Safety and Efficacy of Berodual® Respimat® Compared to Berodual® MDI (Metered Dose Inhaler) in Asthma Patients

NCT02182479 | Completed Phase 3

• 1 other identifier: 215.1104
• Study Type: interventional
• Target: 631
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium bromide, 1 puff q.i.d.) administered via Respimat® gives a bronchodilator response which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg ipratropium bromide, 2 puffs q.i.d.) administered via MDI and that the safety profile is at least as good in asthma patients treated for 12 weeks.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change in average FEV1 (Forced expiratory volume in one second) (AUC0-6 (Area under the curve))

  Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85

Secondary Outcomes (12)

• FEV1max

  Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85

• Time to onset of therapeutic response

  Days 1, 29, 57 and 85

• Duration of therapeutic response

  Days 1, 29, 57 and 85

• Time to peak FEV1

  Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85

• Change in averaged weekly morning and evening pre-dose PEFR (peak expiratory flow rate)

  up to day 85

Study Arms (5)

Berodual® via Respimat®, high dose

EXPERIMENTAL

Drug: Berodual® via Respimat®, high dose

Berodual® via Respimat®, low dose

EXPERIMENTAL

Drug: Berodual® via Respimat®, low dose

Berodual® via MDI, high dose

ACTIVE COMPARATOR

Drug: Berodual® via MDI, high dose

Placebo via Respimat®

PLACEBO COMPARATOR

Drug: Placebo Respimat®

Placebo via MDI

PLACEBO COMPARATOR

Drug: Placebo MDI

Interventions

Berodual® via Respimat®, high dose DRUG

Berodual® via Respimat®, high dose

Berodual® via Respimat®, low dose DRUG

Berodual® via Respimat®, low dose

Berodual® via MDI, high dose DRUG

Berodual® via MDI, high dose

Placebo Respimat® DRUG

Placebo via Respimat®

Placebo MDI DRUG

Placebo via MDI

Eligibility Criteria

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

You may qualify if:

• Diagnosis of bronchial asthma according to the ATS (American Thoracic Society)
• Age: 18 - 65 years
• Screening FEV1: 40 - 80 % of predicted normal. Predicted normal values will be based on the guidelines for standardised function testing of the European Community for Coal and Steel
• Airway obstruction reversibility: increase in FEV1 12% from baseline and ≥ 200 ml from baseline at 30 minutes after 2 puffs of Berodual® MDI
• Current non-smoker or ex-smoker (with a smoking history of ≤ 10 pack-years) with cessation of smoking ≥ 1 year prior to the screening visit
• Male or female patients
• Ability to be trained in proper use of MDI and RESPIMAT® devices
• Ability to perform technically satisfactory pulmonary function tests
• No hospital admission for an exacerbation and stable dosage of all pulmonary medication in the last four weeks (except for long acting β2 agonists)
• Willingness and ability to sign informed consent form prior to participation in the trial

You may not qualify if:

• Patients with significant disease other than asthma, e.g. history of clinically significant cardiovascular, renal, neurological, hepatic or endocrine dysfunction. A clinically significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or which may influence the results of the study or the ability of the patient to participate in and complete the study
• History of myocardial infarction within the last year
• Tuberculosis with indication for treatment
• History of cancer within the last five years, excluding treated basal cell carcinoma
• Patients who have undergone thoracotomy for pulmonary resection of more than one bullae, or with subsequent impaired thoracic muscle performance leading to unsatisfactory lung function testing
• Current psychiatric disorders
• History of life threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
• An upper or lower respiratory tract infection in the four weeks prior to the screening visit (= Visit 1) or during the 2-week run-in period
• Patients with AST/ALT (aspartate amino transferase/alanine amino transferase) (SGOT/SGPT (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase)) \> 200%, bilirubin \> 150% (except isolated bilirubin increase due to Gilbert's Syndrome), or creatinine \> 125% of the upper limit of the normal range
• Intolerance to aerosolised fenoterol- or ipratropium-containing products, and/or hypersensitivity to any of the MDI ingredients
• Patients using oral corticosteroid medication at unstable (i.e. less than 4 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day
• Beta-blocker medication
• Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the screening visit
• History of drug abuse and/or alcoholism
• Pregnant or nursing women and women of childbearing potential or less than 2 years postmenopausal, who are not using medically approved means of contraception (oral contraceptives, intra-uterine devices or surgical Sterilisation)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 1998
• Primary Completion: June 1, 1999
• Last Updated: July 14, 2014

Record last verified: 2014-07