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

Asthma Clinical Trial

Official title:

A Randomized, Double-blind Study to Compare the Safety and Efficacy of Berodual® Inhaled Via the Respimat® Device in Two Dosages (50 µg Fenoterol Hydrobromide + 20 µg Ipratropium Bromide and 25 µg Fenoterol Hydrobromide + 10 µg Ipratropium Bromide, 1 Puff t.i.d.) With That of Berodual® Inhaled Via the MDI With Aerochamber® (50 µg Fenoterol Hydrobromide + 21 µg Ipratropium Bromide, 2 Puffs t.i.d.) in Pediatric Patients With Asthma Over a 4 Week Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182505
• Other study ID #: 215.1105
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2014
• Last updated: July 11, 2014
• Start date: September 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesSouth Africa: Department of Health
• Study type: Interventional

Clinical Trial 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 t.i.d.) administered via Respimat® device 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 t.i.d.) administered via the MDI (chlorofluorocarbon-metered dose inhaler) with Aerochamber® and that the safety profile is at least as good when paediatric asthma patients are treated for four weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. primary completion date: July 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• Diagnosis of bronchial asthma according to the ATS (American Thoracic Society) criteria

• Male or female children between 6 and 15 years old

• Screening FEV1: 60-90 % of predicted normal. Predicted normal values will be based on the reference values by Cotes

• Airway obstruction reversibility: FEV1 should increase = 12% over baseline 30 to 60 minutes after administration of 2 puffs from the Berodual® MDI used with the Aerochamber®

• Ability to be trained in proper use of MDI with Aerochamber® and Respimat®

• 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

• Parent(s)/legal guardian is able and willing to give written informed consent in accordance with Good Clinical Practice (GCP) and local legislation. The child is willing to give oral consent

Exclusion Criteria:

• Patients with significant disease other than asthma, e.g. history of clinically significant cardiovascular, renal, neurological, hepatic or endocrine dysfunction (e.g. hyperthyreosis). 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

• Tuberculosis with indication for treatment

• History of cancer within the last five years

• Patients who have undergone thoracotomy

• Current psychiatric disorders

• History of life threatening pulmonary obstruction, active bronchiectasis, lung fibrosis, AIDS (acquired immunity deficiency syndrome) and cystic fibrosis

• Severe bronchial asthma with frequent nocturnal asthma attacks or acute exacerbations induced by recurrent bronchial infections several times per year

• 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 known narrow-angle glaucoma or raised intra-ocular pressure

• Patients with known intolerance or hypersensitivity to any of the trial medication including excipients

• Patients using oral corticosteroid medication within the last 4 weeks

• Patients using leukotriene receptor antagonists and 5-LO (lipoxygenase) inhibitors within the last 4 weeks

• Beta-blocker medication

• Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the screening visit

• Previous participation in the run-in phase of this study

• Presence of psycho-social factors in the patient and/or relatives which, at the discretion of the investigator, do not assure compliance with medication, procedures and/or protocol

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Berodual® Respimat®, low dose

• Berodual® Respimat®, high dose

• Berodual® MDI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average FEV1 AUC0-1 (FEV1( (Forced expiratory volume in one second) AUC0-1(Area under the curve between 0 and 1 hour ))		pre-dose and 5, 30, 60 minutes post-dose on day 29	No
Secondary	Average FEV1 between 0 and 1 hour (FEV1 AUC0-1)		pre-dose and 5, 30, 60 minutes post-dose on days 1 and 15	No
Secondary	Total average FEV1 between 0 and 1 hour (FEV1 AUC0-1)		pre-dose and 5, 30, 60 minutes post-dose on day 29	No
Secondary	FVC (Forced vital capacity)		pre-dose and 5, 30, 60 minutes post-dose on days 1, 15 and 29	No
Secondary	FEV25-75% (mean forced expiratory flow during the middle half of the FVC		pre-dose and 5, 30, 60 minutes post-dose on days 1, 15 and 29	No
Secondary	FEV1max		pre-dose and 5, 30, 60 minutes post-dose on days 1 and 29	No
Secondary	Onset of therapeutic response		Days 1 and 29	No
Secondary	Peak expiratory flow (PEF)		pre-dose until day 29	No
Secondary	Extent of use of rescue bronchodilator medication		up to day 29	No
Secondary	Overall incidence of adverse events		up to day 29	No
Secondary	Occurrence of application induced bronchoconstriction		up to day 29	No
Secondary	Number of patients with clinically significant changes in heart rate		pre-dose and 5, 30, 60 minutes post-dose on days 1, 15, 29	No
Secondary	Number of patients with clinically significant changes in blood pressure		pre-dose and 5, 30, 60 minutes post-dose on days 1, 15, 29	No
Secondary	Number of patients with abnormal findings in physical examination		Baseline, day 29	No

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