--- title: Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients. nct_id: NCT00388882 overall_status: COMPLETED phase: PHASE4 sponsor: Boehringer Ingelheim study_type: INTERVENTIONAL primary_condition: Pulmonary Disease, Chronic Obstructive countries: United States, Argentina, Lithuania, Slovakia, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00388882.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00388882" ct_last_update_post_date: 2023-12-01 last_seen_at: "2026-05-12T06:11:01.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT00388882](https://clinicaltrials.gov/study/NCT00388882) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 327 - **Lead Sponsor:** Boehringer Ingelheim - **Conditions:** Pulmonary Disease, Chronic Obstructive - **Start Date:** 2006-10-04 - **CT.gov Last Update:** 2023-12-01 ## 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 - **Minimum age:** 40 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Interventions - **tiotropium** (DRUG) - **ipratropium bromide / albuterol** (DRUG) ## Primary Outcomes - **Trough FEV1** _(time frame: after 12 weeks of treatment)_ - **FEV1 AUC0-6 hours** _(time frame: after 12 weeks of treatment)_ ## Secondary Outcomes - **Peak FEV1** _(time frame: 12 weeks)_ - **Peak FEV1** _(time frame: after first dose and 6 week)_ - **FEV1 AUC0-6 hours** _(time frame: after first dose and 6 weeks)_ - **Trough FEV1** _(time frame: at 6 weeks)_ - **Peak FVC at all clinic visits** _(time frame: 12 weeks)_ - **AUC0-6 hours FVC at all clinic visits** _(time frame: 12 weeks)_ - **Trough FVC** _(time frame: at 6 and 12 weeks)_ - **Individual FEV1 measurements** _(time frame: 12 weeks)_ - **Individual FVC measurements** _(time frame: 12 weeks)_ - **Use of Albuterol (scheduled and rescue)** _(time frame: 12 weeks)_ - **Patient Global Evaluation** _(time frame: 12 weeks)_ - **Physician Global Evaluation** _(time frame: 12 weeks)_ - **PEFR (Peak expiratory flow rate) measured by the patient at home twice daily** _(time frame: 12 weeks)_ - **Occurrence of adverse events** _(time frame: 12 weeks)_ - **Vital Signs** _(time frame: 12 weeks)_ ## Locations (40) - 205.346.107 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States - 205.346.104 Boehringer Ingelheim Investigational Site, Lakewood, California, United States - 205.346.108 Boehringer Ingelheim Investigational Site, Sepulveda, California, United States - 205.346.101 Boehringer Ingelheim Investigational Site, Torrance, California, United States - 205.346.106 Boehringer Ingelheim Investigational Site, Wheat Ridge, Colorado, United States - 205.346.102 Boehringer Ingelheim Investigational Site, Coeur d'Alene, Idaho, United States - 205.346.109 Boehringer Ingelheim Investigational Site, Shreveport, Louisiana, United States - 205.346.110 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States - 205.346.105 Boehringer Ingelheim Investigational Site, Charleston, South Carolina, United States - 205.346.103 Boehringer Ingelheim Investigational Site, Spartanburg, South Carolina, United States - 205.346.510, Bs As, Argentina - 205.346.502, Buenos Aires, Argentina - 205.346.503, Buenos Aires, Argentina - 205.346.508, Buenos Airess, Argentina - 205.346.505, Mendoza, Argentina - 205.346.509, Rosario, Santa Fe, Argentina - 205.346.511, Rosario, Santa Fé, Argentina - 205.346.504 Instituto de Patologías Respiratorias, San Miguel de Tucumán, Argentina - 205.346.401 Boehringer Ingelheim Investigational Site, Alytus, Lithuania - 205.346.404 Boehringer Ingelheim Investigational Site, Kaunas, Lithuania - 205.346.405 Boehringer Ingelheim Investigational Site, Kaunas, Lithuania - 205.346.411 Boehringer Ingelheim Investigational Site, Klaipėda, Lithuania - 205.346.409 Boehringer Ingelheim Investigational Site, Šiauliai, Lithuania - 205.346.408 Boehringer Ingelheim Investigational Site, Utena, Lithuania - 205.346.402 Boehringer Ingelheim Investigational Site, Vilnius, Lithuania - 205.346.406 Boehringer Ingelheim Investigational Site, Vilnius, Lithuania - 205.346.407 Boehringer Ingelheim Investigational Site, Vilnius, Lithuania - 205.346.302 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia - 205.346.305 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia - 205.346.301 Boehringer Ingelheim Investigational Site, Košice, Slovakia - 205.346.303 Boehringer Ingelheim Investigational Site, Levica, Slovakia - 205.346.304 Boehringer Ingelheim Investigational Site, Lučenec, Slovakia - 205.346.306 Boehringer Ingelheim Investigational Site, Štúrovo, Slovakia - 205.346.204 Boehringer Ingelheim Investigational Site, Aylesbury, United Kingdom - 205.346.203 