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Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in COPD Patients

2015-07-02 07:53:22 | BioPortfolio

Summary

The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

QVA149, Umeclidinium/vilanterol, Placebo (umeclidinium/vilanterol ), Placebo (QVA149)

Location

Novartis Investigative Site
Little Rock
Arkansas
United States
72205

Status

Not yet recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-07-02T07:53:22-0400

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Efficacy and Safety Study of QVA149 in COPD Patients

The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-speci...

The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Symp

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Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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QVA Mechanistic Efficacy Study (Receptor Effects, Etc)

The purpose of this study is to assess global ventilated lung volume in moderate to severe COPD patients using MRI lung imaging after 8 days of treatment with QVA149 compared to placebo.

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The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chron...

PubMed Articles [807 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics of Single and Repeat Doses of Fluticasone Furoate/Umeclidinium/Vilanterol in Healthy Chinese Adults.

The pharmacokinetics (PK) and safety of single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) after single and repeat dosing in healthy Chinese adults were assessed. In this open-lab...

Efficacy and safety of the dual bronchodilator combination umeclidinium/vilanterol in COPD by age and airflow limitation severity: A pooled post hoc analysis of seven clinical trials.

Elderly patients with chronic obstructive pulmonary disease (COPD) and those with more severe airway limitation are perceived to experience reduced efficacy from inhaled bronchodilators, especially th...

Rewarded placebo analgesia: A new mechanism of placebo effects based on operant conditioning.

Placebo analgesia is explained by two learning processes: classical conditioning and observational learning. A third learning process, operant conditioning, has not previously been investigated as a m...

A short essay on the spirituality of placebo from an (evolutionary) psychiatric perspective.

Different to spirituality, the placebo-effect is well operationalized. Against this background, an attempt is made to look at a possible phenomenological relationship between the therapeutic effective...

Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research.

Placebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, parti...

Medical and Biotech [MESH] Definitions

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.

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