Evaluation of long-acting muscarinic antagonists in COPD

Phase 1

Conditions: Chronic Obstructive Pulmonary Disease
MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-003594-99-GB

Lead Sponsor: Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 14

Inclusion Criteria

•Male and female volunteers aged 40-80 years with moderate to severe COPD (GOLD Stage 2, 3).
•On inhaled corticosteroids / long-acting beta agonists
•FEV1 30-80% predicted and FEV1/FVC <70%.
•Smoking history =10 pack-years.
•Ability to give informed consent
•Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s well being

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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

•Other respiratory diseases such as asthma, bronchiectasis or ABPA
•A COPD exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement (3 months if hospitalisation has been required)
•Any clinically significant medical condition that may endanger the health or safety of the participant
•Known or suspected sensitivity to/intolerance of IMP
•Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma
•Pregnancy or lactation
•Unable to comply with the procedures of the protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the chronic dosing impact of drug-device interaction between tiotropium and aclidinium on early morning trough bronchodilator response using impulse oscillometry in patients with COPD taking inhaled corticosteroids/long-acting beta agonists combination therapy. ;Secondary Objective: Not applicable;Primary end point(s): Change in trough R5 from baseline after chronic dosing;Timepoint(s) of evaluation of this end point: 2 to 3 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Remaining IOS variables (R20,R5-R20,X5,AX,RF)<br>Spirometry (FEV1, FEF25-75, FVC)<br>Relaxed VC (RVC) with RVC to FVC ratio<br>Six-minute walk test (includes oxygen saturation measurements and<br>Borg dyspnoea score)<br>Domiciliary PIKO-6 measurements for FEV1 and FEV6<br>SGRQ<br>BDI-TDI;Timepoint(s) of evaluation of this end point: 2 to 3 weeks