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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Ciclesonide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00392288

EFC6695

XRP1526

Details and patient eligibility

About

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.

Enrollment: 528 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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528 participants in 3 patient groups, including a placebo group

Placebo MDI

Placebo Comparator group

Description:

double-blind

Treatment:

Drug: Placebo

Ciclesonide MDI 40 µg BID

Experimental group

Description:

double-blind

Treatment:

Drug: Ciclesonide

Drug: Ciclesonide

Ciclesonide MDI 80 µg BID

Experimental group

Description:

double-blind

Treatment:

Drug: Ciclesonide

Drug: Ciclesonide