Clinical trial NCT00388882: Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
Official title: A Randomized, Double-blind, Double-dummy, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium Inhalation Capsules 18 mcg Via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations q.i.d. in COPD Patients Currently Prescribed Combivent® Inhalation Aerosol CFC MDI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 327
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Age: \>= 40 years
* Current or ex-smoker with a \>= 10 pack-year smoking history
* Use of Combivent® MDI for \>= 1 month prior to Visit 1 Spirometric criteria (determined at study visits):
* Post-bronchodilator FEV1 \<= 70% (Visit 1)
* Pre-bronchodilator FEV1 \<= 65% of predicted and FEV1/FVC \<= 70% (Visit 2)

Exclusion Criteria:

* Clinical history of asthma
* History of thoracotomy with pulmonary resection
* History of CF, alpha 1 antitrypsin deficiency or interstitial lung disease
* Daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain from using oxygen during PFTs
* Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
* Recent history 6 months or less of MI
* Unstable or life-threatening cardiac arrhythmias
* Hospitalization for CHF during past year
* Malignancy for which patient is receiving chemo or radiation therapy
* Pregnant or nursing women
* Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose
* Use of SPIRIVA® 3 months prior to Visit 1
* Symptomatic of prostatic hypertrophy or bladder neck obstruction
* Known narrow- angle glaucoma
* Participating in a pulmonary rehab program within 4 weeks of Visit 1

Primary outcomes:
measure: Trough FEV1
timeFrame: after 12 weeks of treatment
measure: FEV1 AUC0-6 hours
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Peak FEV1
timeFrame: 12 weeks
measure: Peak FEV1
timeFrame: after first dose and 6 week
measure: FEV1 AUC0-6 hours
timeFrame: after first dose and 6 weeks
measure: Trough FEV1
timeFrame: at 6 weeks
measure: Peak FVC at all clinic visits
timeFrame: 12 weeks
measure: AUC0-6 hours FVC at all clinic visits
timeFrame: 12 weeks
measure: Trough FVC
timeFrame: at 6 and 12 weeks
measure: Individual FEV1 measurements
timeFrame: 12 weeks
measure: Individual FVC measurements
timeFrame: 12 weeks
measure: Use of Albuterol (scheduled and rescue)
timeFrame: 12 weeks
measure: Patient Global Evaluation
timeFrame: 12 weeks
measure: Physician Global Evaluation
timeFrame: 12 weeks
measure: PEFR (Peak expiratory flow rate) measured by the patient at home twice daily
timeFrame: 12 weeks
measure: Occurrence of adverse events
timeFrame: 12 weeks
measure: Vital Signs
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 205.346.107 Boehringer Ingelheim Investigational Site
state: Arizona
city: Lakewood
country: United States
facility: 205.346.104 Boehringer Ingelheim Investigational Site
state: California
city: Sepulveda
country: United States
facility: 205.346.108 Boehringer Ingelheim Investigational Site
state: California
city: Torrance
country: United States
facility: 205.346.101 Boehringer Ingelheim Investigational Site
state: California
city: Wheat Ridge
country: United States
facility: 205.346.106 Boehringer Ingelheim Investigational Site
state: Colorado
city: Coeur d'Alene
country: United States
facility: 205.346.102 Boehringer Ingelheim Investigational Site
state: Idaho
city: Shreveport
country: United States
facility: 205.346.109 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Philadelphia
country: United States
facility: 205.346.110 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: 205.346.105 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 205.346.103 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Bs As
country: Argentina
facility: 205.346.510
city: Buenos Airess
country: Argentina
facility: 205.346.508
city: Buenos Aires
country: Argentina
facility: 205.346.502
city: Buenos Aires
country: Argentina
facility: 205.346.503
city: Mendoza
country: Argentina
facility: 205.346.505
city: Rosario, Santa Fe
country: Argentina
facility: 205.346.509
city: Rosario, Santa Fé
country: Argentina
facility: 205.346.511
city: San Miguel de Tucumán
country: Argentina
facility: 205.346.504 Instituto de Patologías Respiratorias
city: Alytus
country: Lithuania
facility: 205.346.401 Boehringer Ingelheim Investigational Site
city: Kaunas
country: Lithuania
facility: 205.346.404 Boehringer Ingelheim Investigational Site
city: Kaunas
country: Lithuania
facility: 205.346.405 Boehringer Ingelheim Investigational Site
city: Klaipeda
country: Lithuania
facility: 205.346.411 Boehringer Ingelheim Investigational Site
city: Siauliai
country: Lithuania
facility: 205.346.409 Boehringer Ingelheim Investigational Site
city: Utena
country: Lithuania
facility: 205.346.408 Boehringer Ingelheim Investigational Site
city: Vilnius
country: Lithuania
facility: 205.346.402 Boehringer Ingelheim Investigational Site
city: Vilnius
country: Lithuania
facility: 205.346.406 Boehringer Ingelheim Investigational Site
city: Vilnius
country: Lithuania
facility: 205.346.407 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 205.346.302 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 205.346.305 Boehringer Ingelheim Investigational Site
city: Kosice
country: Slovakia
facility: 205.346.301 Boehringer Ingelheim Investigational Site
city: Levica
country: Slovakia
facility: 205.346.303 Boehringer Ingelheim Investigational Site
city: Lucenec
country: Slovakia
facility: 205.346.304 Boehringer Ingelheim Investigational Site
city: Sturovo
country: Slovakia
facility: 205.346.306 Boehringer Ingelheim Investigational Site
city: Aylesbury
country: United Kingdom
facility: 205.346.204 Boehringer Ingelheim Investigational Site
city: Greenisland
country: United Kingdom
facility: 205.346.203 Boehringer Ingelheim Investigational Site
city: Nottingham
country: United Kingdom
facility: 205.346.201 Boehringer Ingelheim Investigational Site
city: Soham
country: United Kingdom
facility: 205.346.207 Boehringer Ingelheim Investigational Site
city: Swansea
country: United Kingdom
facility: 205.346.209 Boehringer Ingelheim Investigational Site
city: Westbury On Trym
country: United Kingdom
facility: 205.346.206 Boehringer Ingelheim Investigational Site
city: Windsor
country: United Kingdom
facility: 205.346.205 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: