Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: BI 671800; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01090024

1268.53

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
2. 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%.
3. Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
4. Diagnosis of asthma prior to 40 years.
5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomization.
6. Male or female, 18 to 65 years.
7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
8. Able to perform pulmonary function test (PFT).

Exclusion criteria

1. Significant diseases other than asthma or allergic rhinitis.
2. Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
3. Hospitalizations for asthma or asthma related intubation within 3 months.
4. Uncontrolled asthma on ICS + another controller.
5. Respiratory tract infection or exacerbation within 4 weeks.
6. 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.
7. Participation in another interventional study.
8. Pregnant or nursing women.
9. Women of child bearing potential nor using appropriate methods of birth control as defined by protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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108 participants in 4 patient groups, including a placebo group

BI 671800 AM and PM

Experimental group

Description:

Patients receiving two capsules twice daily

Treatment:

Drug: BI 671800

BI 671800 AM

Experimental group

Description:

Patients receiving four capsules in the morning

Treatment:

Drug: BI 671800

BI 671800 PM

Experimental group

Description:

Patients receiving four capsules in the evening

Treatment:

Drug: BI 671800

Placebo

Placebo Comparator group

Description:

Patients receiving four capsules twice a day

Treatment:

Drug: Placebo