Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 42 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg (CHASE 3)

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: NCT02091986
Recruitment Status : Completed
First Posted : March 19, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma during 12 weeks.

Condition or disease Intervention/treatment Phase
Asthma Drug: Symbicort pMDI Other: Budesonide pMDI Phase 3

Detailed Description:
A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 882 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years With Asthma
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arm Intervention/treatment
Active Comparator: Symbicort pMDI 80/2.25 µg
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Drug: Symbicort pMDI
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily

Active Comparator: Symbicort pMDI 80/4.5µg
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Drug: Symbicort pMDI
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily

Active Comparator: Budesonide pMDI
Budesonide pMDI 80µg, 2 acuations twice daily
Other: Budesonide pMDI
Budesonide pMDI 80µg, 2 acuations twice daily
Other Name: Active comparator




Primary Outcome Measures :
  1. Change From Baseline to Week 12 in 1h Post-dose FEV1 [ Time Frame: Week 0 (baseline), Week 12 ]
    1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).


Secondary Outcome Measures :
  1. Change From Baseline to Week 12 in 1h Post-dose PEF [ Time Frame: Week 0 (baseline), Week 12 ]
    1h post-dose PEF is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).

  2. Change From Baseline to Week 12 in 1h Post-dose FEF25-75 [ Time Frame: Week 0 (baseline), Week 12 ]
    1h post-dose FEF25-75 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).

  3. Change From Baseline to Week 12 in 1h Post-dose FVC [ Time Frame: Week 0 (baseline), Week 12 ]
    1h post-dose FVC is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).

  4. Change From Baseline to Week 12 in Pre-dose FEV1 [ Time Frame: Week 0 (baseline), Week 12 ]
    Pre-dose FEV1 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).

  5. Change From Baseline to Week 12 in Pre-dose PEF [ Time Frame: Week 0 (baseline), Week 12 ]
    Pre-dose PEF is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).

  6. Change From Baseline to Week 12 in Pre-dose FEF25-75 [ Time Frame: Week 0 (baseline), Week 12 ]
    Pre-dose FEF25-75 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).

  7. Change From Baseline to Week 12 in Pre-dose FVC [ Time Frame: Week 0 (baseline), Week 12 ]
    Pre-dose FVC is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).

  8. Change From Baseline to Week 12 in 15 Min Post-dose FEV1 [ Time Frame: Week 0 (baseline), Week 12 ]
    15 min Post-dose FEV1 is defined as the 15 min post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).

  9. Change From Baseline to End of Study Average in Total Asthma Symptoms [ Time Frame: Week 0 (baseline), Week 12 ]

    End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).

    Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma

    1. = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated
    2. = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep
    3. = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep

    Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6).


  10. Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms [ Time Frame: Week 0 (baseline), Week 12 ]
    End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).

  11. Change From Baseline to End of Study Average in Total Daily Reliever Medication [ Time Frame: Week 0 (baseline), Week 12 ]
    End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).

  12. Change From Baseline to Study Period Average in Overall PAQLQ Score [ Time Frame: Week 0 (baseline), week 4, week 8, week 12 ]

    Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).

    The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1-7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated.


  13. Number of Patients With an Asthma Exacerbation During Study [ Time Frame: Week 0 (baseline) up to Week 12 ]
    Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2
  • Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal
  • Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.

Exclusion Criteria:

  • Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
  • Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1

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): NCT02091986


  Show 71 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: David S Pearlman, MD Colorado Allergy Asthma Centers, PC, US
Study Director: Carin Jorup, MD AstraZeneca Mölndal, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02091986     History of Changes
Other Study ID Numbers: D589GC00003
First Posted: March 19, 2014    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: February 2017

Keywords provided by AstraZeneca:
asthma, children, budesonide pMDI

Additional relevant MeSH terms:
Layout table for MeSH terms
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists