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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: tiotropium; Drug: tiotropium+olodaterol; Drug: placebo to tiotropium + olodaterol; Drug: tiotropium +olodaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02085161

2013-002671-18 (EudraCT Number)

1237.16

Details and patient eligibility

About

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

Enrollment: 304 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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304 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo to tiotropium + olodaterol

tiotropium + olodaterol high dose with BM

Experimental group

Description:

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

Treatment:

Drug: tiotropium +olodaterol

tiotropium

Active Comparator group

Description:

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

Treatment:

Drug: tiotropium

tiotropium + olodaterol with exercise training and BM

Experimental group

Description:

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

Treatment:

Drug: tiotropium+olodaterol