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)
NCT00807053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480
Last updated 2016-12-05
Summary
The primary objective of this study is to demonstrate the efficacy of ciclesonide HFA, applied as a nasal aerosol once daily, in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.
Conditions
- Rhinitis, Allergic, Seasonal
Interventions
- DRUG
-
Ciclesonide HFA
75 mcg Ciclesonide HFA versus Placebo
- DRUG
-
Ciclesonide HFA
150 mcg Ciclesonide HFA versus Placebo
- DRUG
-
Ciclesonide HFA
300 mcg Ciclesonide HFA versus Placebo
- DRUG
-
Placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AstraZeneca AstraZeneca · AstraZeneca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-04-30
- Primary Completion
- 2007-06-30
- Completion
- 2007-07-31
Countries
- United States
Study Locations
More Related Trials
-
Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
NCT00305487 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
NCT00384475 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)
NCT01458275 ·Status: COMPLETED ·Phase: PHASE3
-
Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-407)
NCT00659503 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
NCT00163514 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR
NCT00854360 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)
NCT00163488 ·Status: COMPLETED ·Phase: PHASE3
-
To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)
NCT00658918 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
NCT00261287 ·Status: COMPLETED ·Phase: PHASE3
-
Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients With Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)
NCT00659048 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis
NCT01033825 ·Status: COMPLETED ·Phase: PHASE3
-
Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
NCT01024608 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).
NCT01451541 ·Status: COMPLETED ·Phase: PHASE3
-
A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
NCT01067105 ·Status: COMPLETED ·Phase: PHASE3
-
Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406)
NCT00659594 ·Status: COMPLETED ·Phase: PHASE3
-
Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490)
NCT00806754 ·Status: COMPLETED ·Phase: PHASE4
-
A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
NCT00953147 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis
NCT01378429 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia
NCT02155881 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis
NCT01287364 ·Status: COMPLETED ·Phase: PHASE3
-
Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray
NCT01401465 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848
NCT01185080 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy, Safety & Tolerability of Ciclesonide 200mcg Spray 4 Weeks Treatment for Intermittent & Persistent Rhinitis
NCT01369563 ·Status: COMPLETED
-
Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
NCT00458835 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies
NCT01368445 ·Status: COMPLETED ·Phase: PHASE3