Clinical trial NCT00668772: Tiotropium/Salmeterol Inhalation Powder in 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: 2008-04-29
Enrollment: 207
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 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


Eligibility 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 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

Primary outcomes:
measure: Trough FEV1 response
timeFrame: 12 Weeks, 24 Weeks and 48 Weeks
measure: FEV1AUC 0 8hr response
timeFrame: 12 Weeks, 24 Weeks and 48 Weeks
measure: Mahler TDI focal score
timeFrame: 12 Weeks, 24 Weeks and 48 Weeks
measure: 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: Trough FEV1 response
timeFrame: 4, 36 and 48 weeks
measure: FEV1 AUC0-8h 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: Weekly mean number of COPD related night time awakenings
timeFrame: 1 week
measure: FVC (forced vital capacity) AUC0-8h and trough FVC response
timeFrame: 48 weeks
measure: Individual FEV1, FVC and PEF measurements
timeFrame: 48 weeks
measure: Weekly mean morning pre-dose and evening pre-dose PEFs (peak expiratory flow) and FEV1 (recorded by AM2+); PEFs determined by spirometry ]
timeFrame: 48 weeks
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: Anniston
country: United States
facility: 1184.15.01069 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 1184.15.01071 Boehringer Ingelheim Investigational Site
state: Alabama
city: Clearwater
country: United States
facility: 1184.15.01054 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1184.15.01063 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1184.15.01064 Boehringer Ingelheim Investigational Site
state: Florida
city: Savannah
country: United States
facility: 1184.15.01065 Boehringer Ingelheim Investigational Site
state: Georgia
city: New Orleans
country: United States
facility: 1184.15.01052 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Saint Louis
country: United States
facility: 1184.15.01055 Boehringer Ingelheim Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: 1184.15.01058 Boehringer Ingelheim Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: 1184.15.01062 Boehringer Ingelheim Investigational Site
state: Missouri
city: Summit
country: United States
facility: 1184.15.01072 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: 1184.15.01053 Boehringer Ingelheim Investigational Site
state: New Mexico
city: New York
country: United States
facility: 1184.15.01070 Boehringer Ingelheim Investigational Site
state: New York
city: Elizabeth City
country: United States
facility: 1184.15.01057 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charleston
country: United States
facility: 1184.15.01059 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Morgantown
country: United States
facility: 1184.15.01051 Boehringer Ingelheim Investigational Site
state: West Virginia
city: Gänserndorf
country: Austria
facility: 1184.15.43052 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1184.15.43053 Boehringer Ingelheim Investigational Site
city: Vancouver
country: Canada
facility: 1184.15.02057 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 1184.15.02059 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Hamilton
country: Canada
facility: 1184.15.02055 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1184.15.02058 Boehringer Ingelheim Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: 1184.15.02051 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1184.15.02053 Boehringer Ingelheim Investigational Site
state: Ontario
city: Longueuil
country: Canada
facility: 1184.15.02060 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1184.15.02056 Boehringer Ingelheim Investigational Site
state: Quebec
city: Aalborg
country: Denmark
facility: 1184.15.45054 Boehringer Ingelheim Investigational Site
city: Kolding
country: Denmark
facility: 1184.15.45052 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 1184.15.45051 Boehringer Ingelheim Investigational Site
city: Silkeborg
country: Denmark
facility: 1184.15.45053 Boehringer Ingelheim Investigational Site
city: Kohtla-Jarve
country: Estonia
facility: 1184.15.37252 Boehringer Ingelheim Investigational Site
city: Tallin
country: Estonia
facility: 1184.15.37251 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 1184.15.35852 Boehringer Ingelheim Investigational Site
city: Tampere
country: Finland
facility: 1184.15.35851 Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1184.15.3350A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1184.15.3351A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1184.15.3352A Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1184.15.49056 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1184.15.49053 Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: 1184.15.49057 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1184.15.49052 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1184.15.49058 Boehringer Ingelheim Investigational Site
city: Deszk
country: Hungary
facility: 1184.15.36055 Boehringer Ingelheim Investigational Site
city: Erd
country: Hungary
facility: 1184.15.36053 Boehringer Ingelheim Investigational Site
city: Szarvas
country: Hungary
facility: 1184.15.36054 Boehringer Ingelheim Investigational Site
city: Szeged
country: Hungary
facility: 1184.15.36052 Boehringer Ingelheim Investigational Site
city: Firenze
country: Italy
facility: 1184.15.39051 Boehringer Ingelheim Investigational Site
city: Jeonju
country: Korea, Republic of
facility: 1184.15.82051 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1184.15.82052 Boehringer Ingelheim Investigational Site
city: Wonju
country: Korea, Republic of
facility: 1184.15.82053 Boehringer Ingelheim Investigational Site
city: Balvi
country: Latvia
facility: 1184.15.37154 Boehringer Ingelheim Investigational Site
city: Jelgava
country: Latvia
facility: 1184.15.37152 Boehringer Ingelheim Investigational Site
city: Tukums
country: Latvia
facility: 1184.15.37153 Boehringer Ingelheim Investigational Site
city: Klaipeda
country: Lithuania
facility: 1184.15.37053 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1184.15.31051 Boehringer Ingelheim Investigational Site
city: Utrecht
country: Netherlands
facility: 1184.15.31054 Boehringer Ingelheim Investigational Site
city: Zutphen
country: Netherlands
facility: 1184.15.31052 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1184.15.42153 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1184.15.42154 Boehringer Ingelheim Investigational Site
city: Bellville
country: South Africa
facility: 1184.15.27051
city: Cape Town
country: South Africa
facility: 1184.15.27052
city: Somerset West
country: South Africa
facility: 1184.15.27053
city: Boden
country: Sweden
facility: 1184.15.46053 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1184.15.46051 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: