Clinical trial NCT01103349: BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
Official title: Randomised, Double Blind, Double Dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 6 Weeks of Oral BI 671800 ED Twice Daily (b.i.d.), Montelukast Once Daily (q.d.) or Placebo in Symptomatic Asthmatic Patients on Low Dose Fluticasone Propionate MDI (Metered Dose Inhaler)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-04-14
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

1. Signed informed consent consistent with ICH-GCP
2. 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%.
3. Stable inhaled corticosteroids (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 randomisation.
6. Male or female 18 to 65 years.
7. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.
8. Able to perform pulmonary function testing.

Exclusion criteria:

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

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
timeFrame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.
Secondary outcomes:
measure: Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment
timeFrame: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.
Other outcomes:
Locations:
city: Denver
country: United States
facility: 1268.16.01004 Boehringer Ingelheim Investigational Site
state: Colorado
city: North Dartmouth
country: United States
facility: 1268.16.01001 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Plymouth
country: United States
facility: 1268.16.01006 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Portland
country: United States
facility: 1268.16.01003 Boehringer Ingelheim Investigational Site
state: Oregon
city: Charleston
country: United States
facility: 1268.16.01002 Boehringer Ingelheim Investigational Site
state: South Carolina
city: El Paso
country: United States
facility: 1268.16.01005 Boehringer Ingelheim Investigational Site
state: Texas
city: Feldbach
country: Austria
facility: 1268.16.43002 Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1268.16.49018 Boehringer Ingelheim Investigational Site
city: Bamberg
country: Germany
facility: 1268.16.49014 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1268.16.49001 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1268.16.49004 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1268.16.49010 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1268.16.49012 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1268.16.49013 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1268.16.49016 Boehringer Ingelheim Investigational Site
city: Erfurt
country: Germany
facility: 1268.16.49008 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1268.16.49005 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1268.16.49015 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1268.16.49011 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1268.16.49009 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1268.16.49017 Boehringer Ingelheim Investigational Site
city: Koblenz
country: Germany
facility: 1268.16.49007 Boehringer Ingelheim Investigational Site
city: Lübeck
country: Germany
facility: 1268.16.49006 Boehringer Ingelheim Investigational Site
city: Rüdersdorf
country: Germany
facility: 1268.16.49002 Boehringer Ingelheim Investigational Site
city: Weinheim
country: Germany
facility: 1268.16.49003 Boehringer Ingelheim Investigational Site
city: Ferrara
country: Italy
facility: 1268.16.39006 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1268.16.39007 Boehringer Ingelheim Investigational Site
city: Pietra Ligure (SV)
country: Italy
facility: 1268.16.39004 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1268.16.39001 Boehringer Ingelheim Investigational Site
city: Anyang
country: Korea, Republic of
facility: 1268.16.82008 Boehringer Ingelheim Investigational Site
city: Bucheon
country: Korea, Republic of
facility: 1268.16.82009 Boehringer Ingelheim Investigational Site
city: Cheongju
country: Korea, Republic of
facility: 1268.16.82007 Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: 1268.16.82006 Boehringer Ingelheim Investigational Site
city: Gwangju
country: Korea, Republic of
facility: 1268.16.82010 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1268.16.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1268.16.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1268.16.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1268.16.82005 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1268.16.82003 Boehringer Ingelheim Investigational Site
city: Christchurch NZ
country: New Zealand
facility: 1268.16.64001 Boehringer Ingelheim Investigational Site
city: Greenlane East Auckland
country: New Zealand
facility: 1268.16.64003 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1268.16.46002 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1268.16.46001 Boehringer Ingelheim Investigational Site
city: Örebro
country: Sweden
facility: 1268.16.46003 Boehringer Ingelheim Investigational Site
city: Bursa
country: Turkey
facility: 1268.16.90002 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1268.16.90003 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1268.16.90004 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1268.16.90006 Boehringer Ingelheim Investigational Site
city: Mersin
country: Turkey
facility: 1268.16.90001 Boehringer Ingelheim Investigational Site
city: Chertsey
country: United Kingdom
facility: 1268.16.44005 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1268.16.44004 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1268.16.44002 Boehringer Ingelheim Investigational Site
city: Southampton
country: United Kingdom
facility: 1268.16.44003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: