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

Phase 2

Terminated

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: BI 54903; Drug: Fluticasone propionate

• Registration Number: NCT01397162
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Study Start: 2011-07-21
• Primary Completion: 2011-12-23
• Study Completion: 2011-12-23
• Disposition First Submitted: 2014-04-30
• Disposition First Submitted QC: 2014-04-30
• Disposition First Posted: 2014-05-16
• Results First Submitted: 2022-04-06
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Results First Posted: 2022-06-23
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Respimat inhaler 2 puffs b.i.d. and placebo HFA MDI, 2 puffs b.i.d.
BI 54903 - medium dose	BI 54903	BI 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	BI 54903	BI 54903 high dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d.
BI 54903 - low dose	BI 54903	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.
Fluticasone propionate	Fluticasone propionate	Fluticasone propionate 2 puffs twice b.i.d via HFA MDI plus placebo BI 54903 via Respimat inhaler 2 puffs b.i.d.

Primary Outcome Measures

Name	Time	Method
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)	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).

Secondary Outcome Measures

Name	Time	Method
Time to Withdrawal Due to First Asthma Exacerbation	At week 8.	Time to withdrawal due to first asthma exacerbation.
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	At baseline and at week 2 and 4.	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 Vital Capacity (FVC) After 2, 4 and 8-week Treatment Periods	At baseline and week 2, 4, 8.	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 (Morning Pre-dose and Prerescue Bronchodilator) FEF25-75 After 2, 4 and 8-week Treatment Periods	At baseline and at week 2, 4 and 8.	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.
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	At week 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 Change From Randomisation Baseline in Asthma Control Questionnaire (ACQ-6) Scores at Subsequent Study Visits	At baseline and at week 2, 4 and 8.	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.
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	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 Change From Randomisation Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)+12) Scores at Subsequent Study Visits	At baseline and at week 2, 4 and 8.	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.

Trial Locations

Locations (41)

1248.5.01047 Boehringer Ingelheim Investigational Site; 🇺🇸 Fountain Valley, California, United States

1248.5.01041 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntington Beach, California, United States

1248.5.01038 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1248.5.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Mission Viejo, California, United States

1248.5.01028 Boehringer Ingelheim Investigational Site; 🇺🇸 Palmdale, California, United States

1248.5.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 Rancho Mirage, California, United States

1248.5.01044 Boehringer Ingelheim Investigational Site; 🇺🇸 Stockton, California, United States

1248.5.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 Centennial, Colorado, United States

1248.5.01022 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1248.5.01042 Boehringer Ingelheim Investigational Site; 🇺🇸 Sarasota, Florida, United States

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