Chronic Obstructive Pulmonary disease (COPD) MedDRA version: 18.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Striverdi Respimat 2.5 microgram
Product Name: SPIRIVA 18 microgram, inhalation powder
Pharmaceutical Form: Inhalation powder
INN or Propose
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: COPD 1) COPD patients with FEV1/FVC 80% pred.) to moderate (GOLD stage II: FEV1 50-80% pred.) 3) 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. 4) Have ongoing symptoms or exercise limitation (determined by CAT score) 5) Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 2 months). 6) Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: COPD 1) We will not recruit subjects who lack the capacity to consent. 2) Current or past diagnosis of asthma. 3) Patients on concurrent LABAs or oral bronchodilators (theophylline, PDE4 inhibitors) will not be included. 4) History of any chronic respiratory diseases other than COPD. 5) History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study. 6) Clinical evidence of heart failure (NYHA class III-IV). 7) 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). 8) Evidence of a respiratory exacerbation requiring emergency room treatment and/or hospitalisation within four weeks before screening. 9) Use of systemic (oral or intravenous) steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 12 months. 10) 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. 11) Patient with a contraindication to taking an inhaled long-acting beta-agonists, listed in the British National Formulary (BNF). 12) Patients treated with beta-blockers in the week preceding the screening visit and during the study period. 13) Females who are pregnant or lactating or are likely to become pregnant during the trial. Women of childbearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions. 14) Patients who have evidence of alcohol or substance abuse. 15) Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit. 16) Contraindication to taking Tiotropium bromide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3 Hours Post dosing; Main Objective: Our principle objective is to investigate the effect of tiotropium (a long-acting inhaled bronchodilator), delivered from different devices, on a panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients with mild-moderate COPD. We will compare equivalent doses of Titropium from Respimat (Tiotropium Respimat 5 micrograms once daily), a small particle soft mist inhaler (SMI) compared to delivering it from Handihaler (18 micrograms once daily), a standard large particle dry powder inhaler (DPI). Respimat is a novel inhaler platform that has small particles and a slow inhalation allowing deeper lung drug delivery. We will be using easily performed non-invasive breathing tests to measure response: • Impulse Oscillometry (IOS) parameters • Multiple Nitrogen Washout parameters (MBNW) • Lung function test (LFT) parameters: We will also assess the safety and tolerability, as determined by vital signs of heart rate and blood pressure. ;Secondary Objective: Our secondary objective is to investigate the effect of Inhaler Training with Handihaler on airway function and symptoms. We will train patients in the optimal use of the Handihaler. Therefore if we train patients with the Handihaler properly can we improve (i) lung function (large and small airway) and (ii) clinical symptoms (determined by CAT score).; Primary end point(s): The primary outcome measure will be impulse Oscillometry (IOS) R5-R20. We will measure what effect changing the inhaler device from a Tiotropium DPI-Handihaler to a Tiotropium SMI-Respimat has on this parameter? The dose of the drug will be equivalent for each device – that is Tio 18mcg HH = Tio 5mcg Resp). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other IOS parameters MBNW, DLCO, FVC, FEV1, PEF, CAT score;Timepoint(s) of evaluation of this end point: 3 hours post dosing | — |
Countries
United Kingdom
Outcome results
None listed