Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium
Drug: Olodaterol

Registration Number: NCT02853123

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The primary objective of the present study is to evaluate the effect of tiotropium + olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity of breathlessness during the 3min constant speed shuttle test (CSST).

A secondary objective is to explore the relationship between reductions in breathlessness during the 3min CSST and reductions in breathlessness during activities of everyday living as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following bronchodilator therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tiotropium + Olodaterol	Tiotropium	Patients will receive tiotropium 5mcg + olodaterol 5mcg in a fixed dose combination once daily.
Tiotropium + Olodaterol	Olodaterol	Patients will receive tiotropium 5mcg + olodaterol 5mcg in a fixed dose combination once daily.
Tiotropium	Tiotropium	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intensity of Breathlessness Measured Using the Modified Borg Scale at the End of the 3 Minute (Min) Constant Speed Shuttle Test After 6 Weeks of Treatment.	Baseline and week 6	At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Expiratory Volume	Baseline and week 6	Forced Expiratory Volume in 1st second (FEV1) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FEV1, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline.
Change From Baseline After 6 Weeks of Treatment for Intensity of Breathlessness (MBS-S) at 1, 2 and 2.5 Minute (Min) During the 3 Min Constant Speed Shuttle Test	Baseline and week 6	At 1, 2 and 2.5 min during exercise, patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline.
Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) Dyspnoea Domain Score	Baseline and week 6	CRQ-SAS was questionnaire to assess patients' perception of COPD and measures the impact of COPD on their life. This version was derived from the original CRQ tool \& therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function \& mastery. The CRQ-SAS refers to the CRQ-Self-administered standardized format \& contains 20 questions. The first part of the questionnaire contains 5 standardized dyspnea questions and the patients must indicate how much shortness of breath they have experienced while performing each of these 5 activities. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline.
Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured Prior to Exercise	Baseline and week 6	Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed prior to the 3min Constant Speed Shuttle Test (CSST) (at rest). Measure type is actually Adjusted Mean Change from Baseline.
Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured at the End of Exercise	Baseline and week 6	Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed at the end of the 3min Constant Speed Shuttle Test (CSST). Measure type is actually Adjusted Mean Change from Baseline.
Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Vital Capacity	Baseline and week 6	Forced Vital Capacity (FVC) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FVC, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline.
Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Individualized (CRQ-SAI) Dyspnoea Domain Score	Baseline and week 6	CRQ-SAI refers to the CRQ-Self-administered individualized format as it contains a dyspnea domain that is individualized to each patient. This version was derived from the original CRQ tool \& therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function \& mastery. Dyspnea items may be selected from list of 26 suggested items or written in by the patients. The patients are asked to select up to 5 activities associated with breathlessness that they perform frequently and are most important to them. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline.

Trial Locations

Locations (13): Hasselt - PRAC Aumann, J-L
🇧🇪
Hasselt, Belgium
McGill University Health Centre (MUHC)
🇨🇦
Montreal, Quebec, Canada
McMaster Univ. Medical Centre
🇨🇦
Hamilton, Ontario, Canada
UZ Leuven
🇧🇪
Leuven, Belgium
Kingston General Hospital
🇨🇦
Kingston, Ontario, Canada
Klinische Forschung Berlin GbR
🇩🇪
Berlin, Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
🇩🇪
Großhansdorf, Germany
Catharina Ziekenhuis
🇳🇱
Eindhoven, Netherlands
IKF Pneumologie GmbH & Co. KG
🇩🇪
Frankfurt am Main, Germany
Gelre Ziekenhuis Zutphen
🇳🇱
Zutphen, Netherlands
Zuyderland Medisch Centrum
🇳🇱
Heerlen, Netherlands
Genk - PRAC Janssens, E.
🇧🇪
Genk, Belgium
IUCPQ (Laval University)
🇨🇦
Quebec, Canada