BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.

Key facts

Study ID

NCT01103349

Run by

Boehringer Ingelheim

People needed

243

Starts

2010-04-20

Expected to finish

2011-08-09

Last updated by the study team

2022-05-31

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 ICH-GCP
• Three month history of reversible (12% and 200 mL in forced expiratory volume in one second - FEV1) asthma (according to GINA) with following spirometry at randomisation: FEV1 60%- 85%.
• Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.
• Diagnosis of asthma prior to 40 years.
• Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.
• Male or female 18 to 65 years.
• Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.
• Able to perform pulmonary function testing.

You may not qualify if…

• Significant diseases other than asthma or allergic rhinitis.
• Hepatic transaminases or total bilirubin greater than 1.5 ULN.
• Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.
• Uncontrolled asthma on iCS + other controller.
• Respiratory tract infection or exacerbation within 4 weeks.
• FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period.
• Participation in another interventional study.
• Pregnant or nursing women.
• Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.

Where it is running

• 1268.16.01001 Boehringer Ingelheim Investigational Site — North Dartmouth, Massachusetts, United States
• 1268.16.01006 Boehringer Ingelheim Investigational Site — Plymouth, Minnesota, United States
• 1268.16.01003 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States
• 1268.16.01002 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1268.16.01005 Boehringer Ingelheim Investigational Site — El Paso, Texas, United States
• 1268.16.43002 Boehringer Ingelheim Investigational Site — Feldbach, Austria
• 1268.16.49018 Boehringer Ingelheim Investigational Site — Aschaffenburg, Germany
• 1268.16.49014 Boehringer Ingelheim Investigational Site — Bamberg, Germany
• 1268.16.49001 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1268.16.49004 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1268.16.49010 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1268.16.49012 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1268.16.49013 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1268.16.49016 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1268.16.49008 Boehringer Ingelheim Investigational Site — Erfurt, Germany
• 1268.16.49005 Boehringer Ingelheim Investigational Site — Frankfurt, Germany
• 1268.16.49015 Boehringer Ingelheim Investigational Site — Frankfurt, Germany
• 1268.16.49011 Boehringer Ingelheim Investigational Site — Hamburg, Germany
• 1268.16.49009 Boehringer Ingelheim Investigational Site — Hanover, Germany
• 1268.16.49017 Boehringer Ingelheim Investigational Site — Hanover, Germany
• 1268.16.49007 Boehringer Ingelheim Investigational Site — Koblenz, Germany
• 1268.16.49006 Boehringer Ingelheim Investigational Site — Lübeck, Germany
• 1268.16.49002 Boehringer Ingelheim Investigational Site — Rüdersdorf, Germany
• 1268.16.49003 Boehringer Ingelheim Investigational Site — Weinheim, Germany
• 1268.16.01004 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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