Track topics on Twitter Track topics that are important to you
The study will measure the improvement in lung function in subjects with asthma after inhaling from two inhalers, Albuterol in a dry powder inhaler and albuterol in an HFA (hydrofluoroalkane), metered dose inhaler.
The study objective is to compare the efficacy and safety of albuterol in a dry powder inhaler (DPI) and albuterol in an HFA metered dose inhaler (MDI) after a cumulative dose of 1440mcg administered as 1+1+2+4+8 inhalations (90mcg per inhalation). Another study objective is to compare the pharmacokinetics (metabolism) of albuterol with the two inhalers. The pharmacokinetics of albuterol will be examined in half (24) of the study subjects. To participate in the study, patients must provide written informed consent, washout any prohibited medications and pass all the screen criteria. Once this is done, there will be two treatment visits. At each visit the subject will inhale with both types of inhalers. At each visit, one inhaler will have active drug (albuterol) and one inhaler will have placebo (dummy). The inhaler with the active drug will be switched at the two visits in a random manner. At each visit the subject will inhale with each inhaler a total of 16 times by a specific schedule. The subject will inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler twice (2), wait 30 minutes, inhale from each inhaler four times (4), wait 30 minutes, and then inhale from each inhaler eight times (8). The total time to complete the inhalations should be about 2 hours. Following that, there will be a series of assessments taken at regular times with vital signs measured up to 6 hours, ECG (electrocardiogram) assessed up to 4 hours, blood taken to measure potassium and glucose up to 4 hours, lung function evaluated with spirometry up to 6 hours, and for those subjects participating in the pharmacokinetic evaluation blood will be drawn up to 12 hours. The two study treatment visits will be 3 to 14 days apart. Following these visits, there will be a study concluding visit 1 to 5 days later.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Albuterol dry powder inhaler, Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler)
Teva Clinical Study Site
Teva Branded Pharmaceutical Products, R&D Inc.
Published on BioPortfolio: 2014-08-27T03:16:22-0400
Healthy male and female volunteers without asthma will be recruited to enroll in a single dose 3-way crossover study of the safety and pharmacokinetics of albuterol when administered using...
This study is examining how well a dry powder inhaler albuterol medication (DPI) works to help adult and adolescent subjects 12 years of age and older with persistent asthma improve lung f...
This is a research study designed to compare the single-dose effectiveness of albuterol-HFA-BAI (breath activated inhaler) and albuterol-HFA-MDI (metered dose inhaler) in asthmatics with p...
The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted f...
This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.
BGF MDI, a budesonide, glycopyrronium, and formoterol fumarate dihydrate triple fixed-dose combination metered dose inhaler formulated using co-suspension delivery technology, is currently in Phase II...
The objective of this work is to show the feasibility of manufacturing from a spray drying process particles containing immunoglobulin G capable of being administered by inhalation via a pressurized m...
In Vitro Tests for Aerosol Deposition. VI: Realistic Testing with Different Mouth-Throat Models and In Vitro-In Vivo Correlations for a Dry Powder Inhaler, Metered Dose Inhaler, and Soft Mist Inhaler.
In vitro-in vivo correlations (IVIVC) for lung deposition may be established by testing inhalers in vitro with realistic mouth-throat (MT) models and inhalation profiles (IP). This study was designed ...
Oral inhalation is the recommended delivery method of medications for the treatment of patients with chronic obstructive pulmonary disease (COPD). However, patients may struggle when using the various...
A racemic mixture with a 1:1 ratio of the r-isomer, levalbuterol, and s-albuterol. It is a short-acting beta2-adrenergic agonist with its main clinical use in ASTHMA.
A combined pharmaceutical preparation of Ipratropium Bromide and Albuterol Sulfate that is used to treat the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
A variety of devices used in conjunction with METERED DOSE INHALERS. Their purpose is to hold the released medication for inhalation and make it easy for the patients to inhale the metered dose of medication into their lungs.
The R-isomer of albuterol.
A drug combination of fluticasone and salmeterol that is used as an inhaler formulation to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
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 ...
Asthma is caused by inflammation of small tubes, called bronchi, which carry air in and out of the lungs. If you have asthma, the bronchi will be inflamed and more sensitive than normal. When you come into contact with something that irritates your...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...