Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.

A Multicenter, Multi-national, Randomized, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Ciclesonide Metered-dose Inhaler (MDI) at 80 μg BID or 40 μg BID for 12 Weeks in Patients Aged 4 to <12 Years With Persistent Asthma.

Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.

Secondary objective: To assess the safety and tolerability of ciclesonide.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Ciclesonide; Drug: Ciclesonide

• Study Type: Interventional
• Enrollment (Actual): 528
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • sanofi-aventis Hungaria
• Mexico
  • Mexico, Mexico
    • Sanofi-Aventis
• Poland
  • Warszawa, Poland
    • sanofi-aventis Poland
• Russian Federation
  • Moscow, Russian Federation
    • Sanofi-Aventis Administrative Office
• South Africa
  • Midrand, South Africa
    • sanofi-aventis South Africa
• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • sanofi-aventis, US

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• History of persistent bronchial asthma for at least 3 months prior to screening;
• For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;
• For patients with persistent bronchial asthma and not being treated with controller therapy: Patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
• Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
• Only patients aged between 6 to <12 years must have a forced expiratory volume in one second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol

Exclusion Criteria:

• Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
• Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
• Upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
• History of life-threatening asthma, including a history of significant hypercarbia (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
• More than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
• Use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo MDI; double-blind	Drug: Placebo; Placebo MDI over twelve weeks
Experimental: Ciclesonide MDI 40 µg BID; double-blind	Drug: Ciclesonide; Ciclesonide MDI 40 µg BID over twelve weeks; Drug: Ciclesonide; Ciclesonide MDI 80 µg BID over twelve weeks
Experimental: Ciclesonide MDI 80 µg BID; double-blind	Drug: Ciclesonide; Ciclesonide MDI 40 µg BID over twelve weeks; Drug: Ciclesonide; Ciclesonide MDI 80 µg BID over twelve weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.	Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Daily Asthma Symptom Score at Week 12.	Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep)	Baseline and Week 12
Change From Baseline in Use of Albuterol/Salbutamol at Week 12.	Change in albuterol/salbutamol use from baseline to week 12	Baseline and Week 12

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: October 24, 2006
• First Submitted That Met QC Criteria: October 24, 2006
• First Posted (Estimate): October 25, 2006

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Bronchial Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Ciclesonide
• Other Study ID Numbers: EFC6695; XRP1526