Olodaterol Bridging Study in Asthma

November 21, 2011 updated by: Boehringer Ingelheim

Single Dose Comparison of 3 Doses of Olodaterol in Double Fixed Dose Combination With BI54903 vs. 3 Doses of Olodaterol Mono in Free Combination

The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).

Study Overview

Status

Status

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Withdrawn

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

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 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gières, France
        • 1249.7.33003 Boehringer Ingelheim Investigational Site

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Informed Consent Form consistent guidelines and local legislation prior
  2. Male or female patients aged at least 18 to 75 years.
  3. Diagnosis of asthma according to the 2009 Global Initiative for Asthma (GINA) Guidelines.
  4. Maintenance treatment with a low or medium dose of inhaled corticosteroids (ICS) with or without Long-acting beta-adrenergic (LABA), stable dose of inhaled corticosteroids (alone or in a fixed combination with a LABA) for at least for 6 weeks prior to screening.
  5. Asthma control questionaire (ACQ)-6 mean score of < 1.5.
  6. a. Pre-bronchodilator clinic measured FEV1 =50% and =90% of predicted normal b. FEV1 reversibility: Improvement in FEV1 =12% above baseline and an absolute change of at least 200 ml within 15-30 minutes after administration of 400 µg salbutamol.
  7. Never-smokers or ex-smokers with a smoking history of less than 10 pack-years and smoking cessation at least one year prior to screening.
  8. Be able to use the inhalers correctly in the opinion of the investigator.
  9. Be able to perform all trial related procedures.

Exclusion criteria:

  1. Significant disease other than asthma.
  2. Recent history (i.e. six months or less) of myocardial infarction.
  3. Hospitalisation for cardiac failure during the past year.
  4. Unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
  5. Lung diseases other than asthma (e.g. Chronic obstructive pulmonary disease).
  6. Active tuberculosis.
  7. Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
  8. Thoracotomy with pulmonary resection.
  9. Alcohol or drug abuse within the past two years.
  10. Pulmonary rehabilitation program
  11. Hypersensitivity to LABA drugs, ciclesonide, salmeterol or any other components of the study medication delivery systems.
  12. Pregnant or nursing woman.
  13. Women of childbearing potential not using a highly effective method of birth control.

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
  • Masking: DOUBLE

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.
PLACEBO_COMPARATOR: Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
EXPERIMENTAL: Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
ACTIVE_COMPARATOR: Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
EXPERIMENTAL: Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
EXPERIMENTAL: Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
EXPERIMENTAL: Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
EXPERIMENTAL: Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution

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
Time Frame
FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve
Time Frame: 12 hours
12 hours

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
Time Frame
FEV1 (AUC0-24h)
Time Frame: 24 hours
24 hours
FEV1 (AUC12-24h)
Time Frame: 12 hours
12 hours
Peak FEV1
Time Frame: 12 hours
12 hours

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

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, 2011

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).
August 25, 2011

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.
August 29, 2011

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.
September 5, 2011

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.
November 22, 2011

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.
November 21, 2011

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.
November 1, 2011

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.
  • 1249.7
  • 2011-000935-98 (EUDRACT_NUMBER: EudraCT)

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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