Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182505
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Berodual® Respimat®, low dose Drug: Berodual® Respimat®, high dose Drug: Berodual® MDI Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : September 1998
Actual Primary Completion Date : July 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Berodual® Respimat®, low dose Drug: Berodual® Respimat®, low dose
Experimental: Berodual® Respimat®, high dose Drug: Berodual® Respimat®, high dose
Active Comparator: Berodual® MDI Aerochamber® Drug: Berodual® MDI



Primary Outcome Measures :
  1. Change in average FEV1 AUC0-1 (FEV1( (Forced expiratory volume in one second) AUC0-1(Area under the curve between 0 and 1 hour )) [ Time Frame: pre-dose and 5, 30, 60 minutes post-dose on day 29 ]

Secondary Outcome Measures :
  1. Average FEV1 between 0 and 1 hour (FEV1 AUC0-1) [ Time Frame: pre-dose and 5, 30, 60 minutes post-dose on days 1 and 15 ]
  2. Total average FEV1 between 0 and 1 hour (FEV1 AUC0-1) [ Time Frame: pre-dose and 5, 30, 60 minutes post-dose on day 29 ]
  3. FVC (Forced vital capacity) [ Time Frame: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15 and 29 ]
  4. FEV25-75% (mean forced expiratory flow during the middle half of the FVC [ Time Frame: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15 and 29 ]
  5. FEV1max [ Time Frame: pre-dose and 5, 30, 60 minutes post-dose on days 1 and 29 ]
  6. Onset of therapeutic response [ Time Frame: Days 1 and 29 ]
  7. Peak expiratory flow (PEF) [ Time Frame: pre-dose until day 29 ]
  8. Extent of use of rescue bronchodilator medication [ Time Frame: up to day 29 ]
  9. Overall incidence of adverse events [ Time Frame: up to day 29 ]
  10. Occurrence of application induced bronchoconstriction [ Time Frame: up to day 29 ]
  11. Number of patients with clinically significant changes in heart rate [ Time Frame: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15, 29 ]
  12. Number of patients with clinically significant changes in blood pressure [ Time Frame: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15, 29 ]
  13. Number of patients with abnormal findings in physical examination [ Time Frame: Baseline, day 29 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182505    
Other Study ID Numbers: 215.1105
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fenoterol
Ipratropium
Fenoterol, ipratropium drug combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents