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

Phase 3

Terminated

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium/Salmeterol QD
Drug: Tiotropium/Salmeterol QD+ Salmeterol
Drug: Placebo
Drug: Tiotropium (Spiriva®)
Drug: Salmeterol

Registration Number: NCT00662740

Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium/Salmeterol quaque die (QD, once daily)	Tiotropium/Salmeterol QD	Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Tiotropium/Salmeterol quaque die (QD, once daily)+ Salmeterol	Tiotropium/Salmeterol QD+ Salmeterol	Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Placebo	Placebo	Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Tiotropium quaque die (QD, once daily)	Tiotropium (Spiriva®)	Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Salmeterol bis in die (BID, twice daily)	Salmeterol	Salmeterol Inhalation Powder, hard PE capsule

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All adverse events	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
Routine blood chemistry, haematology and urinalysis	Baseline and 48 weeks
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
Individual FEV1, FVC and peak expiratory flow (PEF) measurements	48 weeks
Weekly mean morning pre-dose and evening pre-dose PEFs and FEV1 (recorded by Asthma Monitor® 2 (AM2+)); PEFs determined by spirometry ]	48 weeks
Weekly mean number of COPD related night time awakenings	1 week
Vital status of randomised patients	48 weeks
Mahler TDI focal score	4, 36 and 48 weeks
Vital signs: pulse rate and blood pressure	Baseline and 4 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
Concomitant medications (for instance antibiotics and systemic steroids).	48 weeks

