Clinical trial NCT00662740: Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)
Official title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 220
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Main Inclusion criteria:

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

Main Exclusion criteria:

* Significant other diseases then COPD
* Recent myocardial infarction (MI)
* Unstable or life-threatening arrythmia requiring intervention or change in drug therapy
* Hospitalisation for cardiac failure in past year
* History of asthma

Primary outcomes:
measure: Trough forced expiratory volume in one second (FEV1) response
timeFrame: 12 Weeks, 24 Weeks and 48 Weeks
measure: FEV1 area under the curve (AUC) 0-8h response
timeFrame: 12 Weeks, 24 Weeks and 48 Weeks
measure: Mahler Transition Dyspnoea Index (TDI) focal score
timeFrame: 12 Weeks, 24 Weeks and 48 Weeks
measure: St George Respiratory Questionnaire (SGRQ) total score
timeFrame: 12 Weeks, 24 Weeks and 48 Weeks
measure: Time to first moderate to severe COPD exacerbation
timeFrame: 12 Weeks, 24 Weeks and 48 Weeks
Secondary outcomes:
measure: FEV1 AUC 0-8h response
timeFrame: 4, 36 and 48 weeks
measure: Trough FEV1 response
timeFrame: 4, 36 and 48 weeks
measure: Peak FEV1 response
timeFrame: 12, 24, 36 and 48 weeks
measure: Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)
timeFrame: 24 hours
measure: Forced vital capacity (FVC) AUC0-8h and trough FVC response
timeFrame: 48 weeks
measure: Individual FEV1, FVC and peak expiratory flow (PEF) measurements
timeFrame: 48 weeks
measure: Weekly mean morning pre-dose and evening pre-dose PEFs and FEV1 (recorded by Asthma Monitor® 2 (AM2+)); PEFs determined by spirometry ]
timeFrame: 48 weeks
measure: Weekly mean number of COPD related night time awakenings
timeFrame: 1 week
measure: Mahler TDI focal score
timeFrame: 4, 36 and 48 weeks
measure: Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)
timeFrame: 4, 12, 24, 36 and 48 weeks
measure: SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ
timeFrame: 4, 12, 36 and 48 weeks
measure: All adverse events
timeFrame: 48 weeks
measure: Vital signs: pulse rate and blood pressure
timeFrame: Baseline and 4 weeks
measure: Routine blood chemistry, haematology and urinalysis
timeFrame: Baseline and 48 weeks
measure: Vital status of randomised patients
timeFrame: 48 weeks
measure: Number of days in hospital (including ambulance transportation
timeFrame: 48 weeks
measure: Number of unscheduled health care provider visits
timeFrame: 48 weeks
measure: Number of visits in emergency room (including ambulance transportation)
timeFrame: 48 weeks
measure: Number of days in intensive care unit
timeFrame: 48 weeks
measure: Concomitant medications (for instance antibiotics and systemic steroids).
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: 1184.14.01013 Boehringer Ingelheim Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: 1184.14.01018 Boehringer Ingelheim Investigational Site
state: Colorado
city: Winter Park
country: United States
facility: 1184.14.01006 Boehringer Ingelheim Investigational Site
state: Florida
city: Coeur d'Alene
country: United States
facility: 1184.14.01003 Boehringer Ingelheim Investigational Site
state: Idaho
city: South Bend
country: United States
facility: 1184.14.01015 Boehringer Ingelheim Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: 1184.14.01007 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Bangor
country: United States
facility: 1184.14.01005 Boehringer Ingelheim Investigational Site
state: Maine
city: Edina
country: United States
facility: 1184.14.01020 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Burlington
country: United States
facility: 1184.14.01009 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 1184.14.01002 Boehringer Ingelheim Investigational Site
state: Ohio
city: Toledo
country: United States
facility: 1184.14.01021 Boehringer Ingelheim Investigational Site
state: Ohio
city: East Providence
country: United States
facility: 1184.14.01012 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Greenville
country: United States
facility: 1184.14.01017 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 1184.14.01008 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Houston
country: United States
facility: 1184.14.01014 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 1184.14.01022 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1184.14.01001 Boehringer Ingelheim Investigational Site
state: Texas
city: Temple
country: United States
facility: 1184.14.01010 Boehringer Ingelheim Investigational Site
state: Texas
city: Richmond
country: United States
facility: 1184.14.01011 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 1184.14.01019 Boehringer Ingelheim Investigational Site
state: Virginia
city: Feldbach
country: Austria
facility: 1184.14.43001 Boehringer Ingelheim Investigational Site
city: Brussel
country: Belgium
facility: 1184.14.32001 Boehringer Ingelheim Investigational Site
city: Turnhout
country: Belgium
facility: 1184.14.32004 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1184.14.02005 Boehringer Ingelheim Investigational Site
state: Alberta
city: Chilliwack
country: Canada
facility: 1184.14.02003 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 1184.14.02010 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Niagara Falls
country: Canada
facility: 1184.14.02001 Boehringer Ingelheim Investigational Site
state: Ontario
city: La Malbaie
country: Canada
facility: 1184.14.02002 Boehringer Ingelheim Investigational Site
state: Quebec
city: Ste-Foy
country: Canada
facility: 1184.14.02008 Boehringer Ingelheim Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: 1184.14.02007 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Hvidovre
country: Denmark
facility: 1184.14.45001 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1184.14.45002 Boehringer Ingelheim Investigational Site
city: Tallin
country: Estonia
facility: 1184.14.37202 Boehringer Ingelheim Investigational Site
city: Tartu
country: Estonia
facility: 1184.14.37201 Boehringer Ingelheim Investigational Site
city: Espoo
country: Finland
facility: 1184.14.35802 Boehringer Ingelheim Investigational Site
city: HUS
country: Finland
facility: 1184.14.35801 Boehringer Ingelheim Investigational Site
city: Brest
country: France
facility: 1184.14.3301A Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1184.14.3304A Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 1184.14.3302A Boehringer Ingelheim Investigational Site
city: Perpignan
country: France
facility: 1184.14.3303A Boehringer Ingelheim Investigational Site
city: Perpignan
country: France
facility: 1184.14.3303B Boehringer Ingelheim Investigational Site
city: Perpignan
country: France
facility: 1184.14.3303C Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1184.14.49003 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1184.14.49004 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1184.14.49006 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1184.14.49008 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1184.14.49002 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1184.14.49007 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1184.14.49001 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1184.14.30001 Boehringer Ingelheim Investigational Site
city: Nafplio
country: Greece
facility: 1184.14.30004 Boehringer Ingelheim Investigational Site
city: Rethymno
country: Greece
facility: 1184.14.30006 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1184.14.36002 Boehringer Ingelheim Investigational Site
city: Hodmezövasarhely
country: Hungary
facility: 1184.14.36001 Boehringer Ingelheim Investigational Site
city: Komlo
country: Hungary
facility: 1184.14.36005 Boehringer Ingelheim Investigational Site
city: Miskolc
country: Hungary
facility: 1184.14.36004 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1184.14.39001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1184.14.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1184.14.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1184.14.82003 Boehringer Ingelheim Investigational Site
city: Kraslava
country: Latvia
facility: 1184.14.37101 Boehringer Ingelheim Investigational Site
city: Kuldiga
country: Latvia
facility: 1184.14.37103 Boehringer Ingelheim Investigational Site
city: Talsi
country: Latvia
facility: 1184.14.37102 Boehringer Ingelheim Investigational Site
city: Klaipeda
country: Lithuania
facility: 1184.14.37003 Boehringer Ingelheim Investigational Site
city: Eindhoven
country: Netherlands
facility: 1184.14.31004 Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: 1184.14.31003 Boehringer Ingelheim Investigational Site
city: Nieuwegein
country: Netherlands
facility: 1184.14.31002 Boehringer Ingelheim Investigational Site
city: Veldhoven
country: Netherlands
facility: 1184.14.31001 Boehringer Ingelheim Investigational Site
city: Bardejov
country: Slovakia
facility: 1184.14.42103 Boehringer Ingelheim Investigational Site
city: Linköping
country: Sweden
facility: 1184.14.46002 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1184.14.46001 Boehringer Ingelheim Investigational Site
city: Sundsvall
country: Sweden
facility: 1184.14.46003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: