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

NCT ID: NCT00392288

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 528 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-02-29

Brief Summary

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo MDI

double-blind

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo MDI over twelve weeks

Ciclesonide MDI 40 µg BID

double-blind

Group Type: EXPERIMENTAL

Ciclesonide

Intervention Type: DRUG

Ciclesonide MDI 40 µg BID over twelve weeks

Ciclesonide MDI 80 µg BID

double-blind

Group Type: EXPERIMENTAL

Ciclesonide

Intervention Type: DRUG

Ciclesonide MDI 80 µg BID over twelve weeks

Interventions

Ciclesonide

Ciclesonide MDI 40 µg BID over twelve weeks

Intervention Type: DRUG

Ciclesonide

Ciclesonide MDI 80 µg BID over twelve weeks

Intervention Type: DRUG

Placebo

Placebo MDI over twelve weeks

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

sanofi-aventis, US

Bridgewater, New Jersey, United States

Sanofi-Aventis Hungaria

Budapest, , Hungary

Sanofi-Aventis

México, , Mexico

sanofi-aventis Poland

Warsaw, , Poland

Sanofi-Aventis Administrative Office

Moscow, , Russia

sanofi-aventis South Africa

Midrand, , South Africa

Countries

United States; Hungary; Mexico; Poland; Russia; South Africa

Other Identifiers

XRP1526

Identifier Type: -

Identifier Source: secondary_id

EFC6695

Identifier Type: -

Identifier Source: org_study_id