Evaluation of long-acting muscarinic antagonists in COPD

Proof of Concept Evaluation of Drug-Device Interaction with aclidinium bromide via Genuair® and tiotropium bromide via HandiHaler® in COPD using Impulse Oscillometry - MAN04 Evaluation of Long-Acting Muscarinic Antagonists in COPD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003594-99-GB

Enrollment

Registered

2013-12-03

Start date

2013-11-27

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855

Interventions

Trade Name: Eklira Genuair Product Name: Eklira Genuair Pharmaceutical Form: Inhalation powder INN or Proposed INN: aclidinium bromide CAS Number: 320345-99-1 Concentration unit: µg microgram(s) Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

United Kingdom

Contacts

Public ContactArvind Manoharan

University of Dundee

a.d.manoharan@dundee.ac.uk01382 383235

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026