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

NCT ID: NCT02085161

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-10-31

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo to tiotropium + olodaterol

Intervention Type: DRUG

comparator

tiotropium + olodaterol high dose with BM

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

Group Type: EXPERIMENTAL

tiotropium +olodaterol

Intervention Type: DRUG

olodaterol 5 mcg once daily fixed dose combination

tiotropium

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

Group Type: ACTIVE_COMPARATOR

tiotropium

Intervention Type: DRUG

tiotropium 5 mcg once daily fixed dose combination

tiotropium + olodaterol with exercise training and BM

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

Group Type: EXPERIMENTAL

tiotropium+olodaterol

Intervention Type: DRUG

tiotropium 5 mcg once daily

Interventions

placebo to tiotropium + olodaterol

comparator

Intervention Type: DRUG

tiotropium+olodaterol

tiotropium 5 mcg once daily

Intervention Type: DRUG

tiotropium +olodaterol

olodaterol 5 mcg once daily fixed dose combination

Intervention Type: DRUG

tiotropium

tiotropium 5 mcg once daily fixed dose combination

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Boehringer Ingelheim Investigational Site

San Diego, California, United States

Boehringer Ingelheim Investigational Site

Torrance, California, United States

Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Boehringer Ingelheim Investigational Site

Daw Park, South Australia, Australia

Boehringer Ingelheim Investigational Site

Glen Osmond, South Australia, Australia

Boehringer Ingelheim Investigational Site

Salzburg, , Austria

Boehringer Ingelheim Investigational Site

Genk, , Belgium

Boehringer Ingelheim Investigational Site

Hasselt, , Belgium

Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Boehringer Ingelheim Investigational Site

Kolding, , Denmark

Boehringer Ingelheim Investigational Site

København NV, , Denmark

Boehringer Ingelheim Investigational Site

Odense, , Denmark

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Boehringer Ingelheim Investigational Site

Bochum, , Germany

Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

Boehringer Ingelheim Investigational Site

Heidelberg, , Germany

Boehringer Ingelheim Investigational Site

Leverkusen, , Germany

Boehringer Ingelheim Investigational Site

Solingen, , Germany

Boehringer Ingelheim Investigational Site

Teuchern, , Germany

Boehringer Ingelheim Investigational Site

Tübingen, , Germany

Boehringer Ingelheim Investigational Site

Greenlane East Auckland NZ, , New Zealand

Boehringer Ingelheim Investigational Site

Gdansk, , Poland

Boehringer Ingelheim Investigational Site

Lodz, , Poland

Boehringer Ingelheim Investigational Site

Starachowice, , Poland

Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Boehringer Ingelheim Investigational Site

Porto, , Portugal

Boehringer Ingelheim Investigational Site

Leicester, , United Kingdom

Boehringer Ingelheim Investigational Site

Norwich, , United Kingdom

Boehringer Ingelheim Investigational Site

Sheffield, , United Kingdom

Countries

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

References

Troosters T, Bourbeau J, Maltais F, Leidy N, Erzen D, De Sousa D, Korducki L, Hamilton A. Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design. BMJ Open. 2016 Apr 13;6(4):e010106. doi: 10.1136/bmjopen-2015-010106.

Reference Type: DERIVED

PMID: 27075841 (View on PubMed)

Bourbeau J, Lavoie KL, Sedeno M, De Sousa D, Erzen D, Hamilton A, Maltais F, Troosters T, Leidy N. Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation. BMJ Open. 2016 Apr 4;6(4):e010109. doi: 10.1136/bmjopen-2015-010109.

Reference Type: DERIVED

PMID: 27044576 (View on PubMed)

Other Identifiers

2013-002671-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.16

Identifier Type: -

Identifier Source: org_study_id