AzTrials
AzTrials

AsthmaPhase 2NCT01458912

Study on BI 54903 (Inhaled Corticosteroid) Administered Once Daily or Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroids

A Phase 2 study testing BI 54903 MD and BI 54903 HD in people with Asthma, run by Boehringer Ingelheim.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The aim of this study is to assess and compare efficacy and safety of BI 54903 at medium doses twice daily and high doses once daily (evening dosing) and placebo over an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose inhaled corticosteroid (ICS) therapy as… Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Asthma
What is being tested?
BI 54903 MD and BI 54903 HD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2011to May 2013
Phase
Phase 2
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 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male and female patients aged at least 12 to 65 years.
  • All patients must have a history of asthma diagnosed by a physician for at least three months at the time of enrolment into the trial according to the 2009 Global Initiative for Asthma (GINA) Guidelines. The initial diagnosis of asthma must have been made before the age of 40 years.
  • All patients must be on a maintenance treatment with either medium-dose ICS plus Long-acting beta agonist (LABA) or high-dose ICS without LABA, stable for at least six weeks prior to Visit 1 (see also Section 3.3.1 and Appendix 10.3).
  • All patients must have a pre-bronchodilator FEV1 of not less than 60 to 90% of predicted normal and an ACQ-6 mean score of less than 1.5 at the pre-screening Visit 1.
  • All patients must have an improvement in FEV1 not less than 12 % above baseline and an absolute change of at least 200 mL within 15-30 min after administration of 400 mcg salbutamol/albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI). When the reversibility is not achieved at Visit 1, there will be the option to repeat reversibility test at any visit during the run-in period.
  • Variation of absolute pre-bronchodilator FEV1 values at Visit 2 as compared to Visit 1 must be within plus/minus 20 %.
Show all 12Show fewer
  • Patients must be never-smokers or ex-smokers with a smoking history of less than10 pack-years and smoking cessation at least one year prior to screening .
  • Patients must be able to use Respimat® inhaler and MDI correctly
  • Patients must be able to perform all trial-related procedures including technically acceptable pulmonary function tests and electronic PEF measurements, and must be able to maintain records during the study period as required in the protocol.
  • To enter treatment period following additional criteria have to be met (at randomisation visit):
  • All patients must have an improvement in FEV1 not less than 12 % above baseline and an absolute change of at least 200 mL within 15-30 min after administration of 400 mcg salbutamol/albuterol HFA MDI. When the reversibility is not achieved at Visit 1, there will be the option to repeat reversibility test at any visit during the run-in period.
  • During the run-in period (at the same clinic visit) all patients must be both symptomatic (ACQ-6 mean score equal to or greater than 1.5) and have shown a decrease in morning pre-bronchodilator FEV1 not less than 10% and less than or equal to 25% from pre-screening baseline FEV1 at Visit 2.

Who cannot join

  • Patients with significant pulmonary disease other than asthma or other significant medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator, result in any of the following: (i) put the patient at risk because of participation in this trial or (ii) influence the results of the trial or (iii) cause concern regarding the patient's ability to participate in the trial.
  • Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding, if the abnormality indicates a significant disease as defined in exclusion criterion no. 1.
  • Patients with a history of upper or lower respiratory tract infection (URTI/LRTI) in the past four weeks prior to the pre-screening Visit 1, and during pre-screening and run-in periods.
  • Patients with any exacerbation of their underlying asthma during the eight weeks prior to the pre-screening Visit 1.
  • Patients with active allergic rhinitis requiring treatment with systemic corticosteroids.
  • Any of the following criteria are met during the pre-screening / run-in period (Visits 1 - 6):
Show all 30Show fewer
  • in clinic pre-bronchodilator FEV1 % predicted less than 40%,
  • more than 12 puffs rescue salbutamol/albuterol HFA MDI per day for > 2 consecutive days,
  • exacerbation of asthma.
  • Patients with a history of pneumonectomy or who are planning to undergo thoracotomy for any reason.
  • Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to the first screening visit 1.
  • Patients with two or more hospitalizations for asthma within the previous 12 months.
  • Patients with a recent history of myocardial infarction during the last twelve months or known coronary heart disease that requires treatment
  • Patients with a history of hospitalisation due to heart failure in the past twelve months
  • Patients with myocarditis or any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
  • Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years
  • Patients with rheumatoid arthritis or other systemic diseases that require immune system modulating treatment
  • Patients suffering from or with a history of glaucoma, increased intraocular pressure, and/or cataracts
  • Pregnant or nursing women
  • Women of childbearing potential not using a highly effective method of birth control.
  • Patients who have been treated with anti-IgE-antibodies (e.g. omalizumab - Xolair®) or other immune system modulating antibodies such as TNF-alpha blockers within six months prior to Visit 1.
  • Patients who have been treated with the following drugs during the past four weeks prior to Visit 1 or are foreseen to need this during the study:
  • Non-selective ß-blockers (topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed),
  • Oral or other systemic corticosteroids,
  • Oral beta-agonists,
  • Changes in allergen desensitisation therapy in last 6 months,
  • Immune system modulating agents such as methotrexate or cyclosporine,
  • Inhibitors of cytochrome P450 3A4 such as antifungals (e.g. ketoconazole, itraconazole), antibiotics (e.g. erythromycin) or antiretroviral drugs.
  • Patients who have been treated with leukotriene modifiers, cromones or theophylline within two weeks prior to Visit 1.
  • Patients who have been treated with tiotropium within 3 weeks prior to Visit 1.

