Advertisement

Topics

26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

2014-08-27 03:38:57 | BioPortfolio

Summary

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention

Indacaterol 75µg o.d, indacaterol 150 µg o.d., indacaterol 300 µg o.d., indacaterol 600 µg o.d., Formoterol (12 µg b.i.d), Tiotropium (18 µg o.d.), placebo

Location

Pinnacle Research Group, LLC
Anniston
Alabama
United States
36207

Status

Completed

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:57-0400

Clinical Trials [1495 Associated Clinical Trials listed on BioPortfolio]

Efficacy, Safety and Tolerability of Once-daily (o.d.) Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily (b.i.d.) as Active Control

This study is designed to assess the efficacy and long-term safety data for the 300 and 600 µg doses of indacaterol when delivered via a single dose dry powder inhaler (SDDPI) in patients...

Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment...

Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma

This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.

Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day...

Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study is designed to provide pivotal confirmation of efficacy and safety data of two doses of indacaterol (150 and 300 µg once daily; o.d.) in patients with moderate to severe COPD. ...

PubMed Articles [3365 Associated PubMed Articles listed on BioPortfolio]

Development and validation of an UHPLC-MS/MS method for β2-agonists quantification in human urine and application to clinical samples.

A fast analytical method for the simultaneous detection of 24 β2-agonists in human urine was developed and validated. The method covers the therapeutic drugs most commonly administered, but also pote...

Efficacy of budesonide/formoterol and tiotropium combination for the treatment of Chinese patients with chronic obstructive pulmonary disease.

This study investigated the efficacy and safety of budesonide/formoterol (B/F) and tiotropium combination in the management of chronic obstructive pulmonary disease (COPD) in Chinese patients.Between ...

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...

Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial.

Combinations of long-acting bronchodilators are recommended to reduce the rate of chronic obstructive pulmonary disease (COPD) exacerbations. It is unclear whether combining olodaterol, a long-acting ...

Safety and pharmacokinetics of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) in healthy adult subjects of Japanese descent.

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...

Medical and Biotech [MESH] Definitions

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.

A scopolamine derivative and CHOLINERGIC ANTAGONIST that functions as a BRONCHODILATOR AGENT. It is used in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

A pharmaceutical preparation of mometasone furoate and formoterol fumarate that is used as an inhaled dosage form for the treatment of ASTHMA.

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

More From BioPortfolio on "26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

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...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Pulmonary
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 ...


Searches Linking to this Trial