A 24-week (+ 24 week extension), randomized, placebo-controlled (only 1st 12-week period), double–blind, parallel-group, efficacy and safety comparison of Tiotropium/Salmeterol (7.5 µg/25 µg) Inhalation Powder in the morning (PE capsule via tiotropium/salmeterol HandiHaler), Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva HandiHaler), Salmeterol (25 µg) Inhalation Powder in the morning and evening (PE capsule via tiotropium/salmeterol HandiHaler) and Tiotropium/Salmeterol (7.5 µg/25 µg) Inhalation Powder in the morning (PE capsule via tiotropium/salmeterol HandiHaler) plus Salmeterol (25 µg) Inhalation Powder in the evening (PE capsule via tiotropium/salmeterol HandiHaler) in patients with COPD

Trial Profile

A 24-week (+ 24 week extension), randomized, placebo-controlled (only 1st 12-week period), double–blind, parallel-group, efficacy and safety comparison of Tiotropium/Salmeterol (7.5 µg/25 µg) Inhalation Powder in the morning (PE capsule via tiotropium/salmeterol HandiHaler), Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva HandiHaler), Salmeterol (25 µg) Inhalation Powder in the morning and evening (PE capsule via tiotropium/salmeterol HandiHaler) and Tiotropium/Salmeterol (7.5 µg/25 µg) Inhalation Powder in the morning (PE capsule via tiotropium/salmeterol HandiHaler) plus Salmeterol (25 µg) Inhalation Powder in the evening (PE capsule via tiotropium/salmeterol HandiHaler) in patients with COPD

Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2017

At a glance

  • Drugs Salmeterol/tiotropium bromide (Primary) ; Salmeterol; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 28 Apr 2012 Planned number of patients changed from 205 to 1800 as reported by European Clinical Trials Database record.
    • 30 Oct 2008 Planned number of patients changed from 140 to 205 as reported by ClinicalTrials.gov.
    • 30 Oct 2008 Planned end date changed from 1 Aug 2009 to 1 Oct 2008 as reported by ClinicalTrials.gov.
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