Boehringer Ingelheim Investigational Site, Greenisland, United Kingdom - 205.346.201 Boehringer Ingelheim Investigational Site, Nottingham, United Kingdom - 205.346.207 Boehringer Ingelheim Investigational Site, Soham, United Kingdom - 205.346.209 Boehringer Ingelheim Investigational Site, Swansea, United Kingdom - 205.346.206 Boehringer Ingelheim Investigational Site, Westbury on Trym, United Kingdom - 205.346.205 Boehringer Ingelheim Investigational Site, Windsor, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.205.346.106 boehringer ingelheim investigational site|wheat ridge|colorado|united states` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.205.346.107 boehringer ingelheim investigational site|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.205.346.104 boehringer ingelheim investigational site|lakewood|california|united states` — added _(2026-05-12)_ - `locations.205.346.108 boehringer ingelheim investigational site|sepulveda|california|united states` — added _(2026-05-12)_ - `locations.205.346.101 boehringer ingelheim investigational site|torrance|california|united states` — added _(2026-05-12)_ - `locations.205.346.102 boehringer ingelheim investigational site|coeur d'alene|idaho|united states` — added _(2026-05-12)_ - `locations.205.346.109 boehringer ingelheim investigational site|shreveport|louisiana|united states` — added _(2026-05-12)_ - `locations.205.346.110 boehringer ingelheim investigational site|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.205.346.105 boehringer ingelheim investigational site|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.205.346.103 boehringer ingelheim investigational site|spartanburg|south carolina|united states` — added _(2026-05-12)_ - `locations.205.346.510|bs as||argentina` — added _(2026-05-12)_ - `locations.205.346.502|buenos aires||argentina` — added _(2026-05-12)_ - `locations.205.346.503|buenos aires||argentina` — added _(2026-05-12)_ - `locations.205.346.508|buenos airess||argentina` — added _(2026-05-12)_ - `locations.205.346.505|mendoza||argentina` — added _(2026-05-12)_ - `locations.205.346.509|rosario, santa fe||argentina` — added _(2026-05-12)_ - `locations.205.346.511|rosario, santa fé||argentina` — added _(2026-05-12)_ - `locations.205.346.504 instituto de patologías respiratorias|san miguel de tucumán||argentina` — added _(2026-05-12)_ - `locations.205.346.401 boehringer ingelheim investigational site|alytus||lithuania` — added _(2026-05-12)_ - `locations.205.346.404 boehringer ingelheim investigational site|kaunas||lithuania` — added _(2026-05-12)_ - `locations.205.346.405 boehringer ingelheim investigational site|kaunas||lithuania` — added _(2026-05-12)_ - `locations.205.346.411 boehringer ingelheim investigational site|klaipėda||lithuania` — added _(2026-05-12)_ - `locations.205.346.409 boehringer ingelheim investigational site|šiauliai||lithuania` — added _(2026-05-12)_ - `locations.205.346.408 boehringer ingelheim investigational site|utena||lithuania` — added _(2026-05-12)_ - `locations.205.346.402 boehringer ingelheim investigational site|vilnius||lithuania` — added _(2026-05-12)_ - `locations.205.346.406 boehringer ingelheim investigational site|vilnius||lithuania` — added _(2026-05-12)_ - `locations.205.346.407 boehringer ingelheim investigational site|vilnius||lithuania` — added _(2026-05-12)_ - `locations.205.346.302 boehringer ingelheim investigational site|bratislava||slovakia` — added _(2026-05-12)_ - `locations.205.346.305 boehringer ingelheim investigational site|bratislava||slovakia` — added _(2026-05-12)_ - `locations.205.346.301 boehringer ingelheim investigational site|košice||slovakia` — added _(2026-05-12)_ - `locations.205.346.303 boehringer ingelheim investigational site|levica||slovakia` — added _(2026-05-12)_ - `locations.205.346.304 boehringer ingelheim investigational site|lučenec||slovakia` — added _(2026-05-12)_ - `locations.205.346.306 boehringer ingelheim investigational site|štúrovo||slovakia` — added _(2026-05-12)_ - `locations.205.346.204 boehringer ingelheim investigational site|aylesbury||united kingdom` — added _(2026-05-12)_ - `locations.205.346.203 boehringer ingelheim investigational site|greenisland||united kingdom` — added _(2026-05-12)_ - `locations.205.346.201 boehringer ingelheim investigational site|nottingham||united kingdom` — added _(2026-05-12)_ - `locations.205.346.207 boehringer ingelheim investigational site|soham||united kingdom` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00388882.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00388882* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*