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Evaluation of Long-Acting Muscarinic Antagonists in COPD (MAN04)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Tiotropium

Aclidinium

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Long-acting muscarinic antagonists, Impulse oscillometry

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being

Exclusion Criteria:

Other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis
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 investigational medicinal product
Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma
Pregnancy or lactation
Unable to comply with the procedures of the protocol

Sites / Locations

Asthma and Allergy Research Group, University of Dundee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tiotropium

Aclidinium

Arm Description

Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.

Outcomes

Primary Outcome Measures

Change in trough R5 from baseline after chronic dosing

Secondary Outcome Measures

Remaining impulse oscillometry (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

St. George's Respiratory Questionnaire (SGRQ)

Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI)

Full Information

NCT ID

NCT02039050

First Posted

January 15, 2014

Last Updated

April 10, 2019

Sponsor

University of Dundee

Collaborators

Almirall Limited

1. Study Identification

Unique Protocol Identification Number

NCT02039050

Brief Title

Evaluation of Long-Acting Muscarinic Antagonists in COPD

Acronym

MAN04

Official Title

Proof of Concept Evaluation of Drug-Device Interaction With Aclidinium Bromide Via Genuair® and Tiotropium Bromide Via HandiHaler® in COPD Using Impulse Oscillometry

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Dundee

Collaborators

Almirall Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a new LAMA called aclidinium has been approved for use in COPD. There are potentially important differences between these two medications that might have an impact on the treatment of COPD patients. In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD. The main comparison will be done using a very sensitive breathing test called impulse oscillometry

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive, Long-acting muscarinic antagonists, Impulse oscillometry

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tiotropium

Arm Type

Active Comparator

Arm Description

Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.

Arm Title

Aclidinium

Arm Type

Experimental

Arm Description

Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Type

Drug

Intervention Name(s)

Aclidinium

Primary Outcome Measure Information:

Title

Change in trough R5 from baseline after chronic dosing

Time Frame

4 to 6 weeks

Secondary Outcome Measure Information:

Title

Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF)

Time Frame

4 to 6 weeks

Title

Spirometry (FEV1, FEF25-75, FVC)

Time Frame

4 to 6 weeks

Title

Relaxed VC (RVC) with RVC to FVC ratio

Time Frame

4 to 6 weeks

Title

Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score)

Time Frame

4 to 6 weeks

Title

Domiciliary PIKO-6 measurements for FEV1 and FEV6

Time Frame

4 to 6 weeks

Title

St. George's Respiratory Questionnaire (SGRQ)

Time Frame

4 to 6 weeks

Title

Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI)

Time Frame

4 to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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 <70%. Smoking history ≥10 pack-years. Ability to give informed consent Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being Exclusion Criteria: Other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis 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 investigational medicinal product Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma Pregnancy or lactation Unable to comply with the procedures of the protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brina Lipworth, MD

Organizational Affiliation

University of Dundee

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arvind Deva Manoharan, MBChB

Organizational Affiliation

University of Dundee

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asthma and Allergy Research Group, University of Dundee

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26758884

Citation

Manoharan A, Morrison AE, Lipworth BJ. Effects of Adding Tiotropium or Aclidinium as Triple Therapy Using Impulse Oscillometry in COPD. Lung. 2016 Apr;194(2):259-66. doi: 10.1007/s00408-015-9839-y. Epub 2016 Jan 13.

Results Reference

result

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Evaluation of Long-Acting Muscarinic Antagonists in COPD

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