NCT02567214

Brief Summary

The investigators will compare the reduction in Borg dyspnea score during the 3-min constant rate shuttle walking test after 3 weeks of indacaterol 110 µg/Glycopyrronium 50 µg (Ultibro®) versus Tiotropium 18 µg (Spiriva®) alone in patients with moderate to severe COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2016

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

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

September 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

2.5 years

First QC Date

September 25, 2015

Last Update Submit

June 6, 2019

Conditions

COPD

Keywords

dyspneaexerciseshuttle testlong-acting β2-agonistslongacting muscarinic antagonistindacaterolglycopyrroniumtiotropium

Outcome Measures

Primary Outcomes (1)

  • Reduction of dyspnea score during the 3-min constant rate shuttle walk test

    To compare the reduction in dyspnea in each arm of the study using the BORG scale and the questionnaire BDI-TDI.

    21 days

Secondary Outcomes (3)

  • Improvement of the pulmonary function after taking Ultibro® and Spiriva®

    21 days

  • Impact of Ultibro® and Spiriva® on exertional dyspnea after the first dose of therapy

    1 day

  • Impact of Ultibro® and Spiriva® on quality of life measured with the CAT questionnaire.

    21 days

Study Arms (2)

Ultibro® versus sham Spiriva®

EXPERIMENTAL

Indacaterol 110 µg/Glycopyrronium 50 µg Inhaled 1 time per day 21 days

Drug: Ultibro®

Sham Ultibro® versus Spiriva®

EXPERIMENTAL

Tiotropium 18 µg Inhaled 1 time per day 21 days

Drug: Spiriva®

Interventions

Ultibro®DRUG

The intervention in this arm is the Ultibro®. To keep the patients blinded on which treatement they are taking they will use the two devices but in this arm the Ultibro will be delivered and the Spiriva will be a placebo. We will measure the exertional dyspnea after 21 days of treatment.

Also known as: Indacaterol 110 µg/Glycopyrronium 50 µg
Ultibro® versus sham Spiriva®
Spiriva®DRUG

The intervention in this arm is the Spiriva®. To keep the patients blinded on which treatement they are taking they will use the two devices but in this arm the Ultibro will be a placebo and the Spiriva will be delivered. We will measure the exertional dyspnea after 21 days of treatment.

Also known as: Tiotropium 18 µg
Sham Ultibro® versus Spiriva®

Eligibility Criteria

Age51 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 50 years
  • Smoking history \> 10 packs/year
  • FEV1 30 - 79% of predicted and FEV1/FVC \< 70% (GOLD 2-3)
  • FRC \> 120 % predicted
  • Borg dyspnea score \> 3 during the 3-min constant rate shuttle walking test at V3

You may not qualify if:

  • Respiratory exacerbation within the 2 months preceding the study
  • Current diagnostic of asthma
  • Significant O2 desaturation (SpO2 \< 85%) at rest or during exercise
  • Presence of another pathology that could influence exercise tolerance
  • Use of home oxygen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Queens University

Kingston, Ontario, K7L 2V6, Canada

Location

McGill University

Montreal, Quebec, H2W 1S4, Canada

Location

Laval University - IUCPQ

Québec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspneaMotor Activity

Interventions

indacaterolGlycopyrrolateTiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • François Maltais, MD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 25, 2015

First Posted

October 2, 2015

Study Start

June 1, 2016

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

June 7, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)