12 / 48 Week Pivotal PFT vs PBO in COPD I

NCT00782210 | Completed Phase 3 Results

• 2 other identifiers: 1222.112008-003647-36
• Study Type: interventional
• Target: 625
• Locations: 6 countries
• Sites: 54

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). The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.

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 (BI 1744) Low

EXPERIMENTAL

Low dose inhaled orally once daily from the Respimat inhaler

Drug: Olodaterol (BI1744)

Olodaterol (BI 1744) High

EXPERIMENTAL

High dose inhaled orally once daily from the Respimat inhaler

Drug: Olodaterol (BI1744)

Placebo

PLACEBO COMPARATOR

Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler

Drug: placebo

Interventions

Olodaterol (BI1744) DRUG

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

Olodaterol (BI 1744) Low

placebo DRUG

Olodaterol (BI1744) 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 (54)

1222.11.1122 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Location

1222.11.1116 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

1222.11.1121 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1222.11.1111 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Location

1222.11.1117 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Location

1222.11.1110 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1222.11.1106 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

1222.11.1108 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

1222.11.1109 Boehringer Ingelheim Investigational Site

Bowling Green, Kentucky, United States

Location

1222.11.1113 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1222.11.1115 Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

Location

1222.11.1120 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Location

1222.11.1105 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1222.11.1112 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1222.11.1119 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1222.11.1102 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Location

1222.11.1124 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1222.11.1101 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1222.11.1103 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1222.11.1114 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1222.11.1123 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1222.11.1143 Boehringer Ingelheim Investigational Site

Concord, New South Wales, Australia

Location

1222.11.1145 Boehringer Ingelheim Investigational Site

Glebe, New South Wales, Australia

Location

1222.11.1144 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Location

1222.11.1142 Boehringer Ingelheim Investigational Site

Toorak Gardens, South Australia, Australia

Location

1222.11.1141 Boehringer Ingelheim Investigational Site

Woodville, South Australia, Australia

Location

1222.11.1166 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1222.11.1171 Boehringer Ingelheim Investigational Site

Changsha, China

Location

1222.11.1170 Boehringer Ingelheim Investigational Site

Chengdu, China

Location

1222.11.1169 Boehringer Ingelheim Investigational Site

Chongqing, China

Location

1222.11.1172 Boehringer Ingelheim Investigational Site

Dalian, China

Location

1222.11.1163 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1222.11.1167 Boehringer Ingelheim Investigational Site

Nanjing, China

Location

1222.11.1164 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1222.11.1165 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1222.11.1173 Boehringer Ingelheim Investigational Site

Shenyang, China

Location

1222.11.1168 Boehringer Ingelheim Investigational Site

Xi'an, China

Location

1222.11.1151 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.11.1156 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.11.1157 Boehringer Ingelheim Investigational Site

Erfurt, Germany

Location

1222.11.1154 Boehringer Ingelheim Investigational Site

Halle, Germany

Location

1222.11.1153 Boehringer Ingelheim Investigational Site

Kassel, Germany

Location

1222.11.1158 Boehringer Ingelheim Investigational Site

Oschersleben, Germany

Location

1222.11.1152 Boehringer Ingelheim Investigational Site

Potsdam, Germany

Location

1222.11.1155 Boehringer Ingelheim Investigational Site

Weinheim, Germany

Location

1222.11.1138 Boehringer Ingelheim Investigational Site

Hamilton, New Zealand

Location

1222.11.1139 Boehringer Ingelheim Investigational Site

Otahuhu, New Zealand

Location

1222.11.1136 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand

Location

1222.11.1137 Boehringer Ingelheim Investigational Site

Wellington, New Zealand

Location

1222.11.1180 Boehringer Ingelheim Investigational Site

Changhua, Taiwan

Location

1222.11.1181 Boehringer Ingelheim Investigational Site

Chiayi City, Taiwan

Location

1222.11.1179 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1222.11.1177 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1222.11.1178 Boehringer Ingelheim Investigational Site

Taipei, 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: November 1, 2008
• Primary Completion: September 1, 2010
• Last Updated: June 9, 2014
• Results First Posted: April 30, 2014

Record last verified: 2014-03

Locations

DE (8); TW (5); NZ (4); AU (5); CN (11); US (21)