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Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol PE Capsule) in COPD

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Tiotropium/Salmeterol QD (Drug); Placebo (Drug); Salmeterol (Drug); Tiotropium/Salmeterol QD+ Salmeterol (Drug); Tiotropium (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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 by the SGRQ and the effect on COPD exacerbations.

Clinical Details

Official title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Trough FEV1 response

FEV1AUC 0 8h response

Mahler TDI focal score

SGRQ total score

Time to first moderate to severe COPD exacerbation

Secondary outcome:

FEV1 AUC0-8h response

Trough FEV1 response

Peak FEV1 response

Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)

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 ]

Weekly mean number of COPD related night time awakenings

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).

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

1184.14.43001 Boehringer Ingelheim Investigational Site, Feldbach, Austria

1184.14.32001 Boehringer Ingelheim Investigational Site, Brussel, Belgium

1184.14.32004 Boehringer Ingelheim Investigational Site, Turnhout, Belgium

1184.14.45001 Boehringer Ingelheim Investigational Site, Hvidovre, Denmark

1184.14.45002 Boehringer Ingelheim Investigational Site, København NV, Denmark

1184.14.37202 Boehringer Ingelheim Investigational Site, Tallin, Estonia

1184.14.37201 Boehringer Ingelheim Investigational Site, Tartu, Estonia

1184.14.35802 Boehringer Ingelheim Investigational Site, Espoo, Finland

1184.14.35801 Boehringer Ingelheim Investigational Site, HUS, Finland

1184.14.3301A Boehringer Ingelheim Investigational Site, Brest, France

1184.14.3304A Boehringer Ingelheim Investigational Site, Marseille, France

1184.14.3302A Boehringer Ingelheim Investigational Site, Montpellier, 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, Perpignan, France

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, Berlin, Germany

1184.14.49002 Boehringer Ingelheim Investigational Site, Hamburg, Germany

1184.14.49007 Boehringer Ingelheim Investigational Site, Hamburg, Germany

1184.14.49001 Boehringer Ingelheim Investigational Site, Leipzig, Germany

1184.14.30001 Boehringer Ingelheim Investigational Site, Athens, Greece

1184.14.30004 Boehringer Ingelheim Investigational Site, Nafplio, Greece

1184.14.30006 Boehringer Ingelheim Investigational Site, Rethymno, Greece

1184.14.36002 Boehringer Ingelheim Investigational Site, Debrecen, Hungary

1184.14.36001 Boehringer Ingelheim Investigational Site, Hodmezövasarhely, Hungary

1184.14.36005 Boehringer Ingelheim Investigational Site, Komlo, Hungary

1184.14.36004 Boehringer Ingelheim Investigational Site, Miskolc, Hungary

1184.14.39001 Boehringer Ingelheim Investigational Site, Pisa, Italy

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, Seoul, Korea, Republic of

1184.14.37101 Boehringer Ingelheim Investigational Site, Kraslava, Latvia

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

1184.14.31004 Boehringer Ingelheim Investigational Site, Eindhoven, Netherlands

1184.14.31003 Boehringer Ingelheim Investigational Site, Heerlen, Netherlands

1184.14.31002 Boehringer Ingelheim Investigational Site, Nieuwegein, Netherlands

1184.14.31001 Boehringer Ingelheim Investigational Site, Veldhoven, Netherlands

1184.14.42103 Boehringer Ingelheim Investigational Site, Bardejov, Slovakia

1184.14.46002 Boehringer Ingelheim Investigational Site, Linköping, Sweden

1184.14.46001 Boehringer Ingelheim Investigational Site, Lund, Sweden

1184.14.46003 Boehringer Ingelheim Investigational Site, Sundsvall, Sweden

1184.14.02005 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada

1184.14.02003 Boehringer Ingelheim Investigational Site, Chilliwack, British Columbia, Canada

1184.14.02010 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada

1184.14.01013 Boehringer Ingelheim Investigational Site, Boulder, Colorado, United States

1184.14.01018 Boehringer Ingelheim Investigational Site, Wheat Ridge, Colorado, United States

1184.14.01006 Boehringer Ingelheim Investigational Site, Winter Park, Florida, United States

1184.14.01003 Boehringer Ingelheim Investigational Site, Coeur D'Alene, Idaho, United States

1184.14.01015 Boehringer Ingelheim Investigational Site, South Bend, Indiana, United States

1184.14.01007 Boehringer Ingelheim Investigational Site, Lafayette, Louisiana, United States

1184.14.01005 Boehringer Ingelheim Investigational Site, Bangor, Maine, United States

1184.14.01020 Boehringer Ingelheim Investigational Site, Edina, Minnesota, United States

1184.14.01009 Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States

1184.14.01002 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States

1184.14.01021 Boehringer Ingelheim Investigational Site, Toledo, Ohio, United States

1184.14.02001 Boehringer Ingelheim Investigational Site, Niagara Falls, Ontario, Canada

1184.14.02002 Boehringer Ingelheim Investigational Site, La Malbaie, Quebec, Canada

1184.14.02008 Boehringer Ingelheim Investigational Site, Ste-Foy, Quebec, Canada

1184.14.01012 Boehringer Ingelheim Investigational Site, East Providence, Rhode Island, United States

1184.14.02007 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada

1184.14.01017 Boehringer Ingelheim Investigational Site, Greenville, South Carolina, United States

1184.14.01008 Boehringer Ingelheim Investigational Site, Spartanburg, South Carolina, United States

1184.14.01014 Boehringer Ingelheim Investigational Site, Houston, Texas, United States

1184.14.01022 Boehringer Ingelheim Investigational Site, Killeen, Texas, United States

1184.14.01001 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States

1184.14.01010 Boehringer Ingelheim Investigational Site, Temple, Texas, United States

1184.14.01011 Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States

1184.14.01019 Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States

Additional Information

Starting date: April 2008
Last updated: April 30, 2014

Page last updated: August 23, 2015

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