Asthma Clinical Trial
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)
| Verified date | May 2022 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 243 |
| Est. completion date | August 9, 2011 |
| Est. primary completion date | August 9, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | 1268.16.43002 Boehringer Ingelheim Investigational Site | Feldbach | |
| Germany | 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 | Hannover | |
| Germany | 1268.16.49017 Boehringer Ingelheim Investigational Site | Hannover | |
| 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 | |
| Italy | 1268.16.39006 Boehringer Ingelheim Investigational Site | Ferrara | |
| Italy | 1268.16.39007 Boehringer Ingelheim Investigational Site | Milano | |
| Italy | 1268.16.39004 Boehringer Ingelheim Investigational Site | Pietra Ligure (SV) | |
| Italy | 1268.16.39001 Boehringer Ingelheim Investigational Site | Pisa | |
| Korea, Republic of | 1268.16.82008 Boehringer Ingelheim Investigational Site | Anyang | |
| Korea, Republic of | 1268.16.82009 Boehringer Ingelheim Investigational Site | Bucheon | |
| Korea, Republic of | 1268.16.82007 Boehringer Ingelheim Investigational Site | Cheongju | |
| Korea, Republic of | 1268.16.82006 Boehringer Ingelheim Investigational Site | Daegu | |
| Korea, Republic of | 1268.16.82010 Boehringer Ingelheim Investigational Site | Gwangju | |
| Korea, Republic of | 1268.16.82001 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1268.16.82002 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1268.16.82004 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1268.16.82005 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1268.16.82003 Boehringer Ingelheim Investigational Site | Suwon | |
| New Zealand | 1268.16.64001 Boehringer Ingelheim Investigational Site | Christchurch NZ | |
| New Zealand | 1268.16.64003 Boehringer Ingelheim Investigational Site | Greenlane East Auckland | |
| Sweden | 1268.16.46002 Boehringer Ingelheim Investigational Site | Göteborg | |
| Sweden | 1268.16.46001 Boehringer Ingelheim Investigational Site | Lund | |
| Sweden | 1268.16.46003 Boehringer Ingelheim Investigational Site | Örebro | |
| Turkey | 1268.16.90002 Boehringer Ingelheim Investigational Site | Bursa | |
| Turkey | 1268.16.90003 Boehringer Ingelheim Investigational Site | Istanbul | |
| Turkey | 1268.16.90004 Boehringer Ingelheim Investigational Site | Istanbul | |
| Turkey | 1268.16.90006 Boehringer Ingelheim Investigational Site | Istanbul | |
| Turkey | 1268.16.90001 Boehringer Ingelheim Investigational Site | Mersin | |
| United Kingdom | 1268.16.44005 Boehringer Ingelheim Investigational Site | Chertsey | |
| United Kingdom | 1268.16.44004 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1268.16.44002 Boehringer Ingelheim Investigational Site | Manchester | |
| United Kingdom | 1268.16.44003 Boehringer Ingelheim Investigational Site | Southampton | |
| United States | 1268.16.01002 Boehringer Ingelheim Investigational Site | Charleston | South Carolina |
| United States | 1268.16.01004 Boehringer Ingelheim Investigational Site | Denver | Colorado |
| United States | 1268.16.01005 Boehringer Ingelheim Investigational Site | El Paso | Texas |
| United States | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Austria, Germany, Italy, Korea, Republic of, New Zealand, Sweden, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit.
MMRM in the statistical test comments is Mixed effects model with repeated measures. |
Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment. | |
| Secondary | Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment | Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment.
The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of Short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted. |
Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment. |
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