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Oxis™ (formoterol) Clinical Trial report summaries

Oxis™ (formoterol) is a beta 2-agonist that has a fast-acting, long-lasting bronchodilatory effect. Oxis is delivered using the gold-standard inhaler Turbuhaler.

Oxis, in combination with inhaled steroids, is used for the maintenance treatment of asthma in adults and children aged 6 years and above. It is approved in most of the EU for 'as needed' therapy as part of the maintenance therapy of asthma. 
 
Please consult the prescribing information for the country concerned for guidance on the approved use of Oxis™ (formoterol).

Study NumberCompleted Clinical Trial Report Summaries

D5125C00344

A 3-month, multi-centre, double-blind, double-dummy, randomised, parallel group, phase III study to investigate the efficacy and safety of formoterol HFA pMDI compared with placebo and Oxis Turbuhaler in subjects with asthma

D5125C00346

Protective effect of single doses of formoterol HFA pMDI compared with Oxis Turbuhaler and placebo on exercise-induced bronchoconstriction (EIB) in asthmatic children, 6-11 years of age.

SD-037-0738

Tolerability of high dose formoterol vs high dose terbutaline in asthmatic children after inhalation via Turbuhaler

SD-037-0714

A 12-month comparison of Oxis (formoterol) Turbuhaler and Bricanyl (terbutaline) Turbuhaler both used as needed in patients with asthma on anti-inflammatory treatment.

SD-037-0716

A 12-month comparion of OxisÒ (formoterol) TurbuhalerÒ and BricanylÒ (terbutaline) TurbuhalerÒ both used as needed in subjects with asthma not using anti-inflammatory treatment.

SD-037-0739

A six months, randomised, open, parallel group, multicentre study to examine efficacy and safety of as needed versus maintenance use of Oxis Turbuhaler (formoterol) 9 mg in subjects well controlled on maintenance treatment with inhaled corticosteroids and long-acting b2-agonist.

SD-037-0709

A 6-month study to compare the efficacy and safety of 9 mg formoterol(Oxis) Turbuhaler b.i.d. with placebo b.i.d. in patients with Chronic Obstructive Pulmonary Disease (COPD). Furthermore to compare formoterol 4.5 mg as needed with terbutaline 0.5 mg as needed.

SD-037-0718

A comparison of efficacy between formoterol Turbuhaler and salbutamol pressurized metered dose inhaler and spacer, in subjects with acute severe bronchial obstruction

37-3040

Protective effect of salbutamol against methacholine bromide in asthmatic patients pre-treated with formoterol Turbuhaler or salmeterol Diskhaler.

SD-037-0699

Real life effectiveness of Oxis Turbuhaler as needed in asthmatic patients during six months (RELIEF)

SD-037-0695

A 6 months comparison of the safety and efficacy profiles of Oxis (formoterol) Turbuhaler as needed and Bricanyl (terbutaline) Turbuhaler as needed in children with asthma on anti-inflammatory treatment
SD-037-0684On the bronchodilating effect of inhaled (R;R)- and (S;S)- formoterol compared with the bronchodilating effect of inhaled rac-formoterol in asthmatic patients
SD-037-0345Oxis (formoterol) and Pulmicort (budesonide) Turbuhaler in the management of asthma - OPTIMA
SD-037-0287A double-blind, randomized, placebo controlled cross-over study to compare the bronchodilatory effect of formoterol inhaled via two different Turbuhaler devices

SD-037-0708

Lung deposition and efficacy of formoterol inhaled via Turbuhaler® in patients with chronic obstructive pulmonary disease (COPD)

SD-037-0724

Comparison of formoterol (Oxis® ) via Turbuhaler® with salbutamol via pressurized metered dose inhaler and spacer in subjects with acute asthma presenting to the Emergency Department

BN-00D-0047

A randomized single blind comparison between formoterol, inhaled via Turbuhaler and inhaled via a pressurized Metered Dose Inhaler, connected to a large volume spacer, used as bronchodilator in patients with acute and severe airway obstruction, visiting the emergency department.

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