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of a 12-week Treatment With BI 54903 at Doses of 181.8 Mcg b.i.d. and 363.6 Mcg q.d. (p.m. Dosing) Administered Via Respimat® Inhaler in Patients With Asthma Inadequately Controlled on Low Dose ICS Therapy

The aim of this study is to assess and compare efficacy and safety of BI 54903 at medium doses twice daily and high doses once daily (evening dosing) and placebo over an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose inhaled corticosteroid (ICS) therapy as demonstrated by a decrease in Forced Expiratory Volume in one second (FEV1) (not less than 10 %, and equal to or less than 25%) and an Asthma Control Questionnaire (ACQ)-6 score of not less than 1.5 at time of randomisation.

Conditions
Asthma
Being tested
Placebo matching Respimat, BI 54903 MD, BI 54903 HD
Medical subject headings
Asthma

What participants receive

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

  • Placebo matching RespimatDrug

    2 puffs a.m. via Respimat inhaler

  • Placebo matching RespimatDrug

    2 puffs a.m. via Respimat inhaler

  • BI 54903 MDDrug

    2 puffs MD b.i.d. via Respimat inhaler

  • BI 54903 HDDrug

    2 puffs HD p.m. via Respimat inhaler

Study groups in NCT01458912
Study groupRoleWhat they receive
BI 54903 HD q.d.ExperimentalPatients receive 2 puffs BI 54903 HD q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
Receives: Drug: Placebo matching Respimat; Drug: BI 54903 HD
PlaceboPlacebo comparatorPatients receive 2 puffs Placebo b.i.d. via Respimat inhaler
Receives: Drug: Placebo matching Respimat
BI 54903 MD b.i.d.ExperimentalPatients receive 2 puffs BI 54903 MD b.i.d.via Respimat inhaler
Receives: Drug: BI 54903 MD

What is being measured

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

  1. Mean change from randomisation baseline to the end of the 12-week treatment period in evening trough (pre-dose and pre-rescue bronchodilator) FEV1

    Measured: 12 weeks

Secondary outcomes (8)

  1. Mean change from randomisation baseline to the end of the 12-week treatment period in morning and evening trough (pre-dose and pre-rescue bronchodilator) Forced Vital Capacity (FVC)

    Measured: 12 weeks

  2. Mean change from randomisation baseline in morning and evening trough (pre-dose and pre-rescue bronchodilator) FEV1 and FVC after 2, 4 and 8-week treatment periods, and in morning trough FEV1 after 12 week treatment period

    Measured: 12 weeks

  3. Mean pre-dose (and pre-rescue) Peak Expiratory Flow (PEF) as assessed via Asthma Monitor2+ (AM2+) device (in the morning and evening) of the last week of the 12-week treatment period

    Measured: 12 weeks

  4. Mean rescue medication use (daytime and night-time) as assessed via AM2+ device (in the morning and evening) of the last week of the 12-week treatment period

    Measured: 12 weeks

  5. Asthma control questionnaire (ACQ-6).

    Measured: 12 weeks

  6. Asthma quality of life questionnaire (AQLQ(S)+12)

    Measured: 12 weeks

  7. Time to withdrawal due to first asthma exacerbation

    Measured: 12 weeks

  8. Daytime 12-h FEV1 profiles after 12-week treatment period (FEV1 Area Under Curve (AUC) 0-12h)

    Measured: 12 weeks

Timeline

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

  1. First posted25 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMay 2013 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01458912
Sponsor's protocol ID
1248.3
Other IDs
2010-023166-51
Status last verified
Nov 2011
First submitted
24 Oct 2011
Last updated
23 Nov 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 54903 MD and BI 54903 HD 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 12 inclusion and 30 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: withdrawn, as of the sponsor's last update on 23 Nov 2011. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Mean change from randomisation baseline to the end of the 12-week treatment period in evening trough (pre-dose and pre-rescue bronchodilator) FEV1 (time frame: 12 weeks). 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 NCT01458912.

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 23 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in