12 / 48 wk Pivotal PFT vs PBO in COPD II

NCT00782509 | Completed Phase 3 Results

• 2 other identifiers: 1222.122008-003704-67
• Study Type: interventional
• Target: 644
• Locations: 4 countries
• Sites: 51

Brief Summary

This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)

  Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.

  1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85

• Trough FEV1 Response at Day 85 (12 Weeks)

  Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.

  1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.

Secondary Outcomes (57)

• Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)

  1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)

• Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response At Day 1

  1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1

• Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks

  1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks

• Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks

  1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks

• Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks

  1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks

Study Arms (3)

Olodaterol (BI1744) Low

EXPERIMENTAL

Low dose inhaled orally once daily from the Respimat inhaler

Drug: Olodaterol (BI 1744)

Placebo

PLACEBO COMPARATOR

Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler

Drug: Placebo

Olodaterol (BI 1744) High

EXPERIMENTAL

High dose inhaled orally once daily from the Respimat inhaler

Drug: Olodaterol (BI 1744)

Interventions

Olodaterol (BI 1744) DRUG

Comparison of low and high doses on efficacy and safety in COPD patients

Olodaterol (BI 1744) High

Placebo DRUG

Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have a diagnosis of chronic obstructive pulmonary disease
• Male or female patients, 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1 \<80% predicted and post-bronchodilator FEV1/FVC \<70%

You may not qualify if:

• Patients with a significant disease other than COPD
• Patients with a history of asthma
• Patients with any of the following conditions:
• a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the past year. known active tuberculosis a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (51)

1222.12.1227 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1222.12.1218 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1222.12.1226 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

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1222.12.1214 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Location

1222.12.1207 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

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1222.12.1224 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Location

1222.12.1222 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

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1222.12.1208 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Location

1222.12.1220 Boehringer Ingelheim Investigational Site

River Forest, Illinois, United States

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1222.12.1229 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

1222.12.1219 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

1222.12.1209 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Location

1222.12.1233 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

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1222.12.1228 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

Location

1222.12.1206 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1222.12.1205 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

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1222.12.1213 Boehringer Ingelheim Investigational Site

Elizabeth City, North Carolina, United States

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1222.12.1223 Boehringer Ingelheim Investigational Site

Harrisburg, North Carolina, United States

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1222.12.1217 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1222.12.1203 Boehringer Ingelheim Investigational Site

Cincinnatti, Ohio, United States

Location

1222.12.1201 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1222.12.1230 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

1222.12.1216 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1222.12.1221 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1222.12.1212 Boehringer Ingelheim Investigational Site

Danville, Virginia, United States

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1222.12.1211 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1222.12.1225 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1222.12.1232 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Location

1222.12.1298 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1222.12.1301 Boehringer Ingelheim Investigational Site

Chongqing, China

Location

1222.12.1305 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1222.12.1306 Boehringer Ingelheim Investigational Site

Haikou, China

Location

1222.12.1302 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1222.12.1304 Boehringer Ingelheim Investigational Site

Nanjing, China

Location

1222.12.1296 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1222.12.1297 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1222.12.1303 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

1222.12.1299 Boehringer Ingelheim Investigational Site

Xi'an, China

Location

1222.12.1300 Boehringer Ingelheim Investigational Site

Xi'an, China

Location

1222.12.1269 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.12.1270 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.12.1271 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.12.1268 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1222.12.1266 Boehringer Ingelheim Investigational Site

Koblenz, Germany

Location

1222.12.1272 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1222.12.1267 Boehringer Ingelheim Investigational Site

Rüdersdorf, Germany

Location

1222.12.1290 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1222.12.1289 Boehringer Ingelheim Investigational Site

Kaohsiung County, Taiwan

Location

1222.12.1288 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1222.12.1287 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1222.12.1286 Boehringer Ingelheim Investigational Site

Taoyuan District, Taiwan

Location

Related Publications (4)

• Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

  PMID: 32943047 DERIVED

• Andreas S, Bothner U, de la Hoz A, Kloer I, Trampisch M, Alter P. A Post Hoc Holter ECG Analysis of Olodaterol and Formoterol in Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1955-1965. doi: 10.2147/COPD.S246353. eCollection 2020.

  PMID: 32848381 DERIVED

• Andreas S, Bothner U, Trampisch M, Haensel M, Buhl R, Alter P. Effect of long-acting beta2-agonists olodaterol and formoterol on heart rate and blood pressure in chronic obstructive pulmonary disease patients. Pulm Pharmacol Ther. 2018 Oct;52:1-6. doi: 10.1016/j.pupt.2018.08.002. Epub 2018 Aug 2.

  PMID: 30077810 DERIVED

• Ferguson GT, Feldman GJ, Hofbauer P, Hamilton A, Allen L, Korducki L, Sachs P. Efficacy and safety of olodaterol once daily delivered via Respimat(R) in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014 Jun 16;9:629-45. doi: 10.2147/COPD.S61717. eCollection 2014.

  PMID: 24966672 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: February 1, 2009
• Primary Completion: September 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: June 17, 2014

Record last verified: 2014-06

Locations

CN (11); US (28); TW (5); DE (7)