The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
PT003 MDI, PT005 MDI, Placebo MDI, Tiotropium bromide 18 μg (Spiriva Handihaler®), Formoterol Fumarate 12 μg (Foradil® Aerolizer®), PT001 MDI
Spartanburg Medical Research
Spartanburg
South Carolina
United States
29303
Recruiting
Pearl Therapeutics, Inc.
Published on BioPortfolio: 2014-08-27T03:15:18-0400
Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler
Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dos...
The overall objective is to asses the bronchodilator effect of once daily Tiotropium/Formoterol combination delivered via Discair® compared to Tiotropium (q.d.) monotherapy delivered via ...
The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/...
The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/...
Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler
This randomised, open-label, cross-over, placebo-containing inhaler study assessed patient preference indicators for ELLIPTA and HandiHaler dry powder inhalers in patients with COPD (NCT02786927; GSK ...
Effect of tiotropium on spontaneous expiratory flow-volume curves during exercise in GOLD 1-2 COPD.
This substudy of a large, randomized, controlled trial (NCT01072396) examined tiotropium (18 μg qd) effects on dynamic hyperinflation during constant work rate treadmill exercise. Areas-under-the-s...
Few studies have assessed the safety and efficacy of potential asthma medications in children younger than 5 years. We descriptively assessed the safety and efficacy of tiotropium, a long-acting antic...
This gamma scintigraphy imaging study was the first to assess pulmonary and extrathoracic deposition and regional lung deposition patterns of a radiolabelled long-acting muscarinic antagonist/long-act...
Bronchodilator therapy is central to the management of chronic obstructive pulmonary disease and are recommended as the preferred treatment by the Global Obstructive Lung Disease Initiative (GOLD). Lo...
Tiotropium Bromide
A scopolamine derivative and CHOLINERGIC ANTAGONIST that functions as a BRONCHODILATOR AGENT. It is used in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
Budesonide, Formoterol Fumarate Drug Combination
A pharmaceutical preparation of budesonide and formoterol fumarate that is used as an ANTI-ASTHMATIC AGENT and for the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
Mometasone Furoate, Formoterol Fumarate Drug Combination
A pharmaceutical preparation of mometasone furoate and formoterol fumarate that is used as an inhaled dosage form for the treatment of ASTHMA.
Cyanogen Bromide
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.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.