NCT00388882|CompletedPhase 4

Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.

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

Boehringer Ingelheim ClinicalTrials.gov

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2 other identifiers

205.346EudraCT 2006-000822-30

Study Type

interventional

Target

327

Locations

5 countries

Sites

Timeline

RegisteredOct 2006

StartedOct 2006

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

327

participants targeted

Target at P75+ for phase_4

Geographic Reach

5 countries

40 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2006

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2007

Completed

Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

October 16, 2006

Last Update Submit

November 30, 2023

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

Trough FEV1
after 12 weeks of treatment
FEV1 AUC0-6 hours
after 12 weeks of treatment

Secondary Outcomes (15)

Peak FEV1
12 weeks
Peak FEV1
after first dose and 6 week
FEV1 AUC0-6 hours
after first dose and 6 weeks
Trough FEV1
at 6 weeks
Peak FVC at all clinic visits
12 weeks
+10 more secondary outcomes

Interventions

tiotropiumDRUG

ipratropium bromide / albuterolDRUG

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boehringer Ingelheimlead

Study Sites (40)

205.346.107 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

205.346.104 Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Location

205.346.108 Boehringer Ingelheim Investigational Site

Sepulveda, California, United States

Location

205.346.101 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Location

205.346.106 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

205.346.102 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

205.346.109 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

205.346.110 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

205.346.105 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

205.346.103 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

205.346.510

Bs As, Argentina

Location

205.346.502

Buenos Aires, Argentina

Location

205.346.503

Buenos Aires, Argentina

Location

205.346.508

Buenos Airess, Argentina

Location

205.346.505

Mendoza, Argentina

Location

205.346.509

Rosario, Santa Fe, Argentina

Location

205.346.511

Rosario, Santa Fé, Argentina

Location

205.346.504 Instituto de Patologías Respiratorias

San Miguel de Tucumán, Argentina

Location

205.346.401 Boehringer Ingelheim Investigational Site

Alytus, Lithuania

Location

205.346.404 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

205.346.405 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

205.346.411 Boehringer Ingelheim Investigational Site

Klaipėda, Lithuania

Location

205.346.409 Boehringer Ingelheim Investigational Site

Šiauliai, Lithuania

Location

205.346.408 Boehringer Ingelheim Investigational Site

Utena, Lithuania

Location

205.346.402 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

205.346.406 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

205.346.407 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

205.346.302 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

205.346.305 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

205.346.301 Boehringer Ingelheim Investigational Site

Košice, Slovakia

Location

205.346.303 Boehringer Ingelheim Investigational Site

Levica, Slovakia

Location

205.346.304 Boehringer Ingelheim Investigational Site

Lučenec, Slovakia

Location

205.346.306 Boehringer Ingelheim Investigational Site

Štúrovo, Slovakia

Location

205.346.204 Boehringer Ingelheim Investigational Site

Aylesbury, United Kingdom

Location

205.346.203 Boehringer Ingelheim Investigational Site

Greenisland, United Kingdom

Location

205.346.201 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

Location

205.346.207 Boehringer Ingelheim Investigational Site

Soham, United Kingdom

Location

205.346.209 Boehringer Ingelheim Investigational Site

Swansea, United Kingdom

Location

205.346.206 Boehringer Ingelheim Investigational Site

Westbury on Trym, United Kingdom

Location

205.346.205 Boehringer Ingelheim Investigational Site

Windsor, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium BromideIpratropiumAlbuterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingAtropine DerivativesBelladonna AlkaloidsSolanaceous AlkaloidsEthanolaminesAmino AlcoholsAlcoholsAminesPhenethylaminesEthylamines

Study Officials

Boehringer Ingelheim
Boehringer Ingelheim
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 4
Purpose: TREATMENT
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 17, 2006

Study Start

October 4, 2006

Primary Completion

October 8, 2007

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

GB(7)LI(9)AR(8)US(10)SL(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (15)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (40)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations