Rhinitis, Allergic, SeasonalPhase 2NCT01007721
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
A Phase 2 study testing BI 67100 ED 25 mg and BI 671800 ED 100 mg in people with Rhinitis, Allergic, Seasonal and Asthma, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 671800 ED using three dose levels of BI 671800 ED (50 mg, 200 mg and 400 mg), administered twice daily compared to FP (fluticasone propionate) nasal 100 mcg per nostril qd in the morning or Montelukast 10 mg qd am given… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Asthma
- What is being tested?
- BI 67100 ED 25 mg and BI 671800 ED 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Apr 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
Show all 26Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 671800 ED using three dose levels of BI 671800 ED (50 mg, 200 mg and 400 mg), administered twice daily compared to FP (fluticasone propionate) nasal 100 mcg per nostril qd in the morning or Montelukast 10 mg qd am given for 2 weeks in patients with SAR (seasonal allergic rhinitis) out of season using an environmental exposure chamber in patients known to be sensitive to the aero-allergen Dactylis glomerata.
- Conditions
- Rhinitis, Allergic, Seasonal, Asthma
- Being tested
- BI 67100 ED 25 mg, BI 671800 ED placebo, montelukast placebo tablet, fluticasone propionate placebo nasal spray, BI 671800 ED 100 mg
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 67100 ED 25 mgDrug
2 capsules of BI 671800 ED 25 mg
BI 671800 ED placeboDrug
2 capsules of BI 671800 ED placebo (bid in the morning and evening)
montelukast placebo tabletDrug
1 over-encapsulated montelukast placebo tablet (qd in the morning)
montelukast placebo tabletDrug
1 over-encapsulated montelukast placebo tablet (qd in the morning)
fluticasone propionate placebo nasal sprayDrug
fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
fluticasone propionate placebo nasal sprayDrug
fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
fluticasone propionate placebo nasal sprayDrug
fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
BI 671800 ED 100 mgDrug
4 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
BI 671800 ED placeboDrug
4 capsules of BI 671800 ED placebo (bid in the morning and evening)
BI 671800 ED placeboDrug
4 capsules of BI 671800 ED placebo (bid in the morning and evening)
BI 671800 ED placeboDrug
4 capsules of BI 671800 ED placebo (bid in the morning and evening)
BI 671800 ED 100 mgDrug
2 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
671800 ED placeboDrug
2 capsules of BI 671800 ED placebo (bid in the morning and evening)
montelukast placebo tabletDrug
1 over-encapsulated montelukast placebo tablet (qd in the morning)
montelukast placebo tabletDrug
1 over-encapsulated montelukast placebo tablet (qd in the morning)
montelukast placebo tabletDrug
1 over-encapsulated montelukast placebo tablet (qd in the morning)
montelukast 10 mg tabletDrug
1 over-encapsulated montelukast 10 mg tablet (qd in the morning)
fluticasone propionate placebo nasal sprayDrug
fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
fluticasone propionate nasal spray placeboDrug
fluticasone propionate nasal spray placebo (2 puffs each nostril qd in the morning)
Fluticasonepropionate nasal spray 200 mcgDrug
Fluticasonepropionate nasal spray 200 mcg (qd, 2 puffs of 50 mcg per nostril)
| Study group | Role | What they receive |
|---|---|---|
| BI 671800 ED 100 mg | Experimental | 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) Receives: Drug: BI 67100 ED 25 mg; Drug: BI 671800 ED placebo; Drug: montelukast placebo tablet; Drug: fluticasone propionate placebo nasal spray |
| BI 671800 ED 400 mg | Experimental | 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) Receives: Drug: fluticasone propionate placebo nasal spray; Drug: BI 671800 ED 100 mg; Drug: 671800 ED placebo; Drug: montelukast placebo tablet |
| Montelukast 10 mg | Active comparator | 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) Receives: Drug: fluticasone propionate placebo nasal spray; Drug: BI 671800 ED placebo; Drug: montelukast 10 mg tablet |
| Fluticasonepropionate nasal spray 200¿g | Active comparator | 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) Receives: Drug: BI 671800 ED placebo; Drug: montelukast placebo tablet; Drug: Fluticasonepropionate nasal spray 200 mcg |
| BI 671800 ED placebo | Placebo comparator | 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) Receives: Drug: montelukast placebo tablet; Drug: BI 671800 ED placebo; Drug: fluticasone propionate placebo nasal spray |
| BI 671800 ED 800 mg | Experimental | 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) Receives: Drug: BI 671800 ED 100 mg; Drug: montelukast placebo tablet; Drug: fluticasone propionate nasal spray placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: After 2 wks of active treatment compared to 2 wks treatment with placebo
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After 2 wks of active treatment compared to 2 wks treatment with placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007721
- Sponsor's protocol ID
- 1268.41
- Other IDs
- 2009-013269-24, 2009
- Status last verified
- Apr 2014
- First submitted
- 3 Nov 2009
- Last updated
- 16 May 2014
- Results posted
- No
Publications
Krug N, Gupta A, Badorrek P, Koenen R, Mueller M, Pivovarova A, Hilbert J, Wetzel K, Hohlfeld JM, Wood C. Efficacy of the oral chemoattractant receptor homologous molecule on TH2 cells antagonist BI 671800 in patients with seasonal allergic rhinitis. J Allergy Clin Immunol. 2014 Feb;133(2):414-9. doi: 10.1016/j.jaci.2013.10.013. Epub 2013 Dec 9.
PubMed 24332218
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01007721
- Acronym / sponsor ID
- 1268.41
- Conditions
- Rhinitis, Allergic, Seasonal, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 671800 ED using three dose levels of BI 671800 ED (50 mg, 200 mg and 400 mg), administered twice daily compared to FP (fluticasone propionate) nasal 100 mcg per nostril qd in the morning or Montelukast 10 mg qd am given for 2 weeks in patients with SAR (seasonal allergic rhinitis) out of season using an environmental exposure chamber in patients known to be sensitive to the aero-allergen Dactylis glomerata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BI 671800 ED 100 mg | Experimental | Drug: BI 67100 ED 25 mg, Drug: BI 671800 ED placebo, Drug: montelukast placebo tablet, Drug: fluticasone propionate placebo nasal spray2 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) |
| BI 671800 ED 400 mg | Experimental | Drug: fluticasone propionate placebo nasal spray, Drug: BI 671800 ED 100 mg, Drug: 671800 ED placebo, Drug: montelukast placebo tablet2 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) |
| Montelukast 10 mg | Active comparator | Drug: fluticasone propionate placebo nasal spray, Drug: BI 671800 ED placebo, Drug: montelukast 10 mg tablet1 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) |
| Fluticasonepropionate nasal spray 200¿g | Active comparator | Drug: BI 671800 ED placebo, Drug: montelukast placebo tablet, Drug: Fluticasonepropionate nasal spray 200 mcgFluticasonepropionate 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) |
| BI 671800 ED placebo | Placebo comparator | Drug: montelukast placebo tablet, Drug: BI 671800 ED placebo, Drug: fluticasone propionate placebo nasal spray4 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) |
| BI 671800 ED 800 mg | Experimental | Drug: BI 671800 ED 100 mg, Drug: montelukast placebo tablet, Drug: fluticasone propionate nasal spray placebo4 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (26 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 67100 ED 25 mg2 capsules of BI 671800 ED 25 mg | Drug | BI 671800 ED 100 mg |
| BI 671800 ED placebo2 capsules of BI 671800 ED placebo (bid in the morning and evening) | Drug | BI 671800 ED 100 mg |
| montelukast placebo tablet1 over-encapsulated montelukast placebo tablet (qd in the morning) | Drug | BI 671800 ED 100 mg |
| montelukast placebo tablet1 over-encapsulated montelukast placebo tablet (qd in the morning) | Drug | BI 671800 ED placebo |
| fluticasone propionate placebo nasal sprayfluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning) | Drug | BI 671800 ED 100 mg |
| fluticasone propionate placebo nasal sprayfluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning) | Drug | BI 671800 ED 400 mg |
| fluticasone propionate placebo nasal sprayfluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning) | Drug | Montelukast 10 mg |
| BI 671800 ED 100 mg4 capsules of BI 671800 ED 100 mg (bid in the morning and evening) | Drug | BI 671800 ED 800 mg |
| BI 671800 ED placebo4 capsules of BI 671800 ED placebo (bid in the morning and evening) | Drug | Montelukast 10 mg |
| BI 671800 ED placebo4 capsules of BI 671800 ED placebo (bid in the morning and evening) | Drug | BI 671800 ED placebo |
| BI 671800 ED placebo4 capsules of BI 671800 ED placebo (bid in the morning and evening) | Drug | Fluticasonepropionate nasal spray 200¿g |
| BI 671800 ED 100 mg2 capsules of BI 671800 ED 100 mg (bid in the morning and evening) | Drug | BI 671800 ED 400 mg |
| 671800 ED placebo2 capsules of BI 671800 ED placebo (bid in the morning and evening) | Drug | BI 671800 ED 400 mg |
| montelukast placebo tablet1 over-encapsulated montelukast placebo tablet (qd in the morning) | Drug | BI 671800 ED 400 mg |
| montelukast placebo tablet1 over-encapsulated montelukast placebo tablet (qd in the morning) | Drug | BI 671800 ED 800 mg |
| montelukast placebo tablet1 over-encapsulated montelukast placebo tablet (qd in the morning) | Drug | Fluticasonepropionate nasal spray 200¿g |
| montelukast 10 mg tablet1 over-encapsulated montelukast 10 mg tablet (qd in the morning) | Drug | Montelukast 10 mg |
| fluticasone propionate placebo nasal sprayfluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning) | Drug | BI 671800 ED placebo |
| fluticasone propionate nasal spray placebofluticasone propionate nasal spray placebo (2 puffs each nostril qd in the morning) | Drug | BI 671800 ED 800 mg |
| Fluticasonepropionate nasal spray 200 mcgFluticasonepropionate nasal spray 200 mcg (qd, 2 puffs of 50 mcg per nostril) | Drug | Fluticasonepropionate nasal spray 200¿g |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Derived from this study: PubMed 24332218Krug N, Gupta A, Badorrek P, Koenen R, Mueller M, Pivovarova A, Hilbert J, Wetzel K, Hohlfeld JM, Wood C. Efficacy of the oral chemoattractant receptor homologous molecule on TH2 cells antagonist BI 671800 in patients with seasonal allergic rhinitis. J Allergy Clin Immunol. 2014 Feb;133(2):414-9. doi: 10.1016/j.jaci.2013.10.013. Epub 2013 Dec 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 67100 ED 25 mg and BI 671800 ED 100 mg in people with Rhinitis, Allergic, Seasonal and Asthma, run by Boehringer Ingelheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01007721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.