# 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

> **NCT01007721** · PHASE2 · COMPLETED · sponsor: **Boehringer Ingelheim** · enrollment: 146 (actual)

## Conditions studied

- Rhinitis, Allergic, Seasonal
- Asthma

## Interventions

- **DRUG:** BI 67100 ED 25 mg
- **DRUG:** BI 671800 ED placebo
- **DRUG:** montelukast placebo tablet
- **DRUG:** montelukast placebo tablet
- **DRUG:** fluticasone propionate placebo nasal spray
- **DRUG:** fluticasone propionate placebo nasal spray
- **DRUG:** fluticasone propionate placebo nasal spray
- **DRUG:** BI 671800 ED 100 mg
- **DRUG:** BI 671800 ED placebo
- **DRUG:** BI 671800 ED placebo
- **DRUG:** BI 671800 ED placebo
- **DRUG:** BI 671800 ED 100 mg
- **DRUG:** 671800 ED placebo
- **DRUG:** montelukast placebo tablet
- **DRUG:** montelukast placebo tablet
- **DRUG:** montelukast placebo tablet
- **DRUG:** montelukast 10 mg tablet
- **DRUG:** fluticasone propionate placebo nasal spray
- **DRUG:** fluticasone propionate nasal spray placebo
- **DRUG:** Fluticasonepropionate nasal spray 200 mcg

## Key facts

- **NCT ID:** NCT01007721
- **Lead sponsor:** Boehringer Ingelheim
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-10
- **Primary completion:** 2010-04
- **Final completion:** —
- **Target enrollment:** 146 (ACTUAL)
- **Last updated:** 2014-05-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01007721

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT01007721. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*