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Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101) (POPCICLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00163293
First received: September 12, 2005
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.

Condition Intervention Phase
Asthma Drug: Ciclesonide Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to First Asthma Exacerbation [ Time Frame: Up to 12 months ]
    Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug.

  • Exacerbations (Post-hoc Analysis of Annual Rates) [ Time Frame: Up to 12 months ]
    A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age [years] and race were identified to be important beside treatment. The parameters centre and age [years] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.


Secondary Outcome Measures:
  • Growth Velocity as Assessed by Stadiometric Height Measurement [ Time Frame: Up to 12 months ]
    Standing height measured in millimeters (mm) with a wall-mounted stadiometer.

  • Mean Rate of Asthma Exacerbations Per Year [ Time Frame: Up to 12 months ]
    Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year).

  • Duration of Exacerbations [ Time Frame: Up to 12 months ]
    Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline.

  • Number of Exacerbations Per Participant [ Time Frame: Up to 12 months ]
    The mean number of asthma exacerbations per participant is reported.

  • Percentage of Participants Who Dropped-out Due to Asthma Exacerbation [ Time Frame: Up to 12 months ]
  • Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) [ Time Frame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12 ]
    FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.

  • Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) [ Time Frame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12 ]
    FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.

  • Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries [ Time Frame: Months 1, 2, 4, 6, 8, 10 and 12 ]
    PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF.

  • Change From Baseline in PEF by Diary Entries [ Time Frame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12 ]
    PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement.

  • Change From Baseline in Diurnal PEF Fluctuation [ Time Frame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12 ]
    Diurnal PEF Fluctuation is equal to [(Higher PEF - Lower PEF)/0.5*(Higher PEF + Lower PEF)] * 100%. A positive change from Baseline indicates improvement.

  • Total Asthma Symptom Score by Diary Entries [ Time Frame: Months 1, 2, 4, 6, 8, 10 and 12 ]
    Total Asthma Score = daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0= Very well, no symptoms, 1= One episode of wheezing, cough or breathlessness, 2= More than one episode of wheezing, cough or breathlessness without interfering with normal activities, 3= Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4= Asthma very bad. Unable to carry out daily activities as usual.

  • Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms [ Time Frame: Months 1, 2, 4, 6, 8, 10 and 12 ]
    Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary.

  • Rescue Medication Use Per Day [ Time Frame: Months 1, 2, 4, 6, 8, 10 and 12 ]
    Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant's diary.

  • Percentage of Rescue Medication Free Days [ Time Frame: Months 1, 2, 4, 6, 8, 10 and 12 ]
    Days without use of rescue medication documented in the participant's diary were reported.

  • Percentage of Asthma Symptom Free Days [ Time Frame: Months 1, 2, 4, 6, 8, 10 and 12 ]
    Days without Asthma Symptom documented in the participant's diary were reported.

  • Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) [ Time Frame: Months 2, 6 and 12 ]
    The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where "1" indicated maximum impairment and "7" indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best).

  • Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) [ Time Frame: Months 2, 6 and 12 ]
    The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby "1" indicated maximum impairment and "7" indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best).

  • Number of Participants With Clinically Significant Vital Signs Findings [ Time Frame: Up to 12 months ]
    Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure >130 mmHg or <80 mmHg or a >20 mmHg difference from Baseline; Diastolic Blood Pressure > 85 mmHg; and Resting Heart Rate >140 bpm or <60 bpm or a >30 bpm difference from Baseline.

  • Number of Participants With Clinically Significant Physical Examination Findings [ Time Frame: Up to 12 months ]
    A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant.

  • Number of Participants With Clinically Significant Laboratory Values [ Time Frame: Up to 12 months ]
    Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin <9.5 g/dL; Erythrocytes <3.0 x 10^6/μL or >6.5 x 10^6/μL; White Blood Count <3000/mm^3 or >20000/mm^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose >2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase >3 times ULNR; Creatinine >1.5 times ULN; Potassium >5.0 mmol/L or <3.0 mmol/L; and Sodium >150 mmol/L or 130 mmol/L.

  • Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Up to 12 months ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement.


Enrollment: 240
Actual Study Start Date: January 1, 2005
Study Completion Date: April 1, 2010
Primary Completion Date: June 1, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Ciclesonide placebo-matching metered-dose inhaler
Active Comparator: Ciclesonide 100 µg
Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Drug: Ciclesonide
Ciclesonide metered-dose inhaler
Other Name: Alvesco®
Active Comparator: Ciclesonide 200 µg
Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Drug: Ciclesonide
Ciclesonide metered-dose inhaler
Other Name: Alvesco®

Detailed Description:

The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat children who have mild asthma.

The study enrolled 240 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups—which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

  • Ciclesonide 100 µg
  • Ciclesonide 200 µg
  • Placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the study drug but has no active ingredient.

All participants were asked to take two puffs from a metered-dose inhaler once daily, in the evening, for up to 12 months.

This multi-center trial was conducted in Canada, Hungary and South Africa. The overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks. Participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment.

  Eligibility

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

Main Inclusion Criteria:

  • Outpatients
  • Symptoms consistent with the diagnosis of asthma for at least 12 months
  • Forced Expiratory Volume in one Second (FEV) at least 80% of predicted
  • Participants who have a history of reversible airway obstruction
  • Good health with the exception of asthma

Main Exclusion Criteria:

  • History of life-threatening asthma
  • A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year
  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • Participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema)
  • Prematurely born children (<36 weeks of gestation)
  • Smokers
  • Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163293

Locations
Canada
Altana Pharma/Nycomed
Calgary, Canada, T2T5C7
Altana Pharma/Nycomed
Fleurimont, Canada, J1H 5M4
Altana Pharma/Nycomed
London,ON, Canada, N6A1V2
Altana Pharma/Nycomed
London, Canada, N6C 4Y7
Altana Pharma/Nycomed
Winnipeg, Canada, R3A1R9
Hungary
Altana Pharma/Nycomed
Budapest, Hungary
South Africa
Altana Pharma/Nycomed
Kapstadt, South Africa
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163293     History of Changes
Other Study ID Numbers: BY9010/CA-101
2007-003736-34 ( EudraCT Number )
U1111-1189-7814 ( Registry Identifier: WHO )
Study First Received: September 12, 2005
Results First Received: December 1, 2010
Last Updated: March 27, 2017

Keywords provided by AstraZeneca:
Asthma
Ciclesonide
Exacerbation

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 23, 2017