Phase 2
Completed N=389
BI 671800 ED in Steroid-naive Asthmatic Patients
Source: ClinicalTrials.gov NCT01092143 ↗Enrolled (actual)
389
Serious AEs
0.5%
Results posted
May 2022
Primary outcomePrimary: 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 — -2.010; 1.073; 1.580; 1.967 FEV1 percent predicted — p=0.0311
Summary
This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-2.010; 1.073; 1.580; 1.967; 6.610 | 0.0311 sig |
| SECONDARY Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment |
-0.616; -0.543; -0.696; -0.677; -0.949 | 0.7413 |
Eligibility Criteria
Inclusion criteria
- Signed informed consent consistent with ICH-GCP
- Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
- No ICS previous 3 months prior to screening.
- Diagnosis of asthma prior to 40 years.
- 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 PFT
Exclusion criteria
- Significant diseases other than asthma or allergic rhinitis.
- Hepatic transaminases or total bilirubin greater than 1.5 ULN.
- Hospitalizations for asthma or asthma related intubation within 3 months.
- Uncontrolled asthma.
- Respiratory tract infection or exacerbation within 4 weeks.
- FEV1 less than 40%, more than 12 puffs of 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
Data sourced from ClinicalTrials.gov (NCT01092143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.