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

Asthma Clinical Trial

— CHASE 1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136382
• Other study ID #: D589GC00001
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2010
• Last updated: July 30, 2014
• Start date: July 2010
• Est. completion date: April 2013

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyHungary: National Institute of PharmacyLatvia: State Agency of MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: Ministry of Public HealthSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide
pMDI, inhalation, bid, 6 weeks
• placebo
pMDI, inhalation, bid, 6 weeks

Locations

Country	Name	City	State
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sofia
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyor
Hungary	Research Site	Kiskunhalas
Hungary	Research Site	Marcali
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Sopron
Hungary	Research Site	Szeged
Hungary	Research Site	Szigetvar
Hungary	Research Site	Torokbalint
Hungary	Research Site	Zalaegerszeg
Latvia	Research Site	Ogre
Latvia	Research Site	Rezekne
Latvia	Research Site	Riga
Poland	Research Site	Bialystok
Poland	Research Site	Czestochowa
Poland	Research Site	Karpacz
Poland	Research Site	Lodz
Poland	Research Site	Pabianice
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Lucenec
South Africa	Research Site	Claremont	W Cape
South Africa	Research Site	Durban	Kwa Zulu Natal
South Africa	Research Site	Krugersdorp	Gauteng
South Africa	Research Site	Panorama	W Cape
South Africa	Research Site	Pietermariztburg	Kwa Zulu Natal
United States	Research Site	Albany	Georgia
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Bellevue	Nebraska
United States	Research Site	Bethesda	Maryland
United States	Research Site	Boseman	Montana
United States	Research Site	Canton	Ohio
United States	Research Site	Centennial	Colorado
United States	Research Site	Charleston	South Carolina
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	Missouri
United States	Research Site	Coral Gables	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	El Paso	Texas
United States	Research Site	Fort Worth	Texas
United States	Research Site	Fresno	California
United States	Research Site	Gainesville	Georgia
United States	Research Site	Georgetown	Texas
United States	Research Site	Granada Hills	California
United States	Research Site	Greenfield	Wisconsin
United States	Research Site	Gresham	Oregon
United States	Research Site	High Point	North Carolina
United States	Research Site	Huntington Beach	California
United States	Research Site	Lake Oswego	Oregon
United States	Research Site	Medford	Oregon
United States	Research Site	Mission Viejo	California
United States	Research Site	Normal	Illinois
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	Ocean	New Jersey
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orange	California
United States	Research Site	Orange City	Florida
United States	Research Site	Overland Park	Kansas
United States	Research Site	Palmdal	California
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plymouth	Minnesota
United States	Research Site	Portland	Oregon
United States	Research Site	Richmond	Virginia
United States	Research Site	Rockville Centre	New York
United States	Research Site	Rolling Hills Estate	California
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Sarasota	Florida
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Skillman	New Jersey
United States	Research Site	St Louis	Missouri
United States	Research Site	Stockton	California
United States	Research Site	Sylvania	Ohio
United States	Research Site	Teaneck	New Jersey
United States	Research Site	Toledo	Ohio
United States	Research Site	Upland	Pennsylvania
United States	Research Site	Waco	Texas
United States	Research Site	West Allis	Wisconsin
United States	Research