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Ciclesonide HFA

Phase 2

Rhinitis, Allergic, Seasonal | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Dec 5, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment480

FDA Designations

No designations recorded

Clinical trial landscape

Ciclesonide HFA · 1 trial · 1 indication

Phase 2 1
NCT00807053Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)Rhinitis, Allergic, Seasonal
COMPLETED480 Analytics
PHASE2COMPLETED
Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)
Rhinitis, Allergic, Seasonal
NCT00807053480
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Study Endpoints

Primary Endpoints

Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment
2 weeks

Secondary Endpoints

Average of AM and PM patient-reported instantaneous TNSS over the first two weeks of treatment
2 weeks
Physician-assessed total nasal symptoms score (PNSS) over the treatment period
4 weeks
Rhinoconjunctivitis Quality of Life Questionaire (RQLQ) over the treatment period in patients (adolescents and adults) with impaired quality of life at Baseline defined as a RQLQ score of greater than 3.0
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORCiclesonide HFA 75 mcg (37,5 mcg / actuation, 1 actuation/nostril), once daily
2ACTIVE_COMPARATORCiclesonide HFA 150 mcg (75 mcg / actuation, 1 actuation/nostril), once daily
3ACTIVE_COMPARATORCiclesonide HFA 300 mcg (150 mcg / actuation, 1 actuation/nostril), once daily
4PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
Ciclesonide HFADRUG75 mcg Ciclesonide HFA versus Placebo
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: 1. Male or female 12 years and older 2. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct,influence the interpretation of study observations/results, or put the patient at increases risk during the trial 3. A history...

Countries:United States
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Frequently asked questions about Ciclesonide HFA

What is Ciclesonide HFA used for in seasonal allergic rhinitis?

Ciclesonide HFA is an investigational small molecule being studied for the treatment of seasonal allergic rhinitis (SAR) in adult and adolescent patients 12 years and older. It is administered as a nasal aerosol and is currently in Phase 2 clinical development.

What does Ciclesonide HFA target?

Ciclesonide HFA is a corticosteroid that works locally in the nasal passages to reduce inflammation associated with allergic rhinitis. It is being evaluated for its efficacy and safety in treating symptoms of seasonal allergic rhinitis.

Who makes Ciclesonide HFA?

Ciclesonide HFA is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to assess the drug's potential in treating seasonal allergic rhinitis.

What phase is Ciclesonide HFA in?

Ciclesonide HFA is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A completed Phase 2 trial has evaluated its efficacy and safety in patients with seasonal allergic rhinitis.

What clinical trials is Ciclesonide HFA in?

Ciclesonide HFA has one completed clinical trial, identified as NCT00807053. This was a dose-ranging, randomized, double-blind, placebo-controlled study that enrolled 480 participants aged 12 years and older with seasonal allergic rhinitis in the United States.

Is Ciclesonide HFA the same as ciclesonide?

Ciclesonide HFA is a formulation of ciclesonide delivered as a hydrofluoroalkane (HFA) nasal aerosol. It is being studied specifically for seasonal allergic rhinitis, and the HFA formulation distinguishes it from other delivery forms of ciclesonide.