NCT02039050

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

January 15, 2014

Last Update Submit

April 10, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic ObstructiveLong-acting muscarinic antagonistsImpulse oscillometry

Outcome Measures

Primary Outcomes (1)

  • Change in trough R5 from baseline after chronic dosing

    4 to 6 weeks

Secondary Outcomes (7)

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

    4 to 6 weeks

  • Spirometry (FEV1, FEF25-75, FVC)

    4 to 6 weeks

  • Relaxed VC (RVC) with RVC to FVC ratio

    4 to 6 weeks

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

    4 to 6 weeks

  • Domiciliary PIKO-6 measurements for FEV1 and FEV6

    4 to 6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Tiotropium

ACTIVE COMPARATOR

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

Drug: Tiotropium

Aclidinium

EXPERIMENTAL

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

Drug: Aclidinium

Interventions

TiotropiumDRUG
Tiotropium
AclidiniumDRUG
Aclidinium

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma and Allergy Research Group, University of Dundee

Dundee, DD1 9SY, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26758884RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromideaclidinium bromide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Brina Lipworth, MD

    University of Dundee

    PRINCIPAL INVESTIGATOR

  • Arvind Deva Manoharan, MBChB

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Allergy and Pulmonology

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 17, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

GB(1)