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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00392288

Run by

AstraZeneca

People needed

528

Starts

2006-09-01

Expected to finish

2008-02-01

Last updated by the study team

2017-02-01

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• 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

Full record on ClinicalTrials.gov

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