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Tiotropium/Salmeterol Inhalation Powder in COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tiotropium/Salmeterol
Tiotropium/Salmeterol QD + Salmeterol
Placebo
Salmeterol
Tiotropium
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year Hospitalisation for cardiac failure during the past year History of asthma

Sites / Locations

  • 1184.15.01069 Boehringer Ingelheim Investigational Site
  • 1184.15.01071 Boehringer Ingelheim Investigational Site
  • 1184.15.01054 Boehringer Ingelheim Investigational Site
  • 1184.15.01063 Boehringer Ingelheim Investigational Site
  • 1184.15.01064 Boehringer Ingelheim Investigational Site
  • 1184.15.01065 Boehringer Ingelheim Investigational Site
  • 1184.15.01052 Boehringer Ingelheim Investigational Site
  • 1184.15.01055 Boehringer Ingelheim Investigational Site
  • 1184.15.01058 Boehringer Ingelheim Investigational Site
  • 1184.15.01062 Boehringer Ingelheim Investigational Site
  • 1184.15.01072 Boehringer Ingelheim Investigational Site
  • 1184.15.01053 Boehringer Ingelheim Investigational Site
  • 1184.15.01070 Boehringer Ingelheim Investigational Site
  • 1184.15.01057 Boehringer Ingelheim Investigational Site
  • 1184.15.01059 Boehringer Ingelheim Investigational Site
  • 1184.15.01051 Boehringer Ingelheim Investigational Site
  • 1184.15.43052 Boehringer Ingelheim Investigational Site
  • 1184.15.43053 Boehringer Ingelheim Investigational Site
  • 1184.15.02057 Boehringer Ingelheim Investigational Site
  • 1184.15.02059 Boehringer Ingelheim Investigational Site
  • 1184.15.02055 Boehringer Ingelheim Investigational Site
  • 1184.15.02058 Boehringer Ingelheim Investigational Site
  • 1184.15.02051 Boehringer Ingelheim Investigational Site
  • 1184.15.02053 Boehringer Ingelheim Investigational Site
  • 1184.15.02060 Boehringer Ingelheim Investigational Site
  • 1184.15.02056 Boehringer Ingelheim Investigational Site
  • 1184.15.45054 Boehringer Ingelheim Investigational Site
  • 1184.15.45052 Boehringer Ingelheim Investigational Site
  • 1184.15.45051 Boehringer Ingelheim Investigational Site
  • 1184.15.45053 Boehringer Ingelheim Investigational Site
  • 1184.15.37252 Boehringer Ingelheim Investigational Site
  • 1184.15.37251 Boehringer Ingelheim Investigational Site
  • 1184.15.35852 Boehringer Ingelheim Investigational Site
  • 1184.15.35851 Boehringer Ingelheim Investigational Site
  • 1184.15.3350A Boehringer Ingelheim Investigational Site
  • 1184.15.3351A Boehringer Ingelheim Investigational Site
  • 1184.15.3352A Boehringer Ingelheim Investigational Site
  • 1184.15.49056 Boehringer Ingelheim Investigational Site
  • 1184.15.49053 Boehringer Ingelheim Investigational Site
  • 1184.15.49057 Boehringer Ingelheim Investigational Site
  • 1184.15.49052 Boehringer Ingelheim Investigational Site
  • 1184.15.49058 Boehringer Ingelheim Investigational Site
  • 1184.15.36055 Boehringer Ingelheim Investigational Site
  • 1184.15.36053 Boehringer Ingelheim Investigational Site
  • 1184.15.36054 Boehringer Ingelheim Investigational Site
  • 1184.15.36052 Boehringer Ingelheim Investigational Site
  • 1184.15.39051 Boehringer Ingelheim Investigational Site
  • 1184.15.82051 Boehringer Ingelheim Investigational Site
  • 1184.15.82052 Boehringer Ingelheim Investigational Site
  • 1184.15.82053 Boehringer Ingelheim Investigational Site
  • 1184.15.37154 Boehringer Ingelheim Investigational Site
  • 1184.15.37152 Boehringer Ingelheim Investigational Site
  • 1184.15.37153 Boehringer Ingelheim Investigational Site
  • 1184.15.37053 Boehringer Ingelheim Investigational Site
  • 1184.15.31051 Boehringer Ingelheim Investigational Site
  • 1184.15.31054 Boehringer Ingelheim Investigational Site
  • 1184.15.31052 Boehringer Ingelheim Investigational Site
  • 1184.15.42153 Boehringer Ingelheim Investigational Site
  • 1184.15.42154 Boehringer Ingelheim Investigational Site
  • 1184.15.27051
  • 1184.15.27052
  • 1184.15.27053
  • 1184.15.46053 Boehringer Ingelheim Investigational Site
  • 1184.15.46051 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Tiotropium/Salmeterol QD

Tiotropium QD

Salmeterol BID

Tiotropium/Salmeterol QD + Salmeterol

Placebo

Arm Description

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Salmeterol Inhalation Powder, hard PE capsule

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Outcomes

Primary Outcome Measures

Trough FEV1 response
FEV1AUC 0 8hr response
Mahler TDI focal score
SGRQ total score
Time to first moderate to severe COPD exacerbation

Secondary Outcome Measures

Trough FEV1 response
FEV1 AUC0-8h response
Peak FEV1 response
Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)
Weekly mean number of COPD related night time awakenings
FVC (forced vital capacity) AUC0-8h and trough FVC response
Individual FEV1, FVC and PEF measurements
Weekly mean morning pre-dose and evening pre-dose PEFs (peak expiratory flow) and FEV1 (recorded by AM2+); PEFs determined by spirometry ]
Mahler TDI focal score
Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)
SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ
All adverse events
Vital signs: pulse rate and blood pressure
Routine blood chemistry, haematology and urinalysis
Vital status of randomised patients
Number of days in hospital (including ambulance transportation
Number of unscheduled health care provider visits
Number of visits in emergency room (including ambulance transportation)
Number of days in intensive care unit
Concomitant medications (for instance antibiotics and systemic steroids)

Full Information

First Posted
April 17, 2008
Last Updated
April 30, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00668772
Brief Title
Tiotropium/Salmeterol Inhalation Powder in COPD
Official Title
1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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 bt the SGRQ and the effect on COPD exacerbations

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tiotropium/Salmeterol QD
Arm Type
Experimental
Arm Description
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Arm Title
Tiotropium QD
Arm Type
Active Comparator
Arm Description
Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Arm Title
Salmeterol BID
Arm Type
Active Comparator
Arm Description
Salmeterol Inhalation Powder, hard PE capsule
Arm Title
Tiotropium/Salmeterol QD + Salmeterol
Arm Type
Active Comparator
Arm Description
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Intervention Type
Drug
Intervention Name(s)
Tiotropium/Salmeterol
Intervention Description
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Intervention Type
Drug
Intervention Name(s)
Tiotropium/Salmeterol QD + Salmeterol
Intervention Description
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Intervention Description
Salmeterol Inhalation Powder, hard PE capsule
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Primary Outcome Measure Information:
Title
Trough FEV1 response
Time Frame
12 Weeks, 24 Weeks and 48 Weeks
Title
FEV1AUC 0 8hr response
Time Frame
12 Weeks, 24 Weeks and 48 Weeks
Title
Mahler TDI focal score
Time Frame
12 Weeks, 24 Weeks and 48 Weeks
Title
SGRQ total score
Time Frame
12 Weeks, 24 Weeks and 48 Weeks
Title
Time to first moderate to severe COPD exacerbation
Time Frame
12 Weeks, 24 Weeks and 48 Weeks
Secondary Outcome Measure Information:
Title
Trough FEV1 response
Time Frame
4, 36 and 48 weeks
Title
FEV1 AUC0-8h response
Time Frame
4, 36 and 48 weeks
Title
Peak FEV1 response
Time Frame
12, 24, 36 and 48 weeks
Title
Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)
Time Frame
24 hours
Title
Weekly mean number of COPD related night time awakenings
Time Frame
1 week
Title
FVC (forced vital capacity) AUC0-8h and trough FVC response
Time Frame
48 weeks
Title
Individual FEV1, FVC and PEF measurements
Time Frame
48 weeks
Title
Weekly mean morning pre-dose and evening pre-dose PEFs (peak expiratory flow) and FEV1 (recorded by AM2+); PEFs determined by spirometry ]
Time Frame
48 weeks
Title
Mahler TDI focal score
Time Frame
4, 36 and 48 weeks
Title
Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)
Time Frame
4, 12, 24, 36 and 48 weeks
Title
SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ
Time Frame
4, 12, 36 and 48 weeks
Title
All adverse events
Time Frame
48 weeks
Title
Vital signs: pulse rate and blood pressure
Time Frame
Baseline and 4 weeks
Title
Routine blood chemistry, haematology and urinalysis
Time Frame
Baseline and 48 weeks
Title
Vital status of randomised patients
Time Frame
48 weeks
Title
Number of days in hospital (including ambulance transportation
Time Frame
48 weeks
Title
Number of unscheduled health care provider visits
Time Frame
48 weeks
Title
Number of visits in emergency room (including ambulance transportation)
Time Frame
48 weeks
Title
Number of days in intensive care unit
Time Frame
48 weeks
Title
Concomitant medications (for instance antibiotics and systemic steroids)
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year Hospitalisation for cardiac failure during the past year History of asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1184.15.01069 Boehringer Ingelheim Investigational Site
City
Anniston
State/Province
Alabama
Country
United States
Facility Name
1184.15.01071 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
1184.15.01054 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1184.15.01063 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1184.15.01064 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1184.15.01065 Boehringer Ingelheim Investigational Site
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
1184.15.01052 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
1184.15.01055 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1184.15.01058 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1184.15.01062 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1184.15.01072 Boehringer Ingelheim Investigational Site
City
Summit
State/Province
New Jersey
Country
United States
Facility Name
1184.15.01053 Boehringer Ingelheim Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
1184.15.01070 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1184.15.01057 Boehringer Ingelheim Investigational Site
City
Elizabeth City
State/Province
North Carolina
Country
United States
Facility Name
1184.15.01059 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1184.15.01051 Boehringer Ingelheim Investigational Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
1184.15.43052 Boehringer Ingelheim Investigational Site
City
Gänserndorf
Country
Austria
Facility Name
1184.15.43053 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1184.15.02057 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1184.15.02059 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1184.15.02055 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1184.15.02058 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1184.15.02051 Boehringer Ingelheim Investigational Site
City
Scarborough
State/Province
Ontario
Country
Canada
Facility Name
1184.15.02053 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1184.15.02060 Boehringer Ingelheim Investigational Site
City
Longueuil
State/Province
Quebec
Country
Canada
Facility Name
1184.15.02056 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1184.15.45054 Boehringer Ingelheim Investigational Site
City
Aalborg
Country
Denmark
Facility Name
1184.15.45052 Boehringer Ingelheim Investigational Site
City
Kolding
Country
Denmark
Facility Name
1184.15.45051 Boehringer Ingelheim Investigational Site
City
Odense C
Country
Denmark
Facility Name
1184.15.45053 Boehringer Ingelheim Investigational Site
City
Silkeborg
Country
Denmark
Facility Name
1184.15.37252 Boehringer Ingelheim Investigational Site
City
Kohtla-Jarve
Country
Estonia
Facility Name
1184.15.37251 Boehringer Ingelheim Investigational Site
City
Tallin
Country
Estonia
Facility Name
1184.15.35852 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
1184.15.35851 Boehringer Ingelheim Investigational Site
City
Tampere
Country
Finland
Facility Name
1184.15.3350A Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
1184.15.3351A Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1184.15.3352A Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1184.15.49056 Boehringer Ingelheim Investigational Site
City
Aschaffenburg
Country
Germany
Facility Name
1184.15.49053 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
1184.15.49057 Boehringer Ingelheim Investigational Site
City
Gelnhausen
Country
Germany
Facility Name
1184.15.49052 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1184.15.49058 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1184.15.36055 Boehringer Ingelheim Investigational Site
City
Deszk
Country
Hungary
Facility Name
1184.15.36053 Boehringer Ingelheim Investigational Site
City
Erd
Country
Hungary
Facility Name
1184.15.36054 Boehringer Ingelheim Investigational Site
City
Szarvas
Country
Hungary
Facility Name
1184.15.36052 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
1184.15.39051 Boehringer Ingelheim Investigational Site
City
Firenze
Country
Italy
Facility Name
1184.15.82051 Boehringer Ingelheim Investigational Site
City
Jeonju
Country
Korea, Republic of
Facility Name
1184.15.82052 Boehringer Ingelheim Investigational Site
City
Suwon
Country
Korea, Republic of
Facility Name
1184.15.82053 Boehringer Ingelheim Investigational Site
City
Wonju
Country
Korea, Republic of
Facility Name
1184.15.37154 Boehringer Ingelheim Investigational Site
City
Balvi
Country
Latvia
Facility Name
1184.15.37152 Boehringer Ingelheim Investigational Site
City
Jelgava
Country
Latvia
Facility Name
1184.15.37153 Boehringer Ingelheim Investigational Site
City
Tukums
Country
Latvia
Facility Name
1184.15.37053 Boehringer Ingelheim Investigational Site
City
Klaipeda
Country
Lithuania
Facility Name
1184.15.31051 Boehringer Ingelheim Investigational Site
City
Breda
Country
Netherlands
Facility Name
1184.15.31054 Boehringer Ingelheim Investigational Site
City
Utrecht
Country
Netherlands
Facility Name
1184.15.31052 Boehringer Ingelheim Investigational Site
City
Zutphen
Country
Netherlands
Facility Name
1184.15.42153 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
1184.15.42154 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
1184.15.27051
City
Bellville
Country
South Africa
Facility Name
1184.15.27052
City
Cape Town
Country
South Africa
Facility Name
1184.15.27053
City
Somerset West
Country
South Africa
Facility Name
1184.15.46053 Boehringer Ingelheim Investigational Site
City
Boden
Country
Sweden
Facility Name
1184.15.46051 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Tiotropium/Salmeterol Inhalation Powder in COPD

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