Efficacy (Bronchoprotection) and Safety of Orally Inhaled BI 1744 CL in Patients With Intermittent Asthma

NCT00928668 | Completed Phase 2 Results

• 1 other identifier: 1222.4
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours

  Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours

  24 hours post dose

Secondary Outcomes (6)

• Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes

  30 minutes post dose

• Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours

  4 hours post dose

• Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours

  8 hours post dose

• Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours

  32 hours post dose

• Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG

  5 days

Study Arms (5)

Olodaterol (BI1744) Low

EXPERIMENTAL

Single dosing of low dose Olodaterol inhaled orally from Respimat Device

Drug: Olodaterol (BI1744CL)

Olodaterol (BI1744) Medium Low

EXPERIMENTAL

Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device

Drug: Olodaterol (BI1744CL)

Olodaterol (BI1744) Medium High

EXPERIMENTAL

Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device

Drug: Olodaterol (BI1744CL)

Olodaterol (BI 1744) High

EXPERIMENTAL

Single dosing of high dose Olodaterol inhaled orally from Respimat Device

Drug: Olodaterol (BI1744CL)

Placebo

PLACEBO COMPARATOR

Single dosing of Olodaterol placebo inhaled orally from Respimat Device

Drug: Placebo

Interventions

Placebo DRUG

Placebo device for comparison

Placebo

Olodaterol (BI1744CL) DRUG

Olodaterol comparison of low, medium low, medium high and high doses

Olodaterol (BI1744) Medium High

Eligibility Criteria

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

You may qualify if:

• Diagnosis of intermittent asthma according to Global Initiative for Asthma criteria
• Non-smokers or ex-smokers who have not smoked for at least 1 year and have a smoking history of less than 5 pack-years
• Forced Expiratory Volume in 1second greater than or equal to 80% predicted normal (Visit 1).
• Bronchial hyperresponsiveness to inhaled methacholine with a provocative concentration of a methacholine causing a 20% fall in Forced Expiratory Volume in one second less than or equal to 8 mg/mL (Visit 1).
• Be able to perform technically acceptable pulmonary function tests
• Be able to inhale medication in a competent manner from the Respimat® inhaler
• Must sign and date an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice guidelines prior to participation in the trial, which includes medication washout and restrictions.

You may not qualify if:

• Patients with a significant disease other than asthma
• Patients with seasonal asthma or allergies whose participation in the trial will occur during the season for which they are allergic.
• Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with a serum glutamic oxaloacetic transaminase \> 80 IU/L, serum glutamic pyruvic transaminase \> 80 IU/L, bilirubin \>2.0 mg/dL or creatinine \> 2.0 mg/dL will be excluded regardless of clinical condition
• Patients with any of the following conditions: a diagnosis of hyperthyrosis or paroxysmal tachycardia (\>100 beats per minute), a marked baseline prolongation of QT/QTc interval, a history of additional risk factors for Torsade de Pointes, a history of myocardial infarction, a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, or a history of significant alcohol or drug abuse.
• Patients who have undergone thoracotomy with pulmonary resection
• Patients who are being treated with any of the following concomitant medications: medications that prolong the QT/QTc interval, oral beta-adrenergics, beta-blockers or monoamine oxidase inhibitors or tricyclic antidepressants.
• Patients who have been treated with any respiratory medications (excluding short-acting beta-agonists) for control of their asthma symptoms within 3 months of the Screening Visit (Visit 1).
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1).
• Pregnant or nursing women, or women of childbearing potential not using a highly effective method of birth control.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

1222.4.103 UBC - Respiratory Medicine

Vancouver, British Columbia, Canada

Location

1222.4.104 Department of Medicine, Health Sciences Centre

Hamilton, Ontario, Canada

Location

1222.4.101 2725 Chemin Ste Foy

Sainte-Foy, Quebec, Canada

Location

1222.4.102

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

olodaterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: January 1, 2006
• Primary Completion: October 1, 2006
• Last Updated: July 1, 2014
• Results First Posted: July 1, 2014

Record last verified: 2014-05

Locations

CA (4)