AsthmaPhase 2NCT01397162

Dose Finding Study on BI54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat® Inhaler in Asthmatic Patients Inadequately Controlled on Short-acting-beta-agonist (SABA) Therapy

A Phase 2 study testing Fluticasone propionate and BI 54903 in people with Asthma, run by Boehringer Ingelheim at 41 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 12 to 65 years
Conditions the study is for: Asthma
What is being tested?: Fluticasone propionate and BI 54903
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 41 sitesUnited States
Study dates: 21 Jul 2011to 23 Dec 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 4 All patients must be on a maintenance treatment with either low-dose inhaled corticosteroid (ICS) plus long-acting-beta -agonist (LABA) or medium-dose ICS without LABA, stable for at least six weeks prior to Visit 1
5 All patients must have a pre-bronchodilator FEV1 of not less than 60 to 90% of predicted normal and an asthma control questionnaire (ACQ-6) mean score of less than 1.5 at the pre-screening Visit 1 6 All patients must have an improvement in forced expiratory volume in one second (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 metered dose inhaler (HFA MDI) 7 Patients must be 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 9 Patients must be able to use Respimat® inhaler and metered dose inhaler (MDI) correctly 10 Patients must be able to perform all trial-related procedures including technically acceptable pulmonary function tests and electronic peak expiratory flow (PEF) measurements, and must be able to maintain records during the study period as required in the protocol

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)
Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding
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):in clinic pre-bronchodilator forced expiratory volume in one second (FEV1 %) predicted less than 40%; more than 12 puffs rescue salbutamol/albuterol HFA MDI per day for > 2 consecutive days;exacerbation of asthma

Show all 19Show fewer

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 narrow angle glaucoma 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-Immunoglobin-E-antibodies (e.g. omalizumab, Xolair®) or other immune system modulating antibodies such as tumor necrosis factor-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 beta-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, chromones or theophylline within two weeks prior to Visit 1; Patients who have been treated with tiotropium within 3 weeks prior to Visit 1

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

1248.5.01053 Boehringer Ingelheim Investigational Site
Alexandria, Virginia
1248.5.01050 Boehringer Ingelheim Investigational Site
Austin, Texas
1248.5.01019 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1248.5.01049 Boehringer Ingelheim Investigational Site
Berlin, New Jersey
1248.5.01015 Boehringer Ingelheim Investigational Site
Centennial, Colorado
1248.5.01048 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1248.5.01045 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1248.5.01051 Boehringer Ingelheim Investigational Site
Columbus, Georgia
1248.5.01011 Boehringer Ingelheim Investigational Site
Eagle, Idaho
1248.5.01047 Boehringer Ingelheim Investigational Site
Fountain Valley, California
1248.5.01005 Boehringer Ingelheim Investigational Site
Gresham, Oregon
1248.5.01031 Boehringer Ingelheim Investigational Site
High Point, North Carolina
1248.5.01041 Boehringer Ingelheim Investigational Site
Huntington Beach, California
1248.5.01002 Boehringer Ingelheim Investigational Site
Live Oak, Texas
1248.5.01038 Boehringer Ingelheim Investigational Site
Long Beach, California
1248.5.01022 Boehringer Ingelheim Investigational Site
Miami, Florida
1248.5.01004 Boehringer Ingelheim Investigational Site
Mission Viejo, California
1248.5.01025 Boehringer Ingelheim Investigational Site
Murray, Utah
1248.5.01039 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1248.5.01055 Boehringer Ingelheim Investigational Site
Oak Lawn, Illinois
1248.5.01020 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1248.5.01028 Boehringer Ingelheim Investigational Site
Palmdale, California
1248.5.01013 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1248.5.01040 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1248.5.01021 Boehringer Ingelheim Investigational Site
Portland, Oregon
1248.5.01014 Boehringer Ingelheim Investigational Site
Rancho Mirage, California
1248.5.01006 Boehringer Ingelheim Investigational Site
Rochester, New York
1248.5.01056 Boehringer Ingelheim Investigational Site
Rolla, Missouri
1248.5.01032 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1248.5.01046 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1248.5.01042 Boehringer Ingelheim Investigational Site
Sarasota, Florida
1248.5.01052 Boehringer Ingelheim Investigational Site
Savannah, Georgia
1248.5.01044 Boehringer Ingelheim Investigational Site
Stockton, California
1248.5.01030 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1248.5.01054 Boehringer Ingelheim Investigational Site
Trenton, New Jersey
1248.5.01012 Boehringer Ingelheim Investigational Site
Upland, Pennsylvania
1248.5.01010 Boehringer Ingelheim Investigational Site
Verona, New Jersey
1248.5.01001 Boehringer Ingelheim Investigational Site
Waco, Texas
1248.5.01007 Boehringer Ingelheim Investigational Site
Waco, Texas
1248.5.01036 Boehringer Ingelheim Investigational Site
Warrensburg, Missouri
1248.5.01037 Boehringer Ingelheim Investigational Site
Ypsilanti, Michigan

Other trials in United States

About this study

Official title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of an 8-week Treatment With BI 54903 at Doses of 22.7, 45.5 and 90.9 Doses b.i.d. Administered Via Respimat® Inhaler and Fluticasone Propionate HFA MDI 88 mcg b.i.d. in Patients With Asthma Inadequately Controlled on SABA Therapy

The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.) and fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 88 mcg b.i.d and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on short-acting-beta-agonist (SABA) prn therapy only as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range10 to 25% and an asthma control questionnaire (ACQ-6) equal or greater than 1.5 at time of randomization

Conditions: Asthma
Being tested: Fluticasone propionate, Placebo, BI 54903
Medical subject headings: Asthma

What participants receive

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

Fluticasone propionateDrug
Fluticasone propionate
PlaceboDrug
Placebo matching fluticasone propionate HFA MDI
BI 54903Drug
BI 54903

Study groups in NCT01397162
Study group	Role	What they receive
BI 54903 - low dose	Experimental	BI 54903 low dose 2 puffs twice daily (b.i.d.) via Respimat inhaler plus hydrofluoralkane (HFA) metered dose inhaler (MDI) matching placebo 2 puffs b.i.d. Receives: Drug: BI 54903
BI 54903 - medium dose	Experimental	BI 54903 medium dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d. Receives: Drug: BI 54903
BI 54903 - high dose	Experimental	BI 54903 high dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d. Receives: Drug: BI 54903
Fluticasone propionate	Active comparator	Fluticasone propionate 2 puffs twice b.i.d via HFA MDI plus placebo BI 54903 via Respimat inhaler 2 puffs b.i.d. Receives: Drug: Fluticasone propionate
Placebo	Placebo comparator	Placebo Respimat inhaler 2 puffs b.i.d. and placebo HFA MDI, 2 puffs b.i.d. Receives: Drug: Placebo

What is being measured

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

Mean Change From the Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Morning Pre-dose and Pre-rescue Bronchodilator ) Forced Expiratory Volume in One Second (FEV1)
Mean change from the randomisation baseline to the end of the 8-week treatment period in trough (morning pre-dose and pre-rescue bronchodilator ) forced expiratory volume in one second (FEV1).
Measured: At baseline and week 8.

Secondary outcomes (8)

Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1) After 2 and 4-week Treatment Periods
Mean changes from randomisation baseline in trough (pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1) after 2 and 4-week treatment periods.
Measured: At baseline and at week 2 and 4.
Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Vital Capacity (FVC) After 2, 4 and 8-week Treatment Periods
Mean changes from randomisation baseline in trough (pre-dose and pre-rescue bronchodilator) forced vital capacity (FVC) after 2, 4 and 8-week treatment periods.
Measured: At baseline and week 2, 4, 8.
Mean Changes From Randomisation Baseline in Trough (Morning Pre-dose and Prerescue Bronchodilator) FEF25-75 After 2, 4 and 8-week Treatment Periods
Mean change from randomization baseline in through (morning pre-dose and pre-rescue bronchodilator) Forced expiratory flow between 25% and 75% of vital capacity (FEF 25-75) after 2, 4 and 8-week treatment periods.
Measured: At baseline and at week 2, 4 and 8.
Mean Pre-dose (and Pre-rescue) Peak Expiratory Flow (PEF) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period
Mean pre-dose (and pre-rescue) peak expiratory flow (PEF) as assessed via asthma monitor (AM2+) in the morning and evening of the last week of the 8-week treatment period.
Measured: At week 8.
Mean Rescue Medication Use (Daytime and Night-time) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period
Mean rescue medication use (daytime and night-time) as assessed via asthma monitor (AM2+) in the morning and evening, of the last week of the 8-week treatment period.
Measured: At week 8.
Mean Change From Randomisation Baseline in Asthma Control Questionnaire (ACQ-6) Scores at Subsequent Study Visits
The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 6 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of less than or equal to 0.75 indicate well-controlled asthma, scores between 0.76 and less than 1.5 indicate partly controlled asthma, and a score greater than or equal to 1.5 indicates uncontrolled asthma.
Measured: At baseline and at week 2, 4 and 8.
Mean Change From Randomisation Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)+12) Scores at Subsequent Study Visits
AQLQ(S)+12 are well established and validated questionnaires to measure control of asthma symptoms and quality of life, which is a patient-reported self-administered outcome questionnaire containing 32 items. Each item is scored on a 7-point scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Measured: At baseline and at week 2, 4 and 8.
Time to Withdrawal Due to First Asthma Exacerbation
Time to withdrawal due to first asthma exacerbation.
Measured: At week 8.

Timeline

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

21 Jul 201123 Dec 2011

First posted19 Jul 2011 (estimated)
Study start21 Jul 2011
Primary completion23 Dec 2011
Study completion23 Dec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01397162
Sponsor's protocol ID: 1248.5
Other IDs: 2010-023167-17
Status last verified: May 2022
First submitted: 18 Jul 2011
Last updated: 23 Jun 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of an 8-week Treatment With BI 54903 at Doses of 22.7, 45.5 and 90.9 Doses b.i.d. Administered Via Respimat® Inhaler and Fluticasone Propionate HFA MDI 88 mcg b.i.d. in Patients With Asthma Inadequately Controlled on SABA Therapy
ClinicalTrials.gov ID: NCT01397162
Acronym / sponsor ID: 1248.5
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 29 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 21 Jul 2011 (actual)
Primary completion: 23 Dec 2011 (actual)
Study completion: 23 Dec 2011 (actual)
First posted: 19 Jul 2011 (estimated)
Results: Posted 23 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 5

Arm	Type	Receives
BI 54903 - low dose	Experimental	Drug: BI 54903BI 54903 low dose 2 puffs twice daily (b.i.d.) via Respimat inhaler plus hydrofluoralkane (HFA) metered dose inhaler (MDI) matching placebo 2 puffs b.i.d.
BI 54903 - medium dose	Experimental	Drug: BI 54903BI 54903 medium dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d.
BI 54903 - high dose	Experimental	Drug: BI 54903BI 54903 high dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d.
Fluticasone propionate	Active comparator	Drug: Fluticasone propionateFluticasone propionate 2 puffs twice b.i.d via HFA MDI plus placebo BI 54903 via Respimat inhaler 2 puffs b.i.d.
Placebo	Placebo comparator	Drug: PlaceboPlacebo Respimat inhaler 2 puffs b.i.d. and placebo HFA MDI, 2 puffs b.i.d.

Who may qualify

Ages: 12 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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 4 All patients must be on a maintenance treatment with either low-dose inhaled corticosteroid (ICS) plus long-acting-beta -agonist (LABA) or medium-dose ICS without LABA, stable for at least six weeks prior to Visit 1
5 All patients must have a pre-bronchodilator FEV1 of not less than 60 to 90% of predicted normal and an asthma control questionnaire (ACQ-6) mean score of less than 1.5 at the pre-screening Visit 1 6 All patients must have an improvement in forced expiratory volume in one second (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 metered dose inhaler (HFA MDI) 7 Patients must be 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 9 Patients must be able to use Respimat® inhaler and metered dose inhaler (MDI) correctly 10 Patients must be able to perform all trial-related procedures including technically acceptable pulmonary function tests and electronic peak expiratory flow (PEF) measurements, and must be able to maintain records during the study period as required in the protocol

Key exclusion criteria (19 listed)

Patients with significant pulmonary disease other than asthma or other significant medical conditions (as determined by medical history, examination and clinical investigations at screening)
Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluticasone propionateFluticasone propionate	Drug	Fluticasone propionate
PlaceboPlacebo matching fluticasone propionate HFA MDI	Drug	Placebo
BI 54903BI 54903	Drug	BI 54903 - high dose, BI 54903 - low dose, BI 54903 - medium dose

Primary outcome

Mean Change From the Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Morning Pre-dose and Pre-rescue Bronchodilator ) Forced Expiratory Volume in One Second (FEV1)
Time frame: At baseline and week 8.
Mean change from the randomisation baseline to the end of the 8-week treatment period in trough (morning pre-dose and pre-rescue bronchodilator ) forced expiratory volume in one second (FEV1).

8 secondary outcomes

Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1) After 2 and 4-week Treatment Periods
Time frame: At baseline and at week 2 and 4.
Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Vital Capacity (FVC) After 2, 4 and 8-week Treatment Periods
Time frame: At baseline and week 2, 4, 8.
Mean Changes From Randomisation Baseline in Trough (Morning Pre-dose and Prerescue Bronchodilator) FEF25-75 After 2, 4 and 8-week Treatment Periods
Time frame: At baseline and at week 2, 4 and 8.
Mean Pre-dose (and Pre-rescue) Peak Expiratory Flow (PEF) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period
Time frame: At week 8.
Mean Rescue Medication Use (Daytime and Night-time) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period
Time frame: At week 8.
Mean Change From Randomisation Baseline in Asthma Control Questionnaire (ACQ-6) Scores at Subsequent Study Visits
Time frame: At baseline and at week 2, 4 and 8.
Mean Change From Randomisation Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)+12) Scores at Subsequent Study Visits
Time frame: At baseline and at week 2, 4 and 8.
Time to Withdrawal Due to First Asthma Exacerbation
Time frame: At week 8.

Results and safety

Results posted to the registry on 23 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo HFA MDI	8	1
BI 54903 22.7µg Bid	5	1
BI 54903 45.5µg Bid	4	1
BI 54903 90.9µg Bid	6	1
Fluticasone Propionate 88µg Bid	6	3

Primary outcome: Mean Change From the Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Morning Pre-dose and Pre-rescue Bronchodilator ) Forced Expiratory Volume in One Second (FEV1)

Time frame: At baseline and week 8.

Population analysed: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
BI 54903 22.7µg Bid	0 of 5 (0%)	0 of 5 (0%)	0 of 5
BI 54903 45.5µg Bid	0 of 4 (0%)	0 of 4 (0%)	0 of 4
BI 54903 90.9µg Bid	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Fluticasone Propionate 88µg Bid	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): Study was terminated by the decision of the sponsor. As limited data were collected due to early termination and only limited number of patients completed the 8-week treatment period, no analyses of primary and secondary endpoints were conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluticasone propionate and BI 54903 in people with Asthma, run by Boehringer Ingelheim at 41 sites in United States.

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 3 inclusion and 19 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: stopped early, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 23 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 the Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Morning Pre-dose and Pre-rescue Bronchodilator ) Forced Expiratory Volume in One Second (FEV1) (time frame: At baseline and week 8.). 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 NCT01397162.

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 Jun 2022.