Clinical trial NCT00392288: Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Bronchial Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 528
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Total Daily Asthma Symptom Score at Week 12.
timeFrame: Baseline and Week 12
measure: Change From Baseline in Use of Albuterol/Salbutamol at Week 12.
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: sanofi-aventis, US
state: New Jersey
city: Budapest
country: Hungary
facility: Sanofi-Aventis Hungaria
city: Mexico
country: Mexico
facility: Sanofi-Aventis
city: Warszawa
country: Poland
facility: sanofi-aventis Poland
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: sanofi-aventis South Africa
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: