Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)

August 18, 2023 updated by: Boehringer Ingelheim

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 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldbach, Austria
        • 1184.14.43001 Boehringer Ingelheim Investigational Site
  • Belgium
      • Brussel, Belgium
        • 1184.14.32001 Boehringer Ingelheim Investigational Site
      • Turnhout, Belgium
        • 1184.14.32004 Boehringer Ingelheim Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 1184.14.02005 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Chilliwack, British Columbia, Canada
        • 1184.14.02003 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 1184.14.02010 Boehringer Ingelheim Investigational Site
    • Ontario
      • Niagara Falls, Ontario, Canada
        • 1184.14.02001 Boehringer Ingelheim Investigational Site
    • Quebec
      • La Malbaie, Quebec, Canada
        • 1184.14.02002 Boehringer Ingelheim Investigational Site
      • Ste-Foy, Quebec, Canada
        • 1184.14.02008 Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 1184.14.02007 Boehringer Ingelheim Investigational Site
  • Denmark
      • Hvidovre, Denmark
        • 1184.14.45001 Boehringer Ingelheim Investigational Site
      • København NV, Denmark
        • 1184.14.45002 Boehringer Ingelheim Investigational Site
  • Estonia
      • Tallin, Estonia
        • 1184.14.37202 Boehringer Ingelheim Investigational Site
      • Tartu, Estonia
        • 1184.14.37201 Boehringer Ingelheim Investigational Site
  • Finland
      • Espoo, Finland
        • 1184.14.35802 Boehringer Ingelheim Investigational Site
      • HUS, Finland
        • 1184.14.35801 Boehringer Ingelheim Investigational Site
  • France
      • Brest, France
        • 1184.14.3301A Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1184.14.3304A Boehringer Ingelheim Investigational Site
      • Montpellier, France
        • 1184.14.3302A Boehringer Ingelheim Investigational Site
      • Perpignan, 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
  • Germany
      • Berlin, Germany
        • 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
      • Hamburg, Germany
        • 1184.14.49002 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1184.14.49007 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1184.14.49001 Boehringer Ingelheim Investigational Site
  • Greece
      • Athens, Greece
        • 1184.14.30001 Boehringer Ingelheim Investigational Site
      • Nafplio, Greece
        • 1184.14.30004 Boehringer Ingelheim Investigational Site
      • Rethymno, Greece
        • 1184.14.30006 Boehringer Ingelheim Investigational Site
  • Hungary
      • Debrecen, Hungary
        • 1184.14.36002 Boehringer Ingelheim Investigational Site
      • Hodmezövasarhely, Hungary
        • 1184.14.36001 Boehringer Ingelheim Investigational Site
      • Komlo, Hungary
        • 1184.14.36005 Boehringer Ingelheim Investigational Site
      • Miskolc, Hungary
        • 1184.14.36004 Boehringer Ingelheim Investigational Site
  • Italy
      • Pisa, Italy
        • 1184.14.39001 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • 1184.14.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1184.14.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1184.14.82003 Boehringer Ingelheim Investigational Site
  • Latvia
      • Kraslava, Latvia
        • 1184.14.37101 Boehringer Ingelheim Investigational Site
      • Kuldiga, Latvia
        • 1184.14.37103 Boehringer Ingelheim Investigational Site
      • Talsi, Latvia
        • 1184.14.37102 Boehringer Ingelheim Investigational Site
  • Lithuania
      • Klaipeda, Lithuania
        • 1184.14.37003 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Eindhoven, Netherlands
        • 1184.14.31004 Boehringer Ingelheim Investigational Site
      • Heerlen, Netherlands
        • 1184.14.31003 Boehringer Ingelheim Investigational Site
      • Nieuwegein, Netherlands
        • 1184.14.31002 Boehringer Ingelheim Investigational Site
      • Veldhoven, Netherlands
        • 1184.14.31001 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Bardejov, Slovakia
        • 1184.14.42103 Boehringer Ingelheim Investigational Site
  • Sweden
      • Linköping, Sweden
        • 1184.14.46002 Boehringer Ingelheim Investigational Site
      • Lund, Sweden
        • 1184.14.46001 Boehringer Ingelheim Investigational Site
      • Sundsvall, Sweden
        • 1184.14.46003 Boehringer Ingelheim Investigational Site
  • United States
    • Colorado
      • Boulder, Colorado, United States
        • 1184.14.01013 Boehringer Ingelheim Investigational Site
      • Wheat Ridge, Colorado, United States
        • 1184.14.01018 Boehringer Ingelheim Investigational Site
    • Florida
      • Winter Park, Florida, United States
        • 1184.14.01006 Boehringer Ingelheim Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States
        • 1184.14.01003 Boehringer Ingelheim Investigational Site
    • Indiana
      • South Bend, Indiana, United States
        • 1184.14.01015 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States
        • 1184.14.01007 Boehringer Ingelheim Investigational Site
    • Maine
      • Bangor, Maine, United States
        • 1184.14.01005 Boehringer Ingelheim Investigational Site
    • Minnesota
      • Edina, Minnesota, United States
        • 1184.14.01020 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Burlington, North Carolina, United States
        • 1184.14.01009 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1184.14.01002 Boehringer Ingelheim Investigational Site
      • Toledo, Ohio, United States
        • 1184.14.01021 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States
        • 1184.14.01012 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States
        • 1184.14.01017 Boehringer Ingelheim Investigational Site
      • Spartanburg, South Carolina, United States
        • 1184.14.01008 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, United States
        • 1184.14.01014 Boehringer Ingelheim Investigational Site
      • Killeen, Texas, United States
        • 1184.14.01022 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1184.14.01001 Boehringer Ingelheim Investigational Site
      • Temple, Texas, United States
        • 1184.14.01010 Boehringer Ingelheim Investigational Site
    • Virginia
      • Richmond, Virginia, United States
        • 1184.14.01011 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 1184.14.01019 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion criteria:

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

Main Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Drug: Placebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Experimental: Tiotropium/Salmeterol quaque die (QD, once daily)
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Drug: Tiotropium/Salmeterol QD
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Active Comparator: Tiotropium quaque die (QD, once daily)
Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Drug: Tiotropium (Spiriva®)
Tiotropium, Spiriva®
Active Comparator: Salmeterol bis in die (BID, twice daily)
Salmeterol Inhalation Powder, hard PE capsule
Drug: Salmeterol
Salmeterol Inhalation Powder, hard PE capsule
Active Comparator: Tiotropium/Salmeterol quaque die (QD, once daily)+ Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first moderate to severe COPD exacerbation
Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
12 Weeks, 24 Weeks and 48 Weeks
Trough forced expiratory volume in one second (FEV1) response
Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
12 Weeks, 24 Weeks and 48 Weeks
FEV1 area under the curve (AUC) 0-8h response
Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
12 Weeks, 24 Weeks and 48 Weeks
Mahler Transition Dyspnoea Index (TDI) focal score
Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
12 Weeks, 24 Weeks and 48 Weeks
St George Respiratory Questionnaire (SGRQ) total score
Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
12 Weeks, 24 Weeks and 48 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Trough FEV1 response
Time Frame: 4, 36 and 48 weeks
4, 36 and 48 weeks
Peak FEV1 response
Time Frame: 12, 24, 36 and 48 weeks
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)
Time Frame: 24 hours
24 hours
Weekly mean number of COPD related night time awakenings
Time Frame: 1 week
1 week
Mahler TDI focal score
Time Frame: 4, 36 and 48 weeks
4, 36 and 48 weeks
Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)
Time Frame: 4, 12, 24, 36 and 48 weeks
4, 12, 24, 36 and 48 weeks
SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ
Time Frame: 4, 12, 36 and 48 weeks
4, 12, 36 and 48 weeks
All adverse events
Time Frame: 48 weeks
48 weeks
Vital signs: pulse rate and blood pressure
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Routine blood chemistry, haematology and urinalysis
Time Frame: Baseline and 48 weeks
Baseline and 48 weeks
Vital status of randomised patients
Time Frame: 48 weeks
48 weeks
Number of days in hospital (including ambulance transportation
Time Frame: 48 weeks
48 weeks
Number of unscheduled health care provider visits
Time Frame: 48 weeks
48 weeks
Number of visits in emergency room (including ambulance transportation)
Time Frame: 48 weeks
48 weeks
Number of days in intensive care unit
Time Frame: 48 weeks
48 weeks
Concomitant medications (for instance antibiotics and systemic steroids).
Time Frame: 48 weeks
48 weeks
FEV1 AUC 0-8h response
Time Frame: 4, 36 and 48 weeks
4, 36 and 48 weeks
Forced vital capacity (FVC) AUC0-8h and trough FVC response
Time Frame: 48 weeks
48 weeks
Individual FEV1, FVC and peak expiratory flow (PEF) measurements
Time Frame: 48 weeks
48 weeks
Weekly mean morning pre-dose and evening pre-dose PEFs and FEV1 (recorded by Asthma Monitor® 2 (AM2+)); PEFs determined by spirometry ]
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2008

Primary Completion (Actual)

November 21, 2008

Study Completion (Actual)

November 21, 2008

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimated)

April 21, 2008

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1184.14
  • 2007-005134-36 (EudraCT Number: EudraCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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