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Pulmonary
Current Clinical Trials in  Asthma, Chronic Obstructive Pulmonary Disease(COPD),  Cystic Fibrosis, Pulmonary Arterial Hypertension (PAH) and Idiopathic Pulmonary Fibrosis


A Comparison of SYMBICORT pMDI With Budesonide HFA pMDI in African American Subjects With Asthma. PDF Print E-mail
  • The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.
 
A Study of Xolair in Subjects With Moderate to Severe Persistent Asthma (EXTRA) PDF Print E-mail
  • This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy to high-dose ICS+LABA for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose ICS+LABA.
 
An Observational Prospective Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants (32 to 35 Week Gestational Age) - Outcomes and Risk Tracking Study (The Report Study) PDF Print E-mail

This is an observational, prospective study of preterm infants 32 to 35 wGA. Subjects will be screened and entered into the study during their earliest pediatric outpatient visit (routine well-baby visit or unscheduled sick visit), from 01Sep2009 through 31Jan2010 for Season 1, and from 01Sep2010 through 31Jan2011 for Season 2. All subjects will be followed up to the end of their first RSV season (31May). Interval (between-visit) RSV infections, hospitalizations, ED visits, and outpatient LRIs will be assessed during each follow-up visit between the Initial Visit and 31May. When an interval event is reported, medical records/charts will be obtained by the investigator to collect all study-pertinent information, including any RSV testing and results.
 
A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD PDF Print E-mail
  • The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
 
Chronic Obstructive Pulmanary Disease (COPD) Post-hospitalization Study PDF Print E-mail
This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted in the United States. The purpose of the study is to evaluate the rate of exacerbations of chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute exacerbation of COPD, in patients receiving either fluticasone propionate/salmeterol combination product 250/50mcg BID or salmeterol 50mcg BID via DISKUS™ over 29 weeks. The study population will include patients hospitalized for an acute exacerbation of COPD
 
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (INTRUST2) PDF Print E-mail
  • This study will assess efficacy and safety of indacaterol (150 µg once daily [o.d.]) when combined with tiotropium (18 µg o.d.) versus tiotropium (18 µg o.d.) treatment alone in patients with chronic obstructive pulmonary disease (COPD)
 
Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients PDF Print E-mail
  • To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.

 
 
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules PDF Print E-mail
  • The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI).
 
Aztreonam for Inhalation Solution (AZLI) vs Tobramycin Inhalation Solution (TOBI®) in Patients With CF & P. Aeruginosa PDF Print E-mail

The purpose of this study is to assess the comparative safety and effectiveness of Aztreonam for Inhalation Solution versus Tobramycin Nebuliser Solution in adult and pediatric patients with CF and pulmonary Pseudomonas aeruginosa (PA) infection.
 
Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation PDF Print E-mail
  • A major factor in the respiratory health of CF subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation (ArikaceTM) is a sustained-release formulation of amikacin encapsulated inside nanoscale liposomal carriers designed for administration via inhalation. It is hypothesized that the sustained-release pulmonary targeting and biofilm penetration properties of this formulation will have several advantages over current therapies in treating CF subjects with chronic infection caused by P. aeruginosa.

 
 
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