Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)
1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)
2 other identifiers
interventional
220
18 countries
72
Brief Summary
The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2008
Shorter than P25 for phase_3
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2008
CompletedFirst Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2008
CompletedAugust 23, 2023
August 1, 2023
7 months
April 17, 2008
August 18, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Trough forced expiratory volume in one second (FEV1) response
12 Weeks, 24 Weeks and 48 Weeks
FEV1 area under the curve (AUC) 0-8h response
12 Weeks, 24 Weeks and 48 Weeks
Mahler Transition Dyspnoea Index (TDI) focal score
12 Weeks, 24 Weeks and 48 Weeks
St George Respiratory Questionnaire (SGRQ) total score
12 Weeks, 24 Weeks and 48 Weeks
Time to first moderate to severe COPD exacerbation
12 Weeks, 24 Weeks and 48 Weeks
Secondary Outcomes (20)
FEV1 AUC 0-8h response
4, 36 and 48 weeks
Trough FEV1 response
4, 36 and 48 weeks
Peak FEV1 response
12, 24, 36 and 48 weeks
Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)
24 hours
Forced vital capacity (FVC) AUC0-8h and trough FVC response
48 weeks
- +15 more secondary outcomes
Study Arms (5)
Tiotropium/Salmeterol quaque die (QD, once daily)
EXPERIMENTALTiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Tiotropium quaque die (QD, once daily)
ACTIVE COMPARATORTiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Salmeterol bis in die (BID, twice daily)
ACTIVE COMPARATORSalmeterol Inhalation Powder, hard PE capsule
Tiotropium/Salmeterol quaque die (QD, once daily)+ Salmeterol
ACTIVE COMPARATORTiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Placebo
PLACEBO COMPARATORPlacebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Interventions
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD
- Post-bronchodilator FEV1\<80% predicted and FEV1/FVC\<70% predicted
You may not qualify if:
- Significant other diseases then COPD
- Recent myocardial infarction (MI)
- Unstable or life-threatening arrythmia requiring intervention or change in drug therapy
- Hospitalisation for cardiac failure in past year
- History of asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
1184.14.01013 Boehringer Ingelheim Investigational Site
Boulder, Colorado, United States
1184.14.01018 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
1184.14.01006 Boehringer Ingelheim Investigational Site
Winter Park, Florida, United States
1184.14.01003 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
1184.14.01015 Boehringer Ingelheim Investigational Site
South Bend, Indiana, United States
1184.14.01007 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
1184.14.01005 Boehringer Ingelheim Investigational Site
Bangor, Maine, United States
1184.14.01020 Boehringer Ingelheim Investigational Site
Edina, Minnesota, United States
1184.14.01009 Boehringer Ingelheim Investigational Site
Burlington, North Carolina, United States
1184.14.01002 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1184.14.01021 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States
1184.14.01012 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island, United States
1184.14.01017 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1184.14.01008 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1184.14.01014 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1184.14.01022 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1184.14.01001 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1184.14.01010 Boehringer Ingelheim Investigational Site
Temple, Texas, United States
1184.14.01011 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1184.14.01019 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1184.14.43001 Boehringer Ingelheim Investigational Site
Feldbach, Austria
1184.14.32001 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1184.14.32004 Boehringer Ingelheim Investigational Site
Turnhout, Belgium
1184.14.02005 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1184.14.02003 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia, Canada
1184.14.02010 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1184.14.02001 Boehringer Ingelheim Investigational Site
Niagara Falls, Ontario, Canada
1184.14.02002 Boehringer Ingelheim Investigational Site
La Malbaie, Quebec, Canada
1184.14.02008 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec, Canada
1184.14.02007 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
1184.14.45001 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
1184.14.45002 Boehringer Ingelheim Investigational Site
København NV, Denmark
1184.14.37202 Boehringer Ingelheim Investigational Site
Tallinn, Estonia
1184.14.37201 Boehringer Ingelheim Investigational Site
Tartu, Estonia
1184.14.35802 Boehringer Ingelheim Investigational Site
Espoo, Finland
1184.14.35801 Boehringer Ingelheim Investigational Site
HUS, Finland
1184.14.3301A Boehringer Ingelheim Investigational Site
Brest, France
1184.14.3304A Boehringer Ingelheim Investigational Site
Marseille, France
1184.14.3302A Boehringer Ingelheim Investigational Site
Montpellier, France
1184.14.3303A Boehringer Ingelheim Investigational Site
Perpignan, France
1184.14.3303B Boehringer Ingelheim Investigational Site
Perpignan, France
1184.14.3303C Boehringer Ingelheim Investigational Site
Perpignan, France
1184.14.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
1184.14.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
1184.14.49006 Boehringer Ingelheim Investigational Site
Berlin, Germany
1184.14.49008 Boehringer Ingelheim Investigational Site
Berlin, Germany
1184.14.49002 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1184.14.49007 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1184.14.49001 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1184.14.30001 Boehringer Ingelheim Investigational Site
Athens, Greece
1184.14.30004 Boehringer Ingelheim Investigational Site
Nafplion, Greece
1184.14.30006 Boehringer Ingelheim Investigational Site
Rethymno, Greece
1184.14.36002 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
1184.14.36001 Boehringer Ingelheim Investigational Site
Hodmezövasarhely, Hungary
1184.14.36005 Boehringer Ingelheim Investigational Site
Komló, Hungary
1184.14.36004 Boehringer Ingelheim Investigational Site
Miskolc, Hungary
1184.14.39001 Boehringer Ingelheim Investigational Site
Pisa, Italy
1184.14.37101 Boehringer Ingelheim Investigational Site
Krāslava, Latvia
1184.14.37103 Boehringer Ingelheim Investigational Site
Kuldīga, Latvia
1184.14.37102 Boehringer Ingelheim Investigational Site
Talsi, Latvia
1184.14.37003 Boehringer Ingelheim Investigational Site
Klaipėda, Lithuania
1184.14.31004 Boehringer Ingelheim Investigational Site
Eindhoven, Netherlands
1184.14.31003 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands
1184.14.31002 Boehringer Ingelheim Investigational Site
Nieuwegein, Netherlands
1184.14.31001 Boehringer Ingelheim Investigational Site
Veldhoven, Netherlands
1184.14.42103 Boehringer Ingelheim Investigational Site
Bardejov, Slovakia
1184.14.82001 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1184.14.82002 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1184.14.82003 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1184.14.46002 Boehringer Ingelheim Investigational Site
Linköping, Sweden
1184.14.46001 Boehringer Ingelheim Investigational Site
Lund, Sweden
1184.14.46003 Boehringer Ingelheim Investigational Site
Sundsvall, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2008
First Posted
April 21, 2008
Study Start
April 15, 2008
Primary Completion
November 21, 2008
Study Completion
November 21, 2008
Last Updated
August 23, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.