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

Asthma Clinical Trial

Official title:

Randomised, Double-Blind, Placebo-Controlled, 5-Way Cross-Over Study to Assess the Efficacy (Bronchoprotection) and Safety of a Single Dose of Orally Inhaled BI 1744 CL (2, 5, 10 and 20ug) in Patients With Intermittent Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928668
• Other study ID #: 1222.4
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2009
• Last updated: May 29, 2014
• Start date: January 2006

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Diagnosis of intermittent asthma according to Global Initiative for Asthma criteria

2. 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

3. Forced Expiratory Volume in 1second greater than or equal to 80% predicted normal (Visit 1).

4. 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).

5. Be able to perform technically acceptable pulmonary function tests

6. Be able to inhale medication in a competent manner from the Respimat® inhaler

7. 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.

Exclusion criteria

1. Patients with a significant disease other than asthma

2. Patients with seasonal asthma or allergies whose participation in the trial will occur during the season for which they are allergic.

3. 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

4. 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.

5. Patients who have undergone thoracotomy with pulmonary resection

6. 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.

7. 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).

8. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1).

9. Pregnant or nursing women, or women of childbearing potential not using a highly effective method of birth control.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Placebo
Placebo device for comparison
• Olodaterol (BI1744CL)
Olodaterol comparison of low, medium low, medium high and high doses
• Olodaterol (BI1744CL)
Olodaterol comparison of low, medium low, medium high and high doses
• Olodaterol (BI1744CL)
Olodaterol comparison of low, medium low, medium high and high doses
• Olodaterol (BI1744CL)
Olodaterol comparison of low, medium low, medium high and high doses

Locations

Country	Name	City	State
Canada	1222.4.104 Department of Medicine, Health Sciences Centre	Hamilton	Ontario
Canada	1222.4.101 2725 Chemin Ste Foy	Sainte-Foy	Quebec
Canada	1222.4.102	Saskatoon	Saskatchewan
Canada	1222.4.103 UBC - Respiratory Medicine	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes	Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes	30 minutes post dose	No
Secondary	Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours	Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours	4 hours post dose	No
Secondary	Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours	Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours	8 hours post dose	No
Secondary	Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours	Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours	32 hours post dose	No
Secondary	Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG	Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).	5 days	No
Secondary	Laboratory Testing: Average Change From Baseline of Potassium and Calcium	Laboratory testing: Average change from baseline of potassium and calcium measured on test-days	Baseline to Visit 6	No

External Links

•   Link