Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients

NCT02853123 | Completed Phase 4 Results

• 2 other identifiers: 1237.282015-002974-20
• Study Type: interventional
• Target: 106
• Locations: 4 countries
• Sites: 13

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline and week 6

Secondary Outcomes (7)

• Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured Prior to Exercise

  Baseline and week 6

• Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured at the End of Exercise

  Baseline and week 6

• Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Expiratory Volume

  Baseline and week 6

• Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Vital Capacity

  Baseline and week 6

• 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

Study Arms (2)

Tiotropium + Olodaterol

EXPERIMENTAL

Patients will receive tiotropium 5mcg + olodaterol 5mcg in a fixed dose combination once daily.

Drug: Tiotropium; Drug: Olodaterol

Tiotropium

ACTIVE COMPARATOR

Drug: Tiotropium

Interventions

Tiotropium DRUG

fixed dose combination once daily

Tiotropium + Olodaterol

Olodaterol DRUG

fixed dose combination once daily

Tiotropium + Olodaterol

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice guidelines prior to participation in the trial, including medication washout and restrictions
• Diagnosis of Chronic Obstructive Pulmonary Disease and relatively stable airway obstruction: post bronchodilator 30%\<= Forced Expiratory Volume in 1st second (FEV1)\<80% of predicted normal (European Coal and Steel Community) and a post bronchodilator FEV1/Forced Vital Capacity\<0.70 at visit 1
• Male or female patients \>=40 and =\<75 years of age on day of signing consent.
• Current or ex-smokers with a smoking history \> 10 pack-years. Patients who have never smoked cigarettes must be excluded.
• Baseline Dyspnea Index score\< 8 at visit 0.
• Hyperinflation at rest, defined as Functional Residual Capacity \> 120% predicted at visit 1.
• Borg dyspnea score \>=4 at the end of 3min Constant Speed Shuttle Test at visit 2
• Perform technically acceptable pulmonary function tests (spirometry and body plethysmography) and complete multiple shuttle tests during the study period
• Inhale medication in a competent manner from the Respimat® inhaler and from a metered dose inhaler

You may not qualify if:

• Significant disease other than Chronic Obstructive Pulmonary Disease (COPD); a significant disease which, in the investigator's opinion, may (i) put the patient at risk (ii) influence the study results or (iii) cause concern regarding the patient's ability to participate
• Clinically relevant abnormal baseline haematology, blood chemistry, in the investigator's opinion, or creatinine \>x2 Upper Limit Normal will be excluded regardless of clinical condition
• Current documented diagnosis of asthma
• COPD exacerbation in the 6 weeks prior to screening
• Diagnosis of thyrotoxicosis
• History of myocardial infarction within 6 months of screening
• Life-threatening cardiac arrhythmia (investigator judgment)
• Known active tuberculosis
• Any malignancy unless free of disease for at least 5 years (treated basal cell carcinoma or squamous cell skin cancers are allowed)
• History of cystic fibrosis
• Clinically relevant bronchiectasis (investigator judgment)
• Severe emphysema requiring endobronchial interventions within 6 months prior to screening
• History of significant alcohol or drug abuse (investigator judgment)
• Any contraindications for exercise testing
• Patients who have undergone thoracotomy with pulmonary resection

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (13)

Genk - PRAC Janssens, E.

Genk, 3600, Belgium

Location

Hasselt - PRAC Aumann, J-L

Hasselt, 3500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

McMaster Univ. Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3J1, Canada

Location

IUCPQ (Laval University)

Québec, G1V 4G5, Canada

Location

Klinische Forschung Berlin GbR

Berlin, 10787, Germany

Location

IKF Pneumologie GmbH & Co. KG

Frankfurt am Main, 60596, Germany

Location

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, 6419 PC, Netherlands

Location

Gelre Ziekenhuis Zutphen

Zutphen, 7207 AE, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: September 22, 2016
• Primary Completion: July 24, 2017
• Study Completion: August 14, 2017
• Last Updated: September 27, 2019
• Results First Posted: September 27, 2019

Record last verified: 2019-08

Locations

CA (4); BE (3); NL (3); DE (3)