--- title: Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD) nct_id: NCT00662740 overall_status: TERMINATED phase: PHASE3 sponsor: Boehringer Ingelheim study_type: INTERVENTIONAL primary_condition: Pulmonary Disease, Chronic Obstructive countries: United States, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Slovakia, South Korea, Sweden canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00662740.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00662740" ct_last_update_post_date: 2023-08-23 last_seen_at: "2026-05-12T06:02:41.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD) **Official Title:** 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule) **NCT ID:** [NCT00662740](https://clinicaltrials.gov/study/NCT00662740) ## Key Facts - **Status:** TERMINATED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 220 - **Lead Sponsor:** Boehringer Ingelheim - **Conditions:** Pulmonary Disease, Chronic Obstructive - **Start Date:** 2008-04-15 - **Completion Date:** 2008-11-21 - **CT.gov Last Update:** 2023-08-23 ## Brief Summary The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations. ## Eligibility - **Minimum age:** 40 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Main Inclusion criteria: * Diagnosis of COPD * Post-bronchodilator FEV1\<80% predicted and FEV1/FVC\<70% predicted Main Exclusion criteria: * Significant other diseases then COPD * Recent myocardial infarction (MI) * Unstable or life-threatening arrythmia requiring intervention or change in drug therapy * Hospitalisation for cardiac failure in past year * History of asthma ``` ## Arms - **Tiotropium/Salmeterol quaque die (QD, once daily)** (EXPERIMENTAL) — Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule - **Tiotropium quaque die (QD, once daily)** (ACTIVE_COMPARATOR) — Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®) - **Salmeterol bis in die (BID, twice daily)** (ACTIVE_COMPARATOR) — Salmeterol Inhalation Powder, hard PE capsule - **Tiotropium/Salmeterol quaque die (QD, once daily)+ Salmeterol** (ACTIVE_COMPARATOR) — Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule - **Placebo** (PLACEBO_COMPARATOR) — Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule ## Interventions - **Tiotropium/Salmeterol QD** (DRUG) — Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule - **Placebo** (DRUG) — Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule - **Salmeterol** (DRUG) — Salmeterol Inhalation Powder, hard PE capsule - **Tiotropium/Salmeterol QD+ Salmeterol** (DRUG) — Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule - **Tiotropium (Spiriva®)** (DRUG) — Tiotropium, Spiriva® ## Primary Outcomes - **Trough forced expiratory volume in one second (FEV1) response** _(time frame: 12 Weeks, 24 Weeks and 48 Weeks)_ - **FEV1 area under the curve (AUC) 0-8h response** _(time frame: 12 Weeks, 24 Weeks and 48 Weeks)_ - **Mahler Transition Dyspnoea Index (TDI) focal score** _(time frame: 12 Weeks, 24 Weeks and 48 Weeks)_ - **St George Respiratory Questionnaire (SGRQ) total score** _(time frame: 12 Weeks, 24 Weeks and 48 Weeks)_ - **Time to first moderate to severe COPD exacerbation** _(time frame: 12 Weeks, 24 Weeks and 48 Weeks)_ ## Secondary Outcomes - **FEV1 AUC 0-8h response** _(time frame: 4, 36 and 48 weeks)_ - **Trough FEV1 response** _(time frame: 4, 36 and 48 weeks)_ - **Peak FEV1 response** _(time frame: 12, 24, 36 and 48 weeks)_ - **Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)** _(time frame: 24 hours)_ - **Forced vital capacity (FVC) AUC0-8h and trough FVC response** _(time frame: 48 weeks)_ - **Individual FEV1, FVC and peak expiratory flow (PEF) measurements** _(time frame: 48 weeks)_ - **Weekly mean morning pre-dose and evening pre-dose PEFs and FEV1 (recorded by Asthma Monitor® 2 (AM2+)); PEFs determined by spirometry ]** _(time frame: 48 weeks)_ - **Weekly mean number of COPD related night time awakenings** _(time frame: 1 week)_ - **Mahler TDI focal score** _(time frame: 4, 36 and 48 weeks)_ - **Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)** _(time frame: 4, 12, 24, 36 and 48 weeks)_ - **SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ** _(time frame: 4, 12, 36 and 48 weeks)_ - **All adverse events** _(time frame: 48 weeks)_ - **Vital signs: pulse rate and blood pressure** _(time frame: Baseline and 4 weeks)_ - **Routine blood chemistry, haematology and urinalysis** _(time frame: Baseline and 48 weeks)_ - **Vital status of randomised patients** _(time frame: 48 weeks)_ - **Number of days in hospital (including ambulance transportation** _(time frame: 48 weeks)_ - **Number of unscheduled health care provider visits** _(time frame: 48 weeks)_ - **Number of visits in emergency room (including ambulance transportation)** _(time frame: 48 weeks)_ - **Number of days in intensive care unit** _(time frame: 48 weeks)_ - **Concomitant medications (for instance antibiotics and systemic steroids).** _(time frame: 48 weeks)_ ## Locations (72) - 1184.14.01013 Boehringer Ingelheim Investigational Site, Boulder, Colorado, United States - 1184.14.01018 Boehringer Ingelheim Investigational Site, Wheat Ridge, Colorado, United States - 1184.14.01006 Boehringer Ingelheim Investigational Site, Winter Park, Florida, United States - 1184.14.01003 Boehringer Ingelheim Investigational Site, Coeur d'Alene, Idaho, United States - 1184.14.01015 Boehringer Ingelheim Investigational Site, South Bend, Indiana, United States - 1184.14.01007 Boehringer Ingelheim Investigational Site, Lafayette, Louisiana, United States - 1184.14.01005 Boehringer Ingelheim Investigational Site, Bangor, Maine, United States - 1184.14.01020 Boehringer Ingelheim Investigational Site, Edina, Minnesota, United States - 1184.14.01009 Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States - 1184.14.01002 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States - 1184.14.01021 Boehringer Ingelheim Investigational Site, Toledo, Ohio, United States - 1184.14.01012 Boehringer Ingelheim Investigational Site, East Providence, Rhode Island, United States - 1184.14.01017 Boehringer Ingelheim Investigational Site, Greenville, South Carolina, United States - 1184.14.01008 Boehringer Ingelheim Investigational Site, Spartanburg, South Carolina, United States - 1184.14.01014 Boehringer Ingelheim Investigational Site, Houston, Texas, United States - 1184.14.01022 Boehringer Ingelheim Investigational Site, Killeen, Texas, United States - 1184.14.01001 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States - 1184.14.01010 Boehringer Ingelheim Investigational Site, Temple, Texas, United States - 1184.14.01011 Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States - 1184.14.01019 Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States - 1184.14.43001 Boehringer Ingelheim Investigational Site, Feldbach, Austria - 1184.14.32001 Boehringer Ingelheim Investigational Site, Brussels, Belgium - 1184.14.32004 Boehringer Ingelheim Investigational Site, Turnhout, Belgium - 1184.14.02005 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada - 1184.14.02003 Boehringer Ingelheim Investigational Site, Chilliwack, British Columbia, Canada - 1184.14.02010 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada - 1184.14.02001 Boehringer Ingelheim Investigational Site, Niagara Falls, Ontario, Canada - 1184.14.02002 Boehringer Ingelheim Investigational Site, La Malbaie, Quebec, Canada - 1184.14.02008 Boehringer Ingelheim Investigational Site, Ste-Foy, Quebec, Canada - 1184.14.02007 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada - 1184.14.45001 Boehringer Ingelheim Investigational Site, Hvidovre, Denmark - 1184.14.45002 Boehringer Ingelheim Investigational Site, København NV, Denmark - 1184.14.37202 Boehringer Ingelheim Investigational Site, Tallinn, Estonia - 1184.14.37201 Boehringer Ingelheim Investigational Site, Tartu, Estonia - 1184.14.35802 Boehringer Ingelheim Investigational Site, Espoo, Finland - 1184.14.35801 Boehringer Ingelheim Investigational Site, HUS, Finland - 1184.14.3301A Boehringer Ingelheim Investigational Site, Brest, France - 1184.14.3304A Boehringer Ingelheim Investigational Site, Marseille, France - 1184.14.3302A Boehringer Ingelheim Investigational Site, Montpellier, France - 1184.14.3303A Boehringer Ingelheim Investigational Site, Perpignan, France - 1184.14.3303B Boehringer Ingelheim Investigational Site, Perpignan, France - 1184.14.3303C Boehringer Ingelheim Investigational Site, Perpignan, France - 1184.14.49003 Boehringer Ingelheim Investigational Site, Berlin, Germany - 1184.14.49004 Boehringer Ingelheim Investigational Site, Berlin, Germany - 1184.14.49006 Boehringer Ingelheim Investigational Site, Berlin, Germany - 1184.14.49008 Boehringer Ingelheim Investigational Site, Berlin, Germany - 1184.14.49002 Boehringer Ingelheim Investigational Site, Hamburg, Germany - 1184.14.49007 Boehringer Ingelheim Investigational Site, Hamburg, Germany - 1184.14.49001 Boehringer Ingelheim Investigational Site, Leipzig, Germany - 1184.14.30001 Boehringer Ingelheim Investigational Site, Athens, Greece - 1184.14.30004 Boehringer Ingelheim Investigational Site, Nafplion, Greece - 1184.14.30006 Boehringer Ingelheim Investigational Site, Rethymno, Greece - 1184.14.36002 Boehringer Ingelheim Investigational Site, Debrecen, Hungary - 1184.14.36001 Boehringer Ingelheim Investigational Site, Hodmezövasarhely, Hungary - 1184.14.36005 Boehringer Ingelheim Investigational Site, Komló, Hungary - 1184.14.36004 Boehringer Ingelheim Investigational Site, Miskolc, Hungary - 1184.14.39001 Boehringer Ingelheim Investigational Site, Pisa, Italy - 1184.14.37101 Boehringer Ingelheim Investigational Site, Krāslava, Latvia - 1184.14.37103 Boehringer Ingelheim Investigational Site, Kuldīga, Latvia - 1184.14.37102 Boehringer Ingelheim Investigational Site, Talsi, Latvia - 1184.14.37003 Boehringer Ingelheim Investigational Site, Klaipėda, Lithuania - 1184.14.31004 Boehringer Ingelheim Investigational Site, Eindhoven, Netherlands - 1184.14.31003 Boehringer Ingelheim Investigational Site, Heerlen, Netherlands - 1184.14.31002 Boehringer Ingelheim Investigational Site, Nieuwegein, Netherlands - 1184.14.31001 Boehringer Ingelheim Investigational Site, Veldhoven, Netherlands - 1184.14.42103 Boehringer Ingelheim Investigational Site, Bardejov, Slovakia - 1184.14.82001 Boehringer Ingelheim Investigational Site, Seoul, South Korea - 1184.14.82002 Boehringer Ingelheim Investigational Site, Seoul, South Korea - 1184.14.82003 Boehringer Ingelheim Investigational Site, Seoul, South Korea - 1184.14.46002 Boehringer Ingelheim Investigational Site, Linköping, Sweden - 1184.14.46001 Boehringer Ingelheim Investigational Site, Lund, Sweden - 1184.14.46003 Boehringer Ingelheim Investigational Site, Sundsvall, Sweden ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — 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.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.1184.14.01013 boehringer ingelheim investigational site|boulder|colorado|united states` — added _(2026-05-12)_ - `locations.1184.14.01018 boehringer ingelheim investigational site|wheat ridge|colorado|united states` — added _(2026-05-12)_ - `locations.1184.14.01006 boehringer ingelheim investigational site|winter park|florida|united states` — added _(2026-05-12)_ - `locations.1184.14.01003 boehringer ingelheim investigational site|coeur d'alene|idaho|united states` — added _(2026-05-12)_ - `locations.1184.14.01015 boehringer ingelheim investigational site|south bend|indiana|united states` — added _(2026-05-12)_ - `locations.1184.14.01007 boehringer ingelheim investigational site|lafayette|louisiana|united states` — added _(2026-05-12)_ - `locations.1184.14.01005 boehringer ingelheim investigational site|bangor|maine|united states` — added _(2026-05-12)_ - `locations.1184.14.01020 boehringer ingelheim investigational site|edina|minnesota|united states` — added _(2026-05-12)_ - `locations.1184.14.01009 boehringer ingelheim investigational site|burlington|north carolina|united states` — added _(2026-05-12)_ - `locations.1184.14.01002 boehringer ingelheim investigational site|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.1184.14.01021 boehringer ingelheim investigational site|toledo|ohio|united states` — added _(2026-05-12)_ - `locations.1184.14.01012 boehringer ingelheim investigational site|east providence|rhode island|united states` — added _(2026-05-12)_ - `locations.1184.14.01017 boehringer ingelheim investigational site|greenville|south carolina|united states` — added _(2026-05-12)_ - `locations.1184.14.01008 boehringer ingelheim investigational site|spartanburg|south carolina|united states` — added _(2026-05-12)_ - `locations.1184.14.01014 boehringer ingelheim investigational site|houston|texas|united states` — added _(2026-05-12)_ - `locations.1184.14.01022 boehringer ingelheim investigational site|killeen|texas|united states` — added _(2026-05-12)_ - `locations.1184.14.01001 boehringer ingelheim investigational site|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.1184.14.01010 boehringer ingelheim investigational site|temple|texas|united states` — added _(2026-05-12)_ - `locations.1184.14.01011 boehringer ingelheim investigational site|richmond|virginia|united states` — added _(2026-05-12)_ - `locations.1184.14.01019 boehringer ingelheim investigational site|richmond|virginia|united states` — added _(2026-05-12)_ - `locations.1184.14.43001 boehringer ingelheim investigational site|feldbach||austria` — added _(2026-05-12)_ - `locations.1184.14.32001 boehringer ingelheim investigational site|brussels||belgium` — added _(2026-05-12)_ - `locations.1184.14.32004 boehringer ingelheim investigational site|turnhout||belgium` — added _(2026-05-12)_ - `locations.1184.14.02005 boehringer ingelheim investigational site|calgary|alberta|canada` — added _(2026-05-12)_ - `locations.1184.14.02003 boehringer ingelheim investigational site|chilliwack|british columbia|canada` — added _(2026-05-12)_ - `locations.1184.14.02010 boehringer ingelheim investigational site|vancouver|british columbia|canada` — added _(2026-05-12)_ - `locations.1184.14.02001 boehringer ingelheim investigational site|niagara falls|ontario|canada` — added _(2026-05-12)_ - `locations.1184.14.02002 boehringer ingelheim investigational site|la malbaie|quebec|canada` — added _(2026-05-12)_ - `locations.1184.14.02008 boehringer ingelheim investigational site|ste-foy|quebec|canada` — added _(2026-05-12)_ - `locations.1184.14.02007 boehringer ingelheim investigational site|saskatoon|saskatchewan|canada` — added _(2026-05-12)_ - `locations.1184.14.45001 boehringer ingelheim investigational site|hvidovre||denmark` — added _(2026-05-12)_ - `locations.1184.14.45002 boehringer ingelheim investigational site|københavn nv||denmark` — added _(2026-05-12)_ - `locations.1184.14.37202 boehringer ingelheim investigational site|tallinn||estonia` — added _(2026-05-12)_ - `locations.1184.14.37201 boehringer ingelheim investigational site|tartu||estonia` — added _(2026-05-12)_ - `locations.1184.14.35802 boehringer ingelheim investigational site|espoo||finland` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00662740.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00662740* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*