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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392288
• Other study ID #: EFC6695
• Secondary ID: XRP1526
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2006
• Last updated: May 4, 2012
• Start date: September 2006
• Est. completion date: February 2008

Study information

• Verified date: May 2012
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: Ministry of HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide
Ciclesonide MDI 40 µg BID over twelve weeks
• Ciclesonide
Ciclesonide MDI 80 µg BID over twelve weeks
• Placebo
Placebo MDI over twelve weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Nycomed	Sanofi

Countries where clinical trial is conducted

United States,  Hungary,  Mexico,  Poland,  Russian Federation,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No

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