CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 188 enrolled
Drug / intervention
Mometasone +2 moredrug
Likely dose
Mometasone nasal spray 200 mcg/day (2 sprays of 50 mcg per spray in each nostril)AI-extracted
Key inclusion· 3
  • ✓At least 2-year history of seasonal allergic rhinitis with increased asthma symptoms during allergy season
  • ✓Positive skin prick test (wheal ≥3 mm larger than control) or intradermal test (wheal ≥7 mm larger than control) to seasonal allergen within 12 months
  • ✓Reversible airway obstruction: FEV1 increase of 200-1199 mL (less than 12%) post-bronchodilator within past 12 months
Key exclusion· 14
  • ✕Chronic use of inhaled or systemic corticosteroids for asthma control
  • ✕Frequent sinusitis (≥2 episodes/year for past 2 years) or chronic purulent postnasal drip
  • ✕Recent nasal septum ulcers, nasal surgery, or nasal trauma (must be healed first)
  • ✕Rhinitis medicamentosa or COPD

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00070707
NCT00070707Phase 4Completed
CompareCT.gov

Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma

Organon and Co·interventional·Posted Oct 10, 2003·Updated Sep 5, 2024

In Brief

A Phase 4 clinical trial evaluating Mometasone, Placebo, and 1 other intervention for Rhinitis, Allergic, Seasonal and Asthma. Completed, enrolled 188 participants.

Detailed Summary

This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Allergic, Seasonal, Asthma
Countries--
CollaboratorsIntegrated Therapeutics Group

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 10, 2003
Enrollment StartApr 3, 2003
Primary CompletionNov 26, 2003
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 22.7 years ago

Interventions

Mometasonedrug

Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.

Placebodrug

Matching placebo nasal spray, administered QD as 2 sprays in each nostril.

Albuterol/Salbutamoldrug

Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.