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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392288
Recruitment Status : Completed
First Posted : October 25, 2006
Results First Posted : December 30, 2009
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide

Arm Intervention/treatment
Placebo Comparator: Placebo MDI
double-blind
Drug: Placebo
Placebo MDI over twelve weeks

Experimental: Ciclesonide MDI 40 µg BID
double-blind
Drug: Ciclesonide
Ciclesonide MDI 40 µg BID over twelve weeks

Experimental: Ciclesonide MDI 80 µg BID
double-blind
Drug: Ciclesonide
Ciclesonide MDI 80 µg BID over twelve weeks




Primary Outcome Measures :
  1. Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12. [ Time Frame: Baseline and 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.


Secondary Outcome Measures :
  1. Change From Baseline in Total Daily Asthma Symptom Score at Week 12. [ Time Frame: Baseline and 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)

  2. Change From Baseline in Use of Albuterol/Salbutamol at Week 12. [ Time Frame: Baseline and Week 12 ]
    Change in albuterol/salbutamol use from baseline to week 12



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392288


Locations
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United States, New Jersey
sanofi-aventis, US
Bridgewater, New Jersey, United States, 08807
Hungary
Sanofi-Aventis Hungaria
Budapest, Hungary
Mexico
Sanofi-Aventis
Mexico, Mexico
Poland
sanofi-aventis Poland
Warszawa, Poland
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
South Africa
sanofi-aventis South Africa
Midrand, South Africa
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca AstraZeneca AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00392288    
Other Study ID Numbers: EFC6695
XRP1526
First Posted: October 25, 2006    Key Record Dates
Results First Posted: December 30, 2009
Last Update Posted: February 1, 2017
Last Verified: September 2016
Keywords provided by AstraZeneca:
Bronchial Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents