NCT02085161|CompletedPhase 3Results

To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways

An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim ClinicalTrials.gov

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2 other identifiers

1237.162013-002671-18

Study Type

interventional

Target

304

Locations

10 countries

Sites

Timeline

RegisteredMar 2014

StartedMar 2014

CompletionOct 2015

Brief Summary

The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD

Trial Health

On Track

Trial Health Score

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

Enrollment

304

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Mar 2014

Geographic Reach

10 countries

32 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

1.6 years study duration

Study Start

First participant enrolled

March 1, 2014

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

January 6, 2017

Completed

Last Updated

January 6, 2017

Status Verified

November 1, 2016

Enrollment Period

1.4 years

First QC Date

March 7, 2014

Results QC Date

August 30, 2016

Last Update Submit

November 9, 2016

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.
Week 8

Secondary Outcomes (7)

Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12
Week 12
Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment
Week 12
Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12
Week 12
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks
Week 12
One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment
Week 8
+2 more secondary outcomes

Study Arms (4)

placebo

PLACEBO COMPARATOR

patient will receive placebo once daily, 2 puffs in the morning

Drug: placebo to tiotropium + olodaterol

tiotropium + olodaterol high dose with BM

EXPERIMENTAL

patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning

Drug: tiotropium +olodaterol

tiotropium

ACTIVE COMPARATOR

patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning

Drug: tiotropium

tiotropium + olodaterol with exercise training and BM

EXPERIMENTAL

patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning

Drug: tiotropium+olodaterol

Interventions

placebo to tiotropium + olodaterolDRUG

comparator

placebo

tiotropium+olodaterolDRUG

tiotropium 5 mcg once daily

tiotropium + olodaterol with exercise training and BM

tiotropium +olodaterolDRUG

olodaterol 5 mcg once daily fixed dose combination

tiotropium + olodaterol high dose with BM

tiotropiumDRUG

tiotropium 5 mcg once daily fixed dose combination

tiotropium

Eligibility Criteria

Age40 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All patients must sign an informed consent consistent with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator forced expiratory volume in one second \>=30% and \<80% of predicted normal; Global Initiative for Chronic Obstructive Lung Disease grade II - III, and a post-bronchodilator Tiffeneau index \<70% at Visit 1.
Male or female patients, aged \>=40 years and \<=75 years.
Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.

You may not qualify if:

Patients with a significant disease other than chronic obstructive pulmonary disease.
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis.
Patients with a history of asthma.
A diagnosis of thyrotoxicosis.
A diagnosis of paroxysmal tachycardia (\>100 beats per minute).
A history of myocardial infarction within 1 year of screening visit.
Unstable or life-threatening cardiac arrhythmia.
Hospitalized for heart failure within the past year.
Known active tuberculosis.
A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years.
A history of life-threatening pulmonary obstruction and patients with chronic respiratory failure.
A history of cystic fibrosis.
Clinically evident bronchiectasis.
A history of significant alcohol or drug abuse.
Any contraindications for exercise testing.
+11 more criteria

Contact the study team to confirm eligibility.