- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01007721
Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season
Randomised, Double-blind, Triple Dummy, Partial Cross-over (Each Active Treatment With Placebo) Study Using an Environmental Challenge Chamber (ECC) to Assess the Safety and Efficacy of 2 Weeks of Oral BI 671800 ED 50, 200 or 400 mg Bid, Compared to Montelukast 10 mg qd, Fluticasone Propionate Nasal Spray 200 µg qd (2 Nasal Actuations Each Nostril of 50 µg) Versus Placebo in Seasonal Allergic Rhinitis Patients Out of Season, Sensitive to Dactylis Glomerata.
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: BI 67100 ED 25 mg
- Drug: BI 671800 ED placebo
- Drug: montelukast placebo tablet
- Drug: fluticasone propionate placebo nasal spray
- Drug: BI 671800 ED placebo
- Drug: BI 671800 ED 100 mg
- Drug: BI 671800 ED 100 mg
- Drug: 671800 ED placebo
- Drug: montelukast 10 mg tablet
- Drug: Fluticasonepropionate nasal spray 200 mcg
- Drug: fluticasone propionate nasal spray placebo
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Hannover, Germany
- 1268.41.49001 Boehringer Ingelheim Investigational Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent consistent with ICH-GCP guidelines (International Conference on Harmonisation for Good Clinical Practice) and local legislations prior to any study-related procedures, which includes medication washout and restrictions.
- Male or female, with a diagnosis of seasonal allergic rhinitis by a physician with a positive skin prick test to Dactylis glomerata within 12 months prior to Visit 2
- TNSS (total nasal symptom score) of less or equal than 2 before start of challenge at Visit 2 and a TNSS of > 5 at least once during the 2h-baseline ECC exposure
- 18 to 65 years of age (age inclusive)
- Non-smoker or ex-smoker with a cigarette smoking history of less or equal than 10 pack-years (and smoking cessation for at least one year prior to enrolment) with negative urinary cotinine at screening (Visit 1)
- Ability to comply with requirements, medication restrictions (see 4.2.2) and procedures of the study protocol including AM1® device and rescue medication use.
- Pre-bronchodilator FEV1 (forced expiratory volume in one second) equal or greater than 80% of predicted value (European Community for Steel and Coal) at screening
- BMI between 18 and 35 (Body Mass Index)
- Negative breath -alcohol, urine -cotinine and -drug tests at screening (Visit 1)
Exclusion Criteria:
Significant pulmonary disease other than allergic rhinitis (or mild intermittent asthma managed by SABA (short acting bronchodilator) alone) or other medical conditions* that may, in the opinion of the investigator result in the any of the following:
- put the patient at risk because of participation in the study
- influence the results of the study (as determined by medical history, examination and clinical investigations at screening)
- cause concern regarding the patient's ability to participate in the study. *e.g. cardiac, gastro-intestinal, hepatic, renal, metabolic, dermatologic, neurological, haematological, oncological and psychiatric. Patients with malignancy for which the patient has undergone resection, radiation or chemotherapy within past 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed.
- Any other nasal and sinusoidal diseases or conditions by discretion of the investigator (i.e. nasal polyps, frequent nose bleeding) which may influence the study results
- Respiratory tract infection or asthma exacerbation in the 4 weeks prior to Visit 1 or during the screening and baseline period.
- Thoracotomy with pulmonary resection.
- Previous participation in this study (receipt of randomized treatment) or active participation in a current interventional study.
- Patients with a clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis at screening, if the abnormality defines a significant disease as defined in exclusion criterion No. 1. Patients will not be randomised if they have increased liver transaminases (AST or ALT greater than two fold the upper limit of normal at screening). Laboratory testing may be repeated once before randomization.
- Significant alcohol or drug abuse within past 2 years (see exclusion criteria No. 1)
- Patients with known hypersensitivity to any component of the investigational treatment (see section 4.1.1) or to fluticasone propionate nasal spray or montelukast or salbutamol or components.
- Patients taking CYP2C8 substrates such as -but not restricted to- amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone, and repaglinide and CYP2C9 substrates such as -but not restricted to- warfarin, tolbutamide, phenytoin, losartan and acenocoumarol.
Patients who have been treated with any of the following medications in the given interval before the respective Visit: Before Visit 2
- An investigational drug within 1 month or six half lives (whichever is greater)
- Any immunomodulatory therapy since specific positive skin prick test.
- A biological based antagonist therapy including Omalizumab, or immune modulator therapy within 6 months
- A systemic (intravenous, intramuscular or oral) corticosteroid within 3 months
- The following medications within 4 weeks: topical steroids, change in prescription medications
- The following medications within 2 weeks: LABA (long acting beta agonist), methylxanthines, leukotriene modifiers, any antihistamines, oral decongestants, any anti-rhinitis therapies (i.e., decongestants, herbals, anticholinergics), and hay-fever medications, tricyclic antidepressants, aspirin and any NSAIDs (non steroidal anti inflammatory drugs) (for occasional pain relief, only paracetamol may be used), oral beta 2 agonists
- Before Visit 1: Short acting bronchodilator within 6 hours of baseline pulmonary function testing
Patients with a risk for prolonged QT interval effects including:
- A marked baseline prolongation of the QT interval in the electrocardiogram by demonstration of a QTcB interval (Bazett's correction formula) > 450 ms
- A history of additional risk factors for TdP (Torsades de pointes) e.g., heart failure, hypokalemia, family, history of Long QT Syndrome, etc.
- The use of concomitant medications known to prolong the QT/QTc interval
- Pregnant or nursing women
- Women of childbearing potential not using a highly effective method of birth control.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 671800 ED 100 mg
2 capsules of BI 671800 ED 25 mg plus 2 capsules of BI 671800 ED placebo (bid in the morning and evening) plus 1 over-encapsulated montelukast placebo tablet (qd in the morning) plus fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
|
2 capsules of BI 671800 ED 25 mg
2 capsules of BI 671800 ED placebo (bid in the morning and evening)
1 over-encapsulated montelukast placebo tablet (qd in the morning)
fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
4 capsules of BI 671800 ED placebo (bid in the morning and evening)
|
Experimental: BI 671800 ED 400 mg
2 capsules of BI 671800 ED 100 mg plus 2 capsules of placebo (bid in the morning and evening) plus 1 over-encapsulated montelukast placebo tablet (qd in the morning) plus fluticasone propionate nasal spray placebo (2 puffs each nostril qd in the morning)
|
1 over-encapsulated montelukast placebo tablet (qd in the morning)
fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
4 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
2 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
2 capsules of BI 671800 ED placebo (bid in the morning and evening)
|
Active Comparator: Montelukast 10 mg
1 over-encapsulated montelukast 10 mg tablet (qd in the morning) plus 4 capsules of BI 671800 ED placebo (bid in the morning and evening) plus fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
|
2 capsules of BI 671800 ED placebo (bid in the morning and evening)
fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
4 capsules of BI 671800 ED placebo (bid in the morning and evening)
1 over-encapsulated montelukast 10 mg tablet (qd in the morning)
|
Active Comparator: Fluticasonepropionate nasal spray 200¿g
Fluticasonepropionate nasal spray 200 mcg (qd, 2 puffs of 50 ¿g per nostril) plus 4 capsules of BI 671800 ED placebo (bid in the morning and evening) plus 1 overencapsulated montelukast placebo tablet (qd in the morning)
|
2 capsules of BI 671800 ED placebo (bid in the morning and evening)
1 over-encapsulated montelukast placebo tablet (qd in the morning)
4 capsules of BI 671800 ED placebo (bid in the morning and evening)
Fluticasonepropionate nasal spray 200 mcg (qd, 2 puffs of 50 mcg per nostril)
|
Placebo Comparator: BI 671800 ED placebo
4 capsules of BI 671800 ED placebo (bid in the morning and evening), plus 1 over-encapsulated montelukast placebo tablet (qd in the morning) plus fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
|
2 capsules of BI 671800 ED placebo (bid in the morning and evening)
1 over-encapsulated montelukast placebo tablet (qd in the morning)
fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
4 capsules of BI 671800 ED placebo (bid in the morning and evening)
|
Experimental: BI 671800 ED 800 mg
4 capsules of BI 671800 ED 100 mg (bid in the morning and evening) plus 1 over-encapsulated montelukast placebo tablet (qd in the morning) plus fluticasone propionate nasal spray placebo (2 puffs each nostril qd in the morning)
|
1 over-encapsulated montelukast placebo tablet (qd in the morning)
4 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
2 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
fluticasone propionate nasal spray placebo (2 puffs each nostril qd in the morning)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Nasal Symptom Score (TNSS) as AUC (area under the curve) of values over the entire period from 0-6 hours (h) in the ECC (Environmental Challenge Chamber)
Time Frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
|
After 2 wks of active treatment compared to 2 wks treatment with placebo
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Symptom Score (TSSc) as AUC of values for the following periods: 0-2h; 2-4h; 4-6h; 2-6h; 0-6h; 0h-tmax; tmax-6h and hourly
Time Frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
|
After 2 wks of active treatment compared to 2 wks treatment with placebo
|
TNSS as AUC of values for the following periods: 0-2h; 2-4h; 4-6h; 2-6; 0h-tmax; tmax-6h and hourly
Time Frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
|
After 2 wks of active treatment compared to 2 wks treatment with placebo
|
Total Ocular Symptom Score (TOSS) as AUC of values for the following periods: 0-2h; 2-4h; 4-6h; 2-6h; 0-6h; 0h-tmax; tmax- 6h and hourly
Time Frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
|
After 2 wks of active treatment compared to 2 wks treatment with placebo
|
Nasal and ocular sub-scores (single symptoms of TNSS and TOSS) as AUC of values for the following periods: 0-2h; 2-4h; 4-6h; 2-6h; 0-6h; 0h-tmax; tmax-6h and hourly
Time Frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
|
After 2 wks of active treatment compared to 2 wks treatment with placebo
|
Flow rate from rhinomanometry as AUC of values obtained at 2, 4 and 6 h
Time Frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
|
After 2 wks of active treatment compared to 2 wks treatment with placebo
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Anti-Allergic Agents
- Montelukast
- Fluticasone
- Xhance
Other Study ID Numbers
- 1268.41
- 2009-013269-24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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