Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease

NCT01809262 | Completed Phase 2 Results

• 1 other identifier: 1222.3
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment

  Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.

  24 hours post-dosing

Secondary Outcomes (11)

• FEV1 AUC 0 - 3 Hours

  -10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing

• FEV1 AUC 0 - 12 Hours

  -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing

• FEV1 AUC 0 - 24 Hours

  -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing

• FEV1 AUC 12 - 24 Hours

  12h, 14h, 22h, 23h and 24h post-dosing

• Peak FEV1 From 0 to 3 Hours

  0 to 3 hours post-dosing

Study Arms (6)

olodaterol 2 mcg

EXPERIMENTAL

solution for inhalation

Drug: single dose of 2 mcg

olodaterol 5 mcg

EXPERIMENTAL

solution for inhalation

Drug: single dose of 5 mcg

olodaterol 10 mcg

EXPERIMENTAL

solution for inhalation

Drug: single dose of 10 mcg

olodaterol 20 mcg

EXPERIMENTAL

solution for inhalation

Drug: single dose of 20 mcg

olodaterol 40 mcg

EXPERIMENTAL

solution for inhalation

Drug: single dose of 40 mcg

placebo

PLACEBO COMPARATOR

solution for inhalation

Drug: single dose of placebo

Interventions

single dose of 5 mcg DRUG

solution for inhalation

olodaterol 5 mcg

single dose of placebo DRUG

solution for inhalation

placebo

single dose of 40 mcg DRUG

solution for inhalation

olodaterol 40 mcg

single dose of 20 mcg DRUG

solution for inhalation

olodaterol 20 mcg

single dose of 2 mcg DRUG

solution for inhalation

olodaterol 2 mcg

single dose of 10 mcg DRUG

solution for inhalation

olodaterol 10 mcg

Eligibility Criteria

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

You may qualify if:

• Diagnosis of chronic obstructive pulmonary disease
• Smoking history of more than 10-pack years

You may not qualify if:

• History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias
• Marked baseline prolongation of QT/QTc interval

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1222.3.1 Atrium medisch centrum

Heerlen, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 12, 2013
• Study Start: December 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: June 30, 2014
• Results First Posted: June 30, 2014

Record last verified: 2014-05

Locations

NL (1)