hospital

London, SW36LY, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Omar Usmani
• Organization: Imperial College London

o.usmani@imperial.ac.uk

02073158051

Study Officials

• Omar Usmani

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each volunteer get all treatment in a same sequence

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 17, 2016
• Study Start: February 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 29, 2025
• Results First Posted: November 12, 2019

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)