A Randomised, Open-label, 4-way Crossover Study to Characterize the Pharmacokinetics, Safety and Efficacy of FDC Tiotropium/Salmeterol, Tiotropium, Salmeterol and a Free Combination of Tiotropium Plus Salmeterol Following 4-week Treatment Periods in Patients With COPD.

The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic obstructive pulmonary disease (COPD).

Start Date01 May 2008

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT00662792 / CompletedPhase 3

A Randomised, Double-blind Clinical Efficacy and Safety Comparison of Tiotropium/Salmeterol 7.5/25 Inhalation Powder in the Morning Via Tiotropium/Salmeterol HandiHaler, Tiotropium 18 Mcg Inhalation Powder in the Morning Via Spiriva HandiHaler, Salmeterol 50 Mcg MDPI in the Morning and Evening and the Free Combination Tiotropium 18 Mcg Inhalation Powder in the Morning Via Spiriva HandiHaler Plus Salmeterol 50 Mcg MDPI in the Morning and Evening Following Chronic Administration (6-week Treatment Periods) in Patients With COPD

The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung function response over the comparator treatments inhaled in their established dose regimens when administered for 6-week periods to patients with chronic obstructive pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.

Start Date15 Apr 2008

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT00668772 / TerminatedPhase 3

1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations

Start Date15 Apr 2008

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Salmeterol xinafoate/Tiotropium Bromide Hydrate

100 Translational Medicine associated with Salmeterol xinafoate/Tiotropium Bromide Hydrate

100 Patents (Medical) associated with Salmeterol xinafoate/Tiotropium Bromide Hydrate

Literatures (Medical) associated with Salmeterol xinafoate/Tiotropium Bromide Hydrate

01 Mar 2013·European Respiratory JournalQ1 · MEDICINE

Cost-effectiveness of tiotropiumversussalmeterol: the POET-COPD trial

Q1 · MEDICINE

Article

Author: Hoogendoorn, Martine ; Monz, Brigitta U ; Vogelmeier, Claus ; Graf von der Schulenburg, J Matthias ; Rutten-van Mölken, Maureen P M H ; Beeh, Kai-Michael ; Al, Maiwenn J ; Schmidt, Hendrik ; Lungershausen, Juliane ; Bowles, David

The aim of this study was to perform a 1-yr trial-based cost-effectiveness analysis (CEA) of tiotropiumversussalmeterol followed by a 5-yr model-based CEA.The within-trial CEA, including 7,250 patients with moderate to very severe chronic obstructive pulmonary disease (COPD), was performed alongside the 1-yr international randomised controlled Prevention of Exacerbations with Tiotropium (POET)-COPD trial comparing tiotropium with salmeterol regarding the effect on exacerbations. Main end-points of the trial-based analysis were costs, number of exacerbations and exacerbation days. The model-based analysis was conducted to extrapolate results to 5 yrs and to calculate quality-adjusted life years (QALYs).1-yr costs per patient from the German statutory health insurance (SHI) perspective and the societal perspective were €126 (95% uncertainty interval (UI) €55–195) and €170 (95% UI €77–260) higher for tiotropium, respectively. The annual number of exacerbations was 0.064 (95% UI 0.010–0.118) lower for tiotropium, leading to a reduction in exacerbation-related costs of €87 (95% UI €19–157). The incremental cost-effectiveness ratio was €1,961 per exacerbation avoided from the SHI perspective and €2,647 from the societal perspective. In the model-based analyses, the 5-yr costs per QALY were €3,488 from the SHI perspective and €8,141 from the societal perspective.Tiotropium reduced exacerbations and exacerbation-related costs, but increased total costs. Tiotropium can be considered cost-effective as the resulting cost-effectiveness ratios were below commonly accepted willingness-to-pay thresholds.

100 Deals associated with Salmeterol xinafoate/Tiotropium Bromide Hydrate

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	IND Application	CN	Boehringer Ingelheim International GmbH	10 Jan 2008
Pulmonary Disease, Chronic Obstructive	IND Application	CN	Meilaipu (Beijing) Pharmaceutical Research Co., Ltd.	10 Jan 2008
Pulmonary Disease, Chronic Obstructive	IND Application	CN	Boehringer Ingelheim Pharma GmbH & Co., KG	10 Jan 2008

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