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NCT01880840
Randomized Trial of the Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With Allergic Rhinitis
Phase 4 trial testing 205.5 mcg of azelastine hydrochloride in Allergic Rhinitis in 191 participants. Completed in 1 August 2014.
1 April 2014
Quick facts
| Lead sponsor | Meda Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 191 |
| Start date | 1 June 2013 |
| Primary completion | 1 April 2014 |
| Estimated completion | 1 August 2014 |
| Sites | 14 locations across United States |
Drugs / interventions tested
- 205.5 mcg of azelastine hydrochloride — full drug profile →
- 137 mcg of azelastine hydrochloride — full drug profile →
Conditions studied
- Allergic Rhinitis — all drugs for Allergic Rhinitis →
Sponsor
Meda Pharmaceuticals — full company profile →
Who can join
Adults 6 Months to 5, any sex, with Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Safety
Time frame: one month of treatment
The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to \<6 years of age with allergic rhinitis. Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments. Data for each age stra
Sponsor's own description
The purpose of this study is to compare the safety of 2 different doses of the investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of allergic rhinitis (AR). This is an open-label study; that is, parent and child will know which group each is in.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01880840
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Allergic Rhinitis
Currently open trials in the same condition.
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- NCT07455968 — Free Diving Breathing Training in Allergic Rhinitis · NA · active not recruiting
- NCT07115342 — Effect of Combined Probiotics and Vitamin D on Symptoms of Allergic Rhinitis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01880840 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Meda Pharmaceuticals
- Last refreshed: 9 June 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01880840.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing