A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo (CHASE 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01136382
First received: June 1, 2010
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to <12 years


Condition Intervention Phase
Asthma
Drug: budesonide
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Double-blind, Randomized, Parallel-group, Placebo-controlled, Multicenter Study, Comparing Budesonide pMDI 160 ug Bid With Placebo: a 6-week Efficacy and Safety Study in Children Aged 6 to <12 Years With Asthma

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Morning PEF [ Time Frame: Every morning during 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 [ Time Frame: at clinic visits, before and after a maximum of two weeks run-in and then after 1, 2, 3, 4, 5 and 6 weeks of treatment ] [ Designated as safety issue: No ]
  • FVC [ Time Frame: at clinic visits, before and after a maximum of two weeks run-in and then after 1, 2, 3, 4, 5 and 6 weeks of treatment ] [ Designated as safety issue: No ]
  • FEF25-75 [ Time Frame: at clinic visits, before and after a maximum of two weeks run-in and then after 1, 2, 3, 4, 5 and 6 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 304
Study Start Date: July 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid)
Drug: budesonide
pMDI, inhalation, bid, 6 weeks
Placebo Comparator: 2
Placebo pMDI 2 inhalations bid
Drug: placebo
pMDI, inhalation, bid, 6 weeks

Detailed Description:

Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in children aged 6 to <12 years with asthma

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 2 that has required daily inhaled corticosteroid in the low dose range OR LTRA as monotherapy for at least 30 days prior to Visit 2.
  • Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last dose of inhaled short acting beta agonist of greater than or equal to 70% and less than or equal to 95% of predicted normal
  • Demonstrated reversibility of FEV1 of ≥12% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist OR has a documented reversibility of ≥ 12 % within 12 months prior to Visit 2.

Exclusion Criteria:

  • Has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma-related condition during the 6 months prior to Visit 2
  • Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 2
  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: NCT01136382

  Show 87 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Göran Eckerwall, MD AZ R&D Mölndal
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01136382     History of Changes
Other Study ID Numbers: D589GC00001
Study First Received: June 1, 2010
Last Updated: April 26, 2013
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ministry of Public Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council

Keywords provided by AstraZeneca:
asthma, children, budesonide pMDI

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 10, 2014