Track topics on Twitter Track topics that are important to you
The purpose of this study is to determine the effect of treatment with tiotropium bromide on efficiency of gas exchange and exercise performance in COPD subjects during exercise.
This study will investigate the effect of tiotropium on gas exchange during exercise. In addition, we hypothesize that bronchodilation by tiotropium will open functional lung units improving gas exchange in subjects with COPD. While other studies have shown that tiotropium improves exertional dyspnea and exercise tolerance, and reduces resistive and elastic work in subjects with COPD, there have been no investigations of the effects of anti-cholinergic bronchodilation on gas exchange. This study will confirm and extend earlier observations on exertional dyspnea and exercise tolerance.
Efficiency of gas exchange will be evaluated through assessments of metabolic demand (VO2) cardiac output (Q), ventilation (V) in overall terms i.e. Q/VO2, V/VO2.
Improved efficiency of gas exchange will reduce the ventilatory demand for a given workload, providing an alternate mechanism for the observed improvement in exertional dyspnea and exercise tolerance in subjects with COPD. The overall ventilation required to meet metabolic demands is dependent on the alveolar volume which can be easily measured using inert gases. This is conveniently measured during the DLco maneuver which will be measured. In general, ventilation increases with metabolic demand but increases progressively as the VA and KCO decline in patients with COPD. These factors may be amenable to improvement using anticholinergic agents. In addition the recruitment of additional alveolar volume provides an additional pathway for blood flow through the lung increasing overall cardiac output and enhancing the responsiveness of peripheral muscle in these patients. These have not been considered and exploited as potential therapeutic goals.
Treatment Period: Visits 2, 3, 5 and 6
- Vital signs (seated)
- 12 lead ECG
- Medication washout compliance.
- Stage one exercise test (refer to section 11.1.7)
- Randomization will occur at Visit 2.
- At visit two the subject will be trained in the use of a HandiHaler
- Study medication will be dispensed at Visit 2 and 5
- Administer study medication (Visits 2,3,4,5 and 6)
Treatment Period: Visits 4 and 7
- Vital signs (seated)
- Administer study medication
- Constant load exercise test (refer to section 11.1.8)
- Collect study medication
- Medication accountability
- Adverse event (A follow up visit must be scheduled if there are any ongoing AEs at visit 7)
Follow up Visit (within 30 days of visit 7):
This visit will take place only if clinically significant abnormalities are seen after all results from Visit 7 are obtained and reviewed by the Investigator and Medical Monitor.
After informed consent, patients will attend an initial screening visit (Visit 1) for review of medical history, clinical assessment, complete pulmonary function testing (plethysmography and spirometry). A symptom-limited incremental cycle exercise test, with measurement of incremental and peak VO2, carbon dioxide output (VCO2), minute ventilation (Ve), Vt, respiratory frequency, heart rate (HR), oxyhemoglobin saturation by pulse oximeter (SpO2) and modified Borg score for breathlessness will also be performed at screening, as well as measurements of airway responses to salbutamol.
Patients who meet the eligibility requirements will be randomized to treatment with tiotropium or placebo. Double-blind medication will be dispensed in HandiHalers to be taken once daily in the morning for 22 days. Patients will report to the laboratory for two separate treatment periods with a washout of 4-6 weeks between treatment periods. A patient diary card will be kept to document morning doses of study medication for calculation of compliance. The patient will return used medication capsules for confirmation of medication compliance. Safety will be assessed by examining adverse events (AEs), resting and exercise electro cardio grams (ECG's), routine laboratory tests and vital signs.
In the event of treatment of an exacerbation with oral corticosteroids, any scheduled visit will be delayed for 1 week following the last dose of steroid treatment.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
tiotropium bromide, Placebo
Published on BioPortfolio: 2014-08-27T03:41:06-0400
This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients wit...
The purpose of the study is to determine the efficacy and safety of the combination of two drugs (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT 250/50mcg plus TIOTROPIUM 18mcg) com...
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 mic tiotropium bromide solution for inhalation, delivered by the Respimat inhaler...
This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory effects...
The purpose of this study is to assess the control of COPD using a symptom and exacerbation risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese subjects w...
Tiotropium bromide has been widely used in clinical practice, while theophylline is another treatment option for chronic obstructive pulmonary disease (COPD). However, only a few relevant studies have...
The efficacy and safety of tiotropium Respimat , a long-acting muscarinic antagonist (LAMA), as add-on to maintenance inhaled corticosteroids (ICS), with or without additional controllers, has been de...
Symptoms of chronic obstructive pulmonary disease (COPD) may diminish patients' health-related quality of life (HRQoL). We report effects of Longhala™ Magnair™ (glycopyrrolate) Inhalation Solution...
Endoscopic inspection of colonic mucosa is disturbed by colonic folds and peristalsis, which may result in missed polyps. Cimetropium bromide, an antispasmodic agent, inhibits peristalsis and colonic ...
The long-acting muscarinic antagonist tiotropium received an indication for the treatment of asthma from the FDA in 2015.
A scopolamine derivative and CHOLINERGIC ANTAGONIST that functions as a BRONCHODILATOR AGENT. It is used in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
Cyanogen bromide (CNBr). A compound used in molecular biology to digest some proteins and as a coupling reagent for phosphoroamidate or pyrophosphate internucleotide bonds in DNA duplexes.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.
COPD (chronic obstructive pulmonary disease)
COPD (chronic obstructive pulmonary disease) is used for a number of conditions including chronic bronchitis and emphysema, which all lead to the airways in the lungs becoming damaged and thus narrower, making inhalation and exhalation harder...
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza, Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...