Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol on Muscular Efficiency and Resting Energy Expenditure (REE) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)

NCT02172794 | Completed Phase 3

• 1 other identifier: 205.261
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate the effect of tiotropium on gross muscular efficiency

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Bruto muscular efficiency by one-point measurement of energy expenditure (EE) during bicycling at 50% Wmax

  Day 42, 84, 126

Secondary Outcomes (11)

• Resting energy expenditure (REE)

  Day 42, 84, 126

• Endurance capacity in minutes

  Day 42, 84, 126

• Nett muscular efficiency (%)

  Day 42, 84, 126

• Forced expiratory volume in one second (FEV1)

  Up to day 140

• Peak expiratory flow (PEF) variability

  Up to day 140

Study Arms (2)

tiotropium

EXPERIMENTAL

Drug: Tiotropium; Drug: Placebo to tiotropium

salmeterol

ACTIVE COMPARATOR

Drug: Salmeterol; Drug: Placebo to salmeterol

Interventions

Tiotropium DRUG

tiotropium

Placebo to tiotropium DRUG

tiotropium

Salmeterol DRUG

salmeterol

Placebo to salmeterol DRUG

salmeterol

Eligibility Criteria

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

You may qualify if:

• All patients had to sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
• Male or female patients 40 years of age or older.
• All patients had to have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
• Patients had to have moderate to severe airway obstruction with a postbronchodilator FEV1/FVC ≤ 70% and FEV1 ≤ 60% predicted (Visit 1).
• FEV1 % predicted and/or forced vital capacity (FVC) increases \>5% after inhalation with 480 μg salbutamol and 80 μg ipratropium
• Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years.
• Patients had to be able to perform technically acceptable pulmonary function tests and had to be able to maintain records (Patient Daily Record) during the study period as required in the protocol.
• Patients had to be able to inhale medication from the HandiHaler, and from an inhalation aerosol.
• Patients should have had a ventilatory limitation of maximal exercise capacity:
• Increase in arterial carvon dioxide tension (PaCO2) during incremental bicycle test and/or increase in minute ventilation (VE) max \> 80% (FEV1 x 37.5)
• Patients should have had a Wmax ≥ 40 Watt during maximal incremental bicycle test.

You may not qualify if:

• Increase of blood lactate \> 10 mmol/L at peak exercise
• Increase of blood lactate \>2.5 mmol/L at ≥ 50% of Wmax
• Decrease of oxygen saturation below 90% at ≥ 50% of Wmax
• Patients with significant diseases other than COPD had to be excluded. A significant disease was defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
• Patients with clinically relevant abnormal haemoglobulin, leukocytes, thrombocytes, glucose, sodium, potassium.
• Patients with a recent history (i.e., six months or less) of myocardial infarction.
• Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
• Patients with known active tuberculosis.
• Patients on oxygen therapy.
• Patients with a history of cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
• Patients with any respiratory infection in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period. The enrolment of these patients was to be postponed for at least six weeks.
• Patients who have frequent exacerbations (at least three in the preceding year) which could be expected to interfere with the patient's ability to participate in the trial should be excluded.
• Patients with known hypersensitivity to anticholinergic drugs, beta adrenergics, lactose or any other components of the inhalation capsule delivery system.
• Patients with a history of cancer within the last three years. Patients with treated basal cell carcinoma were allowed. Patients with successfully treated cancers greater than five years prior to entry were allowed.
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Salmeterol Xinafoate

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; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: May 1, 2002
• Primary Completion: October 1, 2005
• Last Updated: August 31, 2018

Record last verified: 2018-08