Tiotropium/Salmeterol Inhalation Powder in COPD

NCT00668772 | Terminated Phase 3

• 2 other identifiers: 1184.152007-005107-17
• Study Type: interventional
• Target: 207
• Locations: 17 countries
• Sites: 64

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (5)

• Trough FEV1 response

  12 Weeks, 24 Weeks and 48 Weeks

• FEV1AUC 0 8hr response

  12 Weeks, 24 Weeks and 48 Weeks

• Mahler TDI focal score

  12 Weeks, 24 Weeks and 48 Weeks

• 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)

• Trough FEV1 response

  4, 36 and 48 weeks

• FEV1 AUC0-8h 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

• Weekly mean number of COPD related night time awakenings

  1 week

Study Arms (5)

Tiotropium/Salmeterol QD

EXPERIMENTAL

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Drug: Tiotropium/Salmeterol

Tiotropium QD

ACTIVE COMPARATOR

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Drug: Tiotropium

Salmeterol BID

ACTIVE COMPARATOR

Salmeterol Inhalation Powder, hard PE capsule

Drug: Salmeterol

Tiotropium/Salmeterol QD + Salmeterol

ACTIVE COMPARATOR

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

Drug: Tiotropium/Salmeterol QD + Salmeterol

Placebo

PLACEBO COMPARATOR

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Drug: Placebo

Interventions

Tiotropium/Salmeterol DRUG

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Tiotropium/Salmeterol QD

Tiotropium/Salmeterol QD + Salmeterol DRUG

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

Tiotropium/Salmeterol QD + Salmeterol

Placebo DRUG

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Placebo

Salmeterol DRUG

Salmeterol Inhalation Powder, hard PE capsule

Salmeterol BID

Tiotropium DRUG

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Tiotropium QD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (64)

1184.15.01069 Boehringer Ingelheim Investigational Site

Anniston, Alabama, United States

Location

1184.15.01071 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1184.15.01054 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1184.15.01063 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1184.15.01064 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1184.15.01065 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Location

1184.15.01052 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

1184.15.01055 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1184.15.01058 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1184.15.01062 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1184.15.01072 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

Location

1184.15.01053 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1184.15.01070 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1184.15.01057 Boehringer Ingelheim Investigational Site

Elizabeth City, North Carolina, United States

Location

1184.15.01059 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1184.15.01051 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Location

1184.15.43052 Boehringer Ingelheim Investigational Site

Gänserndorf, Austria

Location

1184.15.43053 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1184.15.02057 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1184.15.02059 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1184.15.02055 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1184.15.02058 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1184.15.02051 Boehringer Ingelheim Investigational Site

Scarborough Village, Ontario, Canada

Location

1184.15.02053 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1184.15.02060 Boehringer Ingelheim Investigational Site

Longueuil, Quebec, Canada

Location

1184.15.02056 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1184.15.45054 Boehringer Ingelheim Investigational Site

Aalborg, Denmark

Location

1184.15.45052 Boehringer Ingelheim Investigational Site

Kolding, Denmark

Location

1184.15.45051 Boehringer Ingelheim Investigational Site

Odense C, Denmark

Location

1184.15.45053 Boehringer Ingelheim Investigational Site

Silkeborg, Denmark

Location

1184.15.37252 Boehringer Ingelheim Investigational Site

Kohtla-Järve, Estonia

Location

1184.15.37251 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1184.15.35852 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1184.15.35851 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

1184.15.3350A Boehringer Ingelheim Investigational Site

Marseille, France

Location

1184.15.3351A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1184.15.3352A Boehringer Ingelheim Investigational Site

Paris, France

Location

1184.15.49056 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

Location

1184.15.49053 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1184.15.49057 Boehringer Ingelheim Investigational Site

Gelnhausen, Germany

Location

1184.15.49052 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1184.15.49058 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1184.15.36055 Boehringer Ingelheim Investigational Site

Deszk, Hungary

Location

1184.15.36053 Boehringer Ingelheim Investigational Site

Érd, Hungary

Location

1184.15.36054 Boehringer Ingelheim Investigational Site

Szarvas, Hungary

Location

1184.15.36052 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

1184.15.39051 Boehringer Ingelheim Investigational Site

Florence, Italy

Location

1184.15.37154 Boehringer Ingelheim Investigational Site

Balvi, Latvia

Location

1184.15.37152 Boehringer Ingelheim Investigational Site

Jelgava, Latvia

Location

1184.15.37153 Boehringer Ingelheim Investigational Site

Tukums, Latvia

Location

1184.15.37053 Boehringer Ingelheim Investigational Site

Klaipėda, Lithuania

Location

1184.15.31051 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1184.15.31054 Boehringer Ingelheim Investigational Site

Utrecht, Netherlands

Location

1184.15.31052 Boehringer Ingelheim Investigational Site

Zutphen, Netherlands

Location

1184.15.42153 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1184.15.42154 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1184.15.27051

Bellville, South Africa

Location

1184.15.27052

Cape Town, South Africa

Location

1184.15.27053

Somerset West, South Africa

Location

1184.15.82051 Boehringer Ingelheim Investigational Site

Jeonju, South Korea

Location

1184.15.82052 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1184.15.82053 Boehringer Ingelheim Investigational Site

Wŏnju, South Korea

Location

1184.15.46053 Boehringer Ingelheim Investigational Site

Boden, Sweden

Location

1184.15.46051 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

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 29, 2008
• Study Start: April 15, 2008
• Primary Completion: November 21, 2008
• Study Completion: November 21, 2008
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

SE (2); DE (5); FI (2); FR (3); US (16); ES (2); KR (3); CA (8); ZA (3); DK (4); SL (2); LA (3); NL (3); HU (4); IT (1); AU (2); LI (1)