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A Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled Trial for Effective and Safe of Bencycloquidium Bromide Nasal Spray in the treatment of Persistent Allergic Rhinitis

A Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled Trial for Effective and Safe of Bencycloquidium Bromide Nasal Spray in the treatment of Persistent Allergic Rhinitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030924
Enrollment
Unknown
Registered
2020-03-17
Start date
2012-03-08
Completion date
Unknown
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent allergic rhinitis

Interventions

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with persistent AR according to Chinese Guideline of Allergic Rhinitis; 2. All the participants had positive response (++ or above) to at least one allergen in skin prick test (SPT) using standard reagents within 12 months(wheal diameter of positive control >=3mm and wheal diameter of allergen >=3mm; wheal diameter=(the longest diameter+its vertical diameter)/2; skin index(SI)= wheal diameter of allergen/wheal diameter of positive control; +: SI2.0); 3. The average VAS for rhinorrhea should be over 5.0 during screening period; 4. Patients could understand the protocol, cooperate and complete the whole trial; 5. Patients signed informed consents; 6. Patients did not participate any other clinical trial within 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients with other nasal disease except for persistent AR, such as rhinosinusitis, nasal tumor and deviated nasal septum; 2. could not stop using antihistamines, vasoconstrictors, or glucocorticoids; 3. had experienced injuries or operations on nose or eyes in previous 3 months; 4. were allergic to anticholinergics; had a history of glaucoma, cataract, prostatitis, prostatic hypertrophy and urinary calculus; 5. in acute disease condition; had any systemic diseases; 6. pregnant or lactating; 7. Patients were also excluded if they had applied antihistamines, anti-leukotrienes, anticholinergics or Chinese herb medicine for AR within 7 days, and applied vasoconstrictors in 3 days, tricyclic antidepressant in 14 days and glucocorticoid in 30 days before screening.

Design outcomes

Primary

MeasureTime frame
visual analog scale;

Secondary

MeasureTime frame
anterior rhinoscope scoring;

Countries

China

Contacts

Public ContactLiu Shixi

West China Hospital, Sichuan University

mjmelinda@163.com+86 18980606505

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026