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Comparison of daily mometasone furoate nasal spray alone versus a combination with montelukast for treatment of chronic rhinosinusitis with asthma after functional endoscopic sinus surgery: a 9-month randomized, open-label, controlled study

Comparison of daily mometasone furoate nasal spray alone versus a combination with montelukast for treatment of chronic rhinosinusitis with asthma after functional endoscopic sinus surgery: a 9-month randomized, open-label, controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004375
Enrollment
Unknown
Registered
2014-03-11
Start date
2014-06-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

chronic rhinisinusitis with asthma

Interventions

1:Montelukast (10mg, once daily) for 6 months
2:mometasone furoate nasal spray (200ug, once daily) for 6 months

Sponsors

The First Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 to 70 years old, male or female, born and lived in China to date; (2) Rhinosinusitis is defined as: inflammation of the nose and the paranasal sinuses characterized by two or more symptoms, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), and with or without facial pain/pressure or reduction or loss smell. CRS is defined as more than 12 weeks of symptoms without complete resolution; (3) All patients with CRS must be also concomitant with physician diagnosed asthma. The level of asthma control status should be partly controlled or controlled according to GINA 2012 guideline; (4) All patients should provide informed consent prior to the study and agree to follow-up appointments.

Exclusion criteria

Exclusion criteria: (1) Immunodeficiency diseases, history of head and/or facial trauma, cancer or organ transplant recipients; (2) Pregnancy or lactation; (3) Uncontrolled bronchial asthma; (4) Acute respiratory tract infection within one month before the study; (5) Use of leukotriene receptor antagonist within 3 months before the enrollment.

Design outcomes

Primary

MeasureTime frame
nasal symptoms visual analog scale (VAS) scores;nasal symptoms visual analog scale (VAS) score;

Secondary

MeasureTime frame
nasal endoscopy score (Lund-Kennedy score);

Countries

China

Contacts

Public ContactJianbo Shi

The First Affiliated Hospital, Sun Yat-sen University

13808884437@163.com+86 13808884437

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026