Berodual® Respimat® Versus Berodual® Metered Aerosol (MA) Inhaler in Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Condition

July 11, 2014 updated by: Boehringer Ingelheim

Berodual® Respimat® Inhaler Versus Berodual® MA Using HFA (Hydrofluoroalkane) 134a as Propellant in Adult Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Conditions, an Open-label, Crossover Trial Over a 7-week Treatment Period With Each Formulation: ' A Study to Compare Patient Preference'

The primary objective of this study was to investigate patients acceptability / preference of Berodual® Respimat® inhaler as compared to the conventional Berodual® Metered Aerosol (MA) inhaler. Ease of handling and assembling the Respimat® inhaler at home under real life conditions was also evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of chronic obstructive pulmonary disease, asthma, or mixed conditions for a minimum of 6 months
  • Male or female patients 18 years of age or older
  • Patients who use at least 2 puffs t.i.d. of Berodual® MA HFA on regular use or at least 4 weeks prior to study
  • Patients should be able to perform all study related tests including using a peak flow meter, to perform acceptable PEFR measurements, and should be able to maintain records (Patient Daily Diary Cards) during the study period as required in the protocol
  • All patients must sign and Informed Consent Form prior to participation in the trial, i.e., prior to the run-in period in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP)

Exclusion Criteria:

  • Patients with significant disease other than chronic airways obstruction (CAO) will be excluded. A 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 a disease which may influence the results of the study or the patient's ability to participate in the study
  • Patients with a recent history (i.e., six months - or less) of myocardial infarction
  • Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalized for heart failure within the past three years, including patients with hypertrophic cardiomyopathy and tachyarrhythmia
  • Patients who regularly use oxygen therapy
  • Patients with known active tuberculosis
  • Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
  • Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
  • Patients who have undergone thoracotomy with pulmonary resection. Patients with history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1
  • Patients with any upper or lower respiratory infection in the past six weeks prior to the screening visit (Visit 1) or during the run-in period
  • Patients hospitalized or having had visits to the emergency room in the past six weeks before run-in period
  • Patients who are currently in a pulmonary rehabilitation programme that will not be maintained throughout the duration of the study or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit (Visit 1)
  • Patients with known hypersensitivity to anticholinergic drugs or any other components of the trial medication including excipients
  • Patients medically treated for prostatic hyperplasia or bladder neck obstruction
  • Patients with known narrow-angle glaucoma or raised intra-ocular pressure
  • Patients who are being treated with beta-blocker medications Note: beta1-blocker eye medications for treatment of non-narrow angle glaucoma are allowed
  • Patients using oral corticosteroid medication at unstable dose (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day
  • Patients on inhaled or short-acting beta-adrenergics other than the study medication
  • Patients on inhaled or short-acting beta-anticholinergics other than the study medication
  • Patients taking monoamine oxidase inhibitors
  • Patients taking tricyclic antidepressants
  • Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months (i.e., oral contraceptives, intrauterine inhalers, diaphragm or subdermal implants)
  • Patients with a history of and/or active significant alcohol or drug abuse
  • Patients who have taken an investigational drug within one month or six half-lives (whichever is greater) prior to the screening visit (Visit 1)
  • Patients who have already been enrolled and randomised to a treatment group in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Berodual® Respimat® - Berodual® MA HFA

randomized sequence

  1. Berodual® Respimat® (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per actuation for 49 days)
  2. Berodual® MA HFA (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per puff for 49 days)
Drug: Berodual® Respimat®
Drug: Berodual® MA HFA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient's assessment of inhaler preference
Time Frame: Day 98
patient preference questionnaire
Day 98

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rating of inhaler satisfaction
Time Frame: Day 49 and 98
patient satisfaction questionnaire
Day 49 and 98
Rating of willingness to continue using inhaler
Time Frame: Day 98
patient preference questionnaire
Day 98
Post-dose PEFRpm (Peak expiratory flow rate)
Time Frame: 30 minutes post-dose up to day 98
30 minutes post-dose up to day 98
Retention of inhaler technique
Time Frame: day 49 and 98 (after 7 weeks of treatment)
proficiency questionnaire
day 49 and 98 (after 7 weeks of treatment)
Use of rescue medication
Time Frame: up to day 98
up to day 98
Daytime and night-time symptom scores
Time Frame: up to day 98
up to day 98

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 215.1357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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