Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol PE Capsule) in COPD

Official Title: “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 by the SGRQ and the effect on COPD exacerbations.

Intervention(s) in this Clinical Trial

• Drug: Tiotropium/Salmeterol QD
  • Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
• Drug: Placebo
  • Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
• Drug: Salmeterol
  • Salmeterol Inhalation Powder, hard PE capsule
• Drug: Tiotropium/Salmeterol QD+ Salmeterol
  • Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
• Drug: Tiotropium
  • Tiotropium

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Tiotropium/Salmeterol QD
  • Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
• Active Comparator: Tiotropium QD
  • Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
• Active Comparator: Salmeterol BID
  • Salmeterol Inhalation Powder, hard PE capsule
• Active Comparator: Tiotropium/Salmeterol QD+ Salmeterol
  • Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
• Placebo Comparator: Placebo
  • Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Primary Measures

• Trough FEV1 response
  • Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
    Safety Issue?: No
• FEV1AUC 0 8h response
  • Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
    Safety Issue?: No
• Mahler TDI focal score
  • Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
    Safety Issue?: No
• SGRQ total score
  • Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
    Safety Issue?: No
• Time to first moderate to severe COPD exacerbation
  • Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
    Safety Issue?: No

Secondary Measures

• Trough FVC response
  • Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks
    Safety Issue?: No
• FVCAUC 0 8h response
  • Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks
    Safety Issue?: No
• PEF
  • Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks
    Safety Issue?: No
• use of rescue medication
  • Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks
    Safety Issue?: No
• COPD related night time awakenings
  • Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks
    Safety Issue?: No

Inclusion criteria:

Main:

• Diagnosis of COPD Post-bronchodilator FEV1<80% predicted and FEV1/FVC<70% predicted

Exclusion criteria:

Main:

• Significant other diseases then COPD Recent MI Unstable or life-threatening arrythmia requiring intervention or change in drug therapy Hospitalisation for cardiac failure in past year History of asthma

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662740

Study ID Number: 1184.14

ClinicalTrials.gov Identifier: NCT00662740

Health Authority: Austria: Federal Office for Safety in Health Care