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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085161
• Other study ID #: 1237.16
• Secondary ID: 2013-002671-18
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2014
• Last updated: November 3, 2015
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods AdministrationAustria: Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicinal and Health ProductsCanada: Health CanadaDenmark: The Danish Health and Medicines AuthorityGermany: Federal Institute for Drugs and Medical DevicesNew Zealand: MedsafePoland: Registration Medicinal Product Medical Device Biocidal ProductPortugal: National Pharmacy and Medicines InstituteUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

• Patients who have undergone thoracotomy with pulmonary resection.

• Patients being treated with any oral ß-adrenergics.

• Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.

• Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators opinion will be unable to abstain from the use of oxygen therapy during clinic visits.

• Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.

• Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.

• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit.

• Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, benzalkonium chloride, disodium edentat, or any other component of the Respimat® inhalation solution delivery system.

• Pregnant or nursing women.

• Women of childbearing potential not using highly effective methods of birth control.

• Patients who have previously been randomized in this study or are currently participating in another study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• placebo to tiotropium + olodaterol
comparator
• tiotropium
tiotropium 5 mcg once daily
• olodaterol
olodaterol 5 mcg once daily fixed dose combination
• tiotropium
tiotropium 5 mcg once daily fixed dose combination

Locations

Country	Name	City	State
Australia	1237.16.61601 Boehringer Ingelheim Investigational Site	Daw Park	South Australia
Australia	1237.16.61602 Boehringer Ingelheim Investigational Site	Glen Osmond	South Australia
Austria	1237.16.43602 Boehringer Ingelheim Investigational Site	Salzburg
Belgium	1237.16.32603 Boehringer Ingelheim Investigational Site	Genk
Belgium	1237.16.32602 Boehringer Ingelheim Investigational Site	Hasselt
Belgium	1237.16.32601 Boehringer Ingelheim Investigational Site	Leuven
Canada	1237.16.11601 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1237.16.11604 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1237.16.11603 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	1237.16.11602 Boehringer Ingelheim Investigational Site	Ste-Foy	Quebec
Denmark	1237.16.45002 Boehringer Ingelheim Investigational Site	København NV
Denmark	1237.16.45003 Boehringer Ingelheim Investigational Site	Kolding
Denmark	1237.16.45001 Boehringer Ingelheim Investigational Site	Odense
Germany	1237.16.49603 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.16.49605 Boehringer Ingelheim Investigational Site	Bochum
Germany	1237.16.49606 Boehringer Ingelheim Investigational Site	Frankfurt
Germany	1237.16.49604 Boehringer Ingelheim Investigational Site	Großhansdorf
Germany	1237.16.49601 Boehringer Ingelheim Investigational Site	Heidelberg
Germany	1237.16.49608 Boehringer Ingelheim Investigational Site	Leverkusen
Germany	1237.16.49607 Boehringer Ingelheim Investigational Site	Solingen
Germany	1237.16.49602 Boehringer Ingelheim Investigational Site	Teuchern
Germany	1237.16.49609 Boehringer Ingelheim Investigational Site	Tübingen
New Zealand	1237.16.64601 Boehringer Ingelheim Investigational Site	Greenlane East Auckland NZ
Poland	1237.16.48602 Boehringer Ingelheim Investigational Site	Gdansk
Poland	1237.16.48601 Boehringer Ingelheim Investigational Site	Lodz
Poland	1237.16.48604 Boehringer Ingelheim Investigational Site	Starachowice
Portugal	1237.16.35601 Boehringer Ingelheim Investigational Site	Coimbra
Portugal	1237.16.35604 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1237.16.35603 Boehringer Ingelheim Investigational Site	Porto
United Kingdom	1237.16.44602 Boehringer Ingelheim Investigational Site	Leicester
United Kingdom	1237.16.44601 Boehringer Ingelheim Investigational Site	Norwich
United Kingdom	1237.16.44603 Boehringer Ingelheim Investigational Site	Sheffield
United States	1237.16.01603 Boehringer Ingelheim Investigational Site	Hartford	Connecticut
United States	1237.16.01602 Boehringer Ingelheim Investigational Site	San Diego	California
United States	1237.16.01601 Boehringer Ingelheim Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Germany,  New Zealand,  Poland,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance time [sec] during Endurance Shuttle Walk Test to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption after 8 weeks of treatment		8 weeks	No
Secondary	Resting inspiratory capacity measured at 1.5 hours post dose after 8 weeks of treatment		8 weeks	No
Secondary	Average daily walking time measured by the activity monitor in the week prior to 12 weeks of treatment		12 weeks	No
Secondary	Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment		12 weeks	No
Secondary	Functional Performance Inventory-Short Form score at Week 12		12 weeks	No
Secondary	Endurance time [sec] during Endurance Shuttle Walk Test to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption after 12 weeks of treatment		12 weeks	No
Secondary	One hour post-dose forced expiratory volume in one second after 8 weeks of treatment		8 weeks	No
Secondary	One hour post-dose forced vital capacity after 8 weeks of treatment		8 weeks	No