Trial Locations

Locations (72): 1184.14.01006 Boehringer Ingelheim Investigational Site
🇺🇸
Winter Park, Florida, United States
1184.14.01015 Boehringer Ingelheim Investigational Site
🇺🇸
South Bend, Indiana, United States
1184.14.31001 Boehringer Ingelheim Investigational Site
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Veldhoven, Netherlands
1184.14.01001 Boehringer Ingelheim Investigational Site
🇺🇸
San Antonio, Texas, United States
1184.14.37202 Boehringer Ingelheim Investigational Site
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Tallin, Estonia
1184.14.37201 Boehringer Ingelheim Investigational Site
🇪🇪
Tartu, Estonia
1184.14.36001 Boehringer Ingelheim Investigational Site
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Hodmezövasarhely, Hungary
1184.14.36005 Boehringer Ingelheim Investigational Site
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Komlo, Hungary
1184.14.37103 Boehringer Ingelheim Investigational Site
🇱🇻
Kuldiga, Latvia
1184.14.37102 Boehringer Ingelheim Investigational Site
🇱🇻
Talsi, Latvia
1184.14.37003 Boehringer Ingelheim Investigational Site
🇱🇹
Klaipeda, Lithuania
1184.14.43001 Boehringer Ingelheim Investigational Site
🇦🇹
Feldbach, Austria
1184.14.30006 Boehringer Ingelheim Investigational Site
🇬🇷
Rethymno, Greece
1184.14.37101 Boehringer Ingelheim Investigational Site
🇱🇻
Kraslava, Latvia
1184.14.01003 Boehringer Ingelheim Investigational Site
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Coeur d'Alene, Idaho, United States
1184.14.01022 Boehringer Ingelheim Investigational Site
🇺🇸
Killeen, Texas, United States
1184.14.01008 Boehringer Ingelheim Investigational Site
🇺🇸
Spartanburg, South Carolina, United States
1184.14.01012 Boehringer Ingelheim Investigational Site
🇺🇸
East Providence, Rhode Island, United States
1184.14.01010 Boehringer Ingelheim Investigational Site
🇺🇸
Temple, Texas, United States
1184.14.01017 Boehringer Ingelheim Investigational Site
🇺🇸
Greenville, South Carolina, United States
1184.14.32001 Boehringer Ingelheim Investigational Site
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Brussel, Belgium
1184.14.02003 Boehringer Ingelheim Investigational Site
🇨🇦
Chilliwack, British Columbia, Canada
1184.14.01019 Boehringer Ingelheim Investigational Site
🇺🇸
Richmond, Virginia, United States
1184.14.02005 Boehringer Ingelheim Investigational Site
🇨🇦
Calgary, Alberta, Canada
1184.14.01011 Boehringer Ingelheim Investigational Site
🇺🇸
Richmond, Virginia, United States
1184.14.02002 Boehringer Ingelheim Investigational Site
🇨🇦
La Malbaie, Quebec, Canada
1184.14.45002 Boehringer Ingelheim Investigational Site
🇩🇰
København NV, Denmark
1184.14.35802 Boehringer Ingelheim Investigational Site
🇫🇮
Espoo, Finland
1184.14.35801 Boehringer Ingelheim Investigational Site
🇫🇮
HUS, Finland
1184.14.49004 Boehringer Ingelheim Investigational Site
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Berlin, Germany
1184.14.49006 Boehringer Ingelheim Investigational Site
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Berlin, Germany
1184.14.3303C Boehringer Ingelheim Investigational Site
🇫🇷
Perpignan, France
1184.14.3303A Boehringer Ingelheim Investigational Site
🇫🇷
Perpignan, France
1184.14.30004 Boehringer Ingelheim Investigational Site
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Nafplio, Greece
1184.14.36002 Boehringer Ingelheim Investigational Site
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Debrecen, Hungary
1184.14.3303B Boehringer Ingelheim Investigational Site
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Perpignan, France
1184.14.49002 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
1184.14.49001 Boehringer Ingelheim Investigational Site
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Leipzig, Germany
1184.14.36004 Boehringer Ingelheim Investigational Site
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Miskolc, Hungary
1184.14.46001 Boehringer Ingelheim Investigational Site
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Lund, Sweden
1184.14.02008 Boehringer Ingelheim Investigational Site
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Ste-Foy, Quebec, Canada
1184.14.02001 Boehringer Ingelheim Investigational Site
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Niagara Falls, Ontario, Canada
1184.14.3304A Boehringer Ingelheim Investigational Site
🇫🇷
Marseille, France
1184.14.01013 Boehringer Ingelheim Investigational Site
🇺🇸
Boulder, Colorado, United States
1184.14.01018 Boehringer Ingelheim Investigational Site
🇺🇸
Wheat Ridge, Colorado, United States
1184.14.01020 Boehringer Ingelheim Investigational Site
🇺🇸
Edina, Minnesota, United States
1184.14.01002 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, United States
1184.14.01009 Boehringer Ingelheim Investigational Site
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Burlington, North Carolina, United States
1184.14.01021 Boehringer Ingelheim Investigational Site
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Toledo, Ohio, United States
1184.14.01014 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
1184.14.32004 Boehringer Ingelheim Investigational Site
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Turnhout, Belgium
1184.14.02010 Boehringer Ingelheim Investigational Site
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Vancouver, British Columbia, Canada
1184.14.45001 Boehringer Ingelheim Investigational Site
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Hvidovre, Denmark
1184.14.02007 Boehringer Ingelheim Investigational Site
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Saskatoon, Saskatchewan, Canada
1184.14.3301A Boehringer Ingelheim Investigational Site
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Brest, France
1184.14.3302A Boehringer Ingelheim Investigational Site
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Montpellier, France
1184.14.49003 Boehringer Ingelheim Investigational Site
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Berlin, Germany
1184.14.49007 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
1184.14.30001 Boehringer Ingelheim Investigational Site
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Athens, Greece
1184.14.82002 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
1184.14.82001 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
1184.14.39001 Boehringer Ingelheim Investigational Site
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Pisa, Italy
1184.14.31003 Boehringer Ingelheim Investigational Site
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Heerlen, Netherlands
1184.14.31004 Boehringer Ingelheim Investigational Site
🇳🇱
Eindhoven, Netherlands
1184.14.31002 Boehringer Ingelheim Investigational Site
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Nieuwegein, Netherlands
1184.14.42103 Boehringer Ingelheim Investigational Site
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Bardejov, Slovakia
1184.14.46002 Boehringer Ingelheim Investigational Site
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Linköping, Sweden
1184.14.46003 Boehringer Ingelheim Investigational Site
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Sundsvall, Sweden
1184.14.49008 Boehringer Ingelheim Investigational Site
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Berlin, Germany
1184.14.01007 Boehringer Ingelheim Investigational Site
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Lafayette, Louisiana, United States
1184.14.82003 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
1184.14.01005 Boehringer Ingelheim Investigational Site
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Bangor, Maine, United States