Tiotropium/Salmeterol Inhalation Powder in COPD

Phase 3

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium/Salmeterol; Drug: Tiotropium; Drug: Salmeterol; Drug: Placebo; Drug: Tiotropium/Salmeterol QD + Salmeterol

• Registration Number: NCT00668772
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-15
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Primary Completion: 2008-11-21
• Study Completion: 2008-11-21
• Disposition First Submitted: 2014-04-30
• Disposition First Submitted QC: 2014-04-30
• Disposition First Posted: 2014-05-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-05
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium/Salmeterol QD	Tiotropium/Salmeterol	Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Tiotropium QD	Tiotropium	Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Salmeterol BID	Salmeterol	Salmeterol Inhalation Powder, hard PE capsule
Placebo	Placebo	Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Tiotropium/Salmeterol QD + Salmeterol	Tiotropium/Salmeterol QD + Salmeterol	Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Primary Outcome Measures

Name	Time	Method
Trough FEV1 response	12 Weeks, 24 Weeks and 48 Weeks
FEV1AUC 0 8hr response	12 Weeks, 24 Weeks and 48 Weeks
SGRQ total score	12 Weeks, 24 Weeks and 48 Weeks
Mahler TDI focal score	12 Weeks, 24 Weeks and 48 Weeks
Time to first moderate to severe COPD exacerbation	12 Weeks, 24 Weeks and 48 Weeks

Secondary Outcome Measures

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

Trial Locations

Locations (64)

1184.15.37153 Boehringer Ingelheim Investigational Site; 🇱🇻 Tukums, Latvia

1184.15.01071 Boehringer Ingelheim Investigational Site; 🇺🇸 Mobile, Alabama, United States

1184.15.45054 Boehringer Ingelheim Investigational Site; 🇩🇰 Aalborg, Denmark

1184.15.45052 Boehringer Ingelheim Investigational Site; 🇩🇰 Kolding, Denmark

1184.15.45053 Boehringer Ingelheim Investigational Site; 🇩🇰 Silkeborg, Denmark

1184.15.49058 Boehringer Ingelheim Investigational Site; 🇩🇪 Hannover, Germany

1184.15.02053 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

1184.15.01069 Boehringer Ingelheim Investigational Site; 🇺🇸 Anniston, Alabama, United States

1184.15.02060 Boehringer Ingelheim Investigational Site; 🇨🇦 Longueuil, Quebec, Canada

1184.15.36053 Boehringer Ingelheim Investigational Site; 🇭🇺 Erd, Hungary

1184.15.01070 Boehringer Ingelheim Investigational Site; 🇺🇸 New York, New York, United States

1184.15.02056 Boehringer Ingelheim Investigational Site; 🇨🇦 Montreal, Quebec, Canada

1184.15.36054 Boehringer Ingelheim Investigational Site; 🇭🇺 Szarvas, Hungary

1184.15.01051 Boehringer Ingelheim Investigational Site; 🇺🇸 Morgantown, West Virginia, United States

1184.15.45051 Boehringer Ingelheim Investigational Site; 🇩🇰 Odense C, Denmark

1184.15.02058 Boehringer Ingelheim Investigational Site; 🇨🇦 Ottawa, Ontario, Canada

1184.15.37154 Boehringer Ingelheim Investigational Site; 🇱🇻 Balvi, Latvia

1184.15.36052 Boehringer Ingelheim Investigational Site; 🇭🇺 Szeged, Hungary

1184.15.39051 Boehringer Ingelheim Investigational Site; 🇮🇹 Firenze, Italy

1184.15.27051; 🇿🇦 Bellville, South Africa

1184.15.82051 Boehringer Ingelheim Investigational Site; 🇰🇷 Jeonju, Korea, Republic of

1184.15.36055 Boehringer Ingelheim Investigational Site; 🇭🇺 Deszk, Hungary

1184.15.82052 Boehringer Ingelheim Investigational Site; 🇰🇷 Suwon, Korea, Republic of

1184.15.46053 Boehringer Ingelheim Investigational Site; 🇸🇪 Boden, Sweden

1184.15.02051 Boehringer Ingelheim Investigational Site; 🇨🇦 Scarborough, Ontario, Canada

1184.15.27053; 🇿🇦 Somerset West, South Africa

1184.15.01055 Boehringer Ingelheim Investigational Site; 🇺🇸 Saint Louis, Missouri, United States

1184.15.01054 Boehringer Ingelheim Investigational Site; 🇺🇸 Clearwater, Florida, United States

1184.15.01065 Boehringer Ingelheim Investigational Site; 🇺🇸 Savannah, Georgia, United States

1184.15.01062 Boehringer Ingelheim Investigational Site; 🇺🇸 Saint Louis, Missouri, United States

1184.15.01053 Boehringer Ingelheim Investigational Site; 🇺🇸 Albuquerque, New Mexico, United States

1184.15.35852 Boehringer Ingelheim Investigational Site; 🇫🇮 Oulu, Finland

1184.15.35851 Boehringer Ingelheim Investigational Site; 🇫🇮 Tampere, Finland

1184.15.49056 Boehringer Ingelheim Investigational Site; 🇩🇪 Aschaffenburg, Germany

1184.15.49057 Boehringer Ingelheim Investigational Site; 🇩🇪 Gelnhausen, Germany

1184.15.49053 Boehringer Ingelheim Investigational Site; 🇩🇪 Frankfurt, Germany

1184.15.49052 Boehringer Ingelheim Investigational Site; 🇩🇪 Hannover, Germany

1184.15.82053 Boehringer Ingelheim Investigational Site; 🇰🇷 Wonju, Korea, Republic of

1184.15.37152 Boehringer Ingelheim Investigational Site; 🇱🇻 Jelgava, Latvia

1184.15.31051 Boehringer Ingelheim Investigational Site; 🇳🇱 Breda, Netherlands

1184.15.31052 Boehringer Ingelheim Investigational Site; 🇳🇱 Zutphen, Netherlands

1184.15.37053 Boehringer Ingelheim Investigational Site; 🇱🇹 Klaipeda, Lithuania

1184.15.31054 Boehringer Ingelheim Investigational Site; 🇳🇱 Utrecht, Netherlands

1184.15.27052; 🇿🇦 Cape Town, South Africa

1184.15.46051 Boehringer Ingelheim Investigational Site; 🇸🇪 Stockholm, Sweden

1184.15.01057 Boehringer Ingelheim Investigational Site; 🇺🇸 Elizabeth City, North Carolina, United States

1184.15.01072 Boehringer Ingelheim Investigational Site; 🇺🇸 Summit, New Jersey, United States

1184.15.01058 Boehringer Ingelheim Investigational Site; 🇺🇸 Saint Louis, Missouri, United States

1184.15.02055 Boehringer Ingelheim Investigational Site; 🇨🇦 Hamilton, Ontario, Canada

1184.15.3350A Boehringer Ingelheim Investigational Site; 🇫🇷 Marseille, France

1184.15.3351A Boehringer Ingelheim Investigational Site; 🇫🇷 Nantes, France

1184.15.3352A Boehringer Ingelheim Investigational Site; 🇫🇷 Paris, France

1184.15.43052 Boehringer Ingelheim Investigational Site; 🇦🇹 Gänserndorf, Austria

1184.15.43053 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1184.15.37252 Boehringer Ingelheim Investigational Site; 🇪🇪 Kohtla-Jarve, Estonia

1184.15.37251 Boehringer Ingelheim Investigational Site; 🇪🇪 Tallin, Estonia

1184.15.02057 Boehringer Ingelheim Investigational Site; 🇨🇦 Vancouver, British Columbia, Canada

1184.15.02059 Boehringer Ingelheim Investigational Site; 🇨🇦 Vancouver, British Columbia, Canada

1184.15.42153 Boehringer Ingelheim Investigational Site; 🇸🇰 Bratislava, Slovakia

1184.15.42154 Boehringer Ingelheim Investigational Site; 🇸🇰 Bratislava, Slovakia

1184.15.01063 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

1184.15.01064 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

1184.15.01052 Boehringer Ingelheim Investigational Site; 🇺🇸 New Orleans, Louisiana, United States

1184.15.01059 Boehringer Ingelheim Investigational Site; 🇺🇸 Charleston, South Carolina, United States