Tiotropium/Salmeterol Inhalation Powder in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00668772
• Other study ID #: 1184.15
• Secondary ID: 2007-005107-17
• Status: Terminated
• Phase: Phase 3
• Start date: April 15, 2008
• Est. completion date: November 21, 2008

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 207
• Est. completion date: November 21, 2008
• Est. primary completion date: November 21, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium/Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
• Tiotropium/Salmeterol QD + Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
• Placebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
• Salmeterol
Salmeterol Inhalation Powder, hard PE capsule
• Tiotropium
Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Locations

Country	Name	City	State
Austria	1184.15.43052 Boehringer Ingelheim Investigational Site	Gänserndorf
Austria	1184.15.43053 Boehringer Ingelheim Investigational Site	Wien
Canada	1184.15.02055 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1184.15.02060 Boehringer Ingelheim Investigational Site	Longueuil	Quebec
Canada	1184.15.02056 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1184.15.02058 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	1184.15.02051 Boehringer Ingelheim Investigational Site	Scarborough	Ontario
Canada	1184.15.02053 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1184.15.02057 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1184.15.02059 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Denmark	1184.15.45054 Boehringer Ingelheim Investigational Site	Aalborg
Denmark	1184.15.45052 Boehringer Ingelheim Investigational Site	Kolding
Denmark	1184.15.45051 Boehringer Ingelheim Investigational Site	Odense C
Denmark	1184.15.45053 Boehringer Ingelheim Investigational Site	Silkeborg
Estonia	1184.15.37252 Boehringer Ingelheim Investigational Site	Kohtla-Jarve
Estonia	1184.15.37251 Boehringer Ingelheim Investigational Site	Tallin
Finland	1184.15.35852 Boehringer Ingelheim Investigational Site	Oulu
Finland	1184.15.35851 Boehringer Ingelheim Investigational Site	Tampere
France	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
Germany	1184.15.49056 Boehringer Ingelheim Investigational Site	Aschaffenburg
Germany	1184.15.49053 Boehringer Ingelheim Investigational Site	Frankfurt
Germany	1184.15.49057 Boehringer Ingelheim Investigational Site	Gelnhausen
Germany	1184.15.49052 Boehringer Ingelheim Investigational Site	Hannover
Germany	1184.15.49058 Boehringer Ingelheim Investigational Site	Hannover
Hungary	1184.15.36055 Boehringer Ingelheim Investigational Site	Deszk
Hungary	1184.15.36053 Boehringer Ingelheim Investigational Site	Erd
Hungary	1184.15.36054 Boehringer Ingelheim Investigational Site	Szarvas
Hungary	1184.15.36052 Boehringer Ingelheim Investigational Site	Szeged
Italy	1184.15.39051 Boehringer Ingelheim Investigational Site	Firenze
Korea, Republic of	1184.15.82051 Boehringer Ingelheim Investigational Site	Jeonju
Korea, Republic of	1184.15.82052 Boehringer Ingelheim Investigational Site	Suwon
Korea, Republic of	1184.15.82053 Boehringer Ingelheim Investigational Site	Wonju
Latvia	1184.15.37154 Boehringer Ingelheim Investigational Site	Balvi
Latvia	1184.15.37152 Boehringer Ingelheim Investigational Site	Jelgava
Latvia	1184.15.37153 Boehringer Ingelheim Investigational Site	Tukums
Lithuania	1184.15.37053 Boehringer Ingelheim Investigational Site	Klaipeda
Netherlands	1184.15.31051 Boehringer Ingelheim Investigational Site	Breda
Netherlands	1184.15.31054 Boehringer Ingelheim Investigational Site	Utrecht
Netherlands	1184.15.31052 Boehringer Ingelheim Investigational Site	Zutphen
Slovakia	1184.15.42153 Boehringer Ingelheim Investigational Site	Bratislava
Slovakia	1184.15.42154 Boehringer Ingelheim Investigational Site	Bratislava
South Africa	1184.15.27051	Bellville
South Africa	1184.15.27052	Cape Town
South Africa	1184.15.27053	Somerset West
Sweden	1184.15.46053 Boehringer Ingelheim Investigational Site	Boden
Sweden	1184.15.46051 Boehringer Ingelheim Investigational Site	Stockholm
United States	1184.15.01053 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	1184.15.01069 Boehringer Ingelheim Investigational Site	Anniston	Alabama
United States	1184.15.01059 Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	1184.15.01054 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	1184.15.01057 Boehringer Ingelheim Investigational Site	Elizabeth City	North Carolina
United States	1184.15.01071 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	1184.15.01051 Boehringer Ingelheim Investigational Site	Morgantown	West Virginia
United States	1184.15.01052 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana
United States	1184.15.01070 Boehringer Ingelheim Investigational Site	New York	New York
United States	1184.15.01055 Boehringer Ingelheim Investigational Site	Saint Louis	Missouri
United States	1184.15.01058 Boehringer Ingelheim Investigational Site	Saint Louis	Missouri
United States	1184.15.01062 Boehringer Ingelheim Investigational Site	Saint Louis	Missouri
United States	1184.15.01065 Boehringer Ingelheim Investigational Site	Savannah	Georgia
United States	1184.15.01072 Boehringer Ingelheim Investigational Site	Summit	New Jersey
United States	1184.15.01063 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	1184.15.01064 Boehringer Ingelheim Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  Estonia,  Finland,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Netherlands,  Slovakia,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough FEV1 response		12 Weeks, 24 Weeks and 48 Weeks
Primary	FEV1AUC 0 8hr response		12 Weeks, 24 Weeks and 48 Weeks
Primary	Mahler TDI focal score		12 Weeks, 24 Weeks and 48 Weeks
Primary	SGRQ total score		12 Weeks, 24 Weeks and 48 Weeks
Primary	Time to first moderate to severe COPD exacerbation		12 Weeks, 24 Weeks and 48 Weeks
Secondary	Trough FEV1 response		4, 36 and 48 weeks
Secondary	FEV1 AUC0-8h response		4, 36 and 48 weeks
Secondary	Peak FEV1 response		12, 24, 36 and 48 weeks
Secondary	Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)		24 hours
Secondary	Weekly mean number of COPD related night time awakenings		1 week
Secondary	FVC (forced vital capacity) AUC0-8h and trough FVC response		48 weeks
Secondary	Individual FEV1, FVC and PEF measurements		48 weeks
Secondary	Weekly mean morning pre-dose and evening pre-dose PEFs (peak expiratory flow) and FEV1 (recorded by AM2+); PEFs determined by spirometry ]		48 weeks
Secondary	Mahler TDI focal score		4, 36 and 48 weeks
Secondary	Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)		4, 12, 24, 36 and 48 weeks
Secondary	SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ		4, 12, 36 and 48 weeks
Secondary	All adverse events		48 weeks
Secondary	Vital signs: pulse rate and blood pressure		Baseline and 4 weeks
Secondary	Routine blood chemistry, haematology and urinalysis		Baseline and 48 weeks
Secondary	Vital status of randomised patients		48 weeks
Secondary	Number of days in hospital (including ambulance transportation		48 weeks
Secondary	Number of unscheduled health care provider visits		48 weeks
Secondary	Number of visits in emergency room (including ambulance transportation)		48 weeks
Secondary	Number of days in intensive care unit		48 weeks
Secondary	Concomitant medications (for instance antibiotics and systemic steroids)		48 weeks

External Links

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