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AsthmaPhase 3NCT02182505

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

A Phase 3 study testing Berodual® Respimat®, low dose, Berodual® Respimat®, high dose and Berodual® MDI in people with Asthma, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 6 to 15 years
Conditions the study is for
Asthma
What is being tested?
Berodual® Respimat®, low dose, Berodual® Respimat®, high dose and Berodual® MDI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
535 participants
Where
No sites listed yet
Study dates
Sep 1998to Jul 1999
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

About this study

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 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.

Conditions
Asthma
Being tested
Berodual® Respimat®, low dose, Berodual® Respimat®, high dose, Berodual® MDI
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Berodual® Respimat®, low doseDrug

  • Berodual® Respimat®, high doseDrug

  • Berodual® MDIDrug

Study groups in NCT02182505
Study groupRoleWhat they receive
Berodual® Respimat®, low doseExperimentalNot described
Receives: Drug: Berodual® Respimat®, low dose
Berodual® Respimat®, high doseExperimentalNot described
Receives: Drug: Berodual® Respimat®, high dose
Berodual® MDI Aerochamber®Active comparatorNot described
Receives: Drug: Berodual® MDI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 ))

    Measured: pre-dose and 5, 30, 60 minutes post-dose on day 29

Secondary outcomes (13)

  1. Average FEV1 between 0 and 1 hour (FEV1 AUC0-1)

    Measured: 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)

    Measured: pre-dose and 5, 30, 60 minutes post-dose on day 29

  3. FVC (Forced vital capacity)

    Measured: 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

    Measured: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15 and 29

  5. FEV1max

    Measured: pre-dose and 5, 30, 60 minutes post-dose on days 1 and 29

  6. Onset of therapeutic response

    Measured: Days 1 and 29

  7. Peak expiratory flow (PEF)

    Measured: pre-dose until day 29

  8. Extent of use of rescue bronchodilator medication

    Measured: up to day 29

  9. Overall incidence of adverse events

    Measured: up to day 29

  10. Occurrence of application induced bronchoconstriction

    Measured: up to day 29

  11. Number of patients with clinically significant changes in heart rate

    Measured: 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

    Measured: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15, 29

  13. Number of patients with abnormal findings in physical examination

    Measured: Baseline, day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2014 (estimated)
  2. Study startSep 1998
  3. Primary completionJul 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182505
Sponsor's protocol ID
215.1105
Status last verified
Jul 2014
First submitted
2 Jul 2014
Last updated
14 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Berodual® Respimat®, low dose, Berodual® Respimat®, high dose and Berodual® MDI in people with Asthma, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02182505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.

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