A 24-week (+ 24 week extension), randomised, 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 Inhalation (25 µg) 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), randomised, 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 Inhalation (25 µg) 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 Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 24 Oct 2012 Planned number of patients changed from 1800 to 2000 as reported by EudraCT record.
    • 15 Mar 2012 Planned number of patients changed from 220 to 1800 as reported by European Clinical Trials Database.
    • 13 Jul 2011 Additional trial locations identified as reported by ClinicalTrials.gov.
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