Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid in symptomatic asthma patients.

Key facts

Study ID

NCT01090024

Run by

Boehringer Ingelheim

People needed

108

Starts

2010-03-01

Expected to finish

2011-02-18

Last updated by the study team

2022-05-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
• Three month history of reversible (12% with 200 mL) asthma according to [Global Initiative for Asthma (GINA)] with following spirometry at randomization:forced expiratory volume in 1 second (FEV1) 60%-85%.
• Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
• Diagnosis of asthma prior to 40 years.
• Asthma Control Questionnaire (ACQ) at least 1.5 at randomization.
• Male or female, 18 to 65 years.
• Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
• Able to perform pulmonary function test (PFT).

You may not qualify if…

• Significant diseases other than asthma or allergic rhinitis.
• Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
• Hospitalizations for asthma or asthma related intubation within 3 months.
• Uncontrolled asthma on ICS + another controller.
• Respiratory tract infection or exacerbation within 4 weeks.
• FEV1 less than 40%, more than 12 puffs of short acting beta agonists (SABA) on more than two consecutive days or asthma exacerbation during the run-in period.
• Participation in another interventional study.
• Pregnant or nursing women.
• Women of child bearing potential nor using appropriate methods of birth control as defined by protocol.

Where it is running

• 1268.53.01013 Boehringer Ingelheim Investigational Site — Huntington Beach, California, United States
• 1268.53.01014 Boehringer Ingelheim Investigational Site — Mission Viejo, California, United States
• 1268.53.01002 Boehringer Ingelheim Investigational Site — Stockton, California, United States
• 1268.53.01009 Boehringer Ingelheim Investigational Site — Colorado Springs, Colorado, United States
• 1268.53.01011 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1268.53.01001 Boehringer Ingelheim Investigational Site — North Dartmouth, Massachusetts, United States
• 1268.53.01005 Boehringer Ingelheim Investigational Site — Minneapolis, Minnesota, United States
• 1268.53.01006 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1268.53.01007 Boehringer Ingelheim Investigational Site — Raleigh, North Carolina, United States
• 1268.53.01010 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States
• 1268.53.01003 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1268.53.01008 Boehringer Ingelheim Investigational Site — El Paso, Texas, United States
• 1268.53.01012 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1268.53.01015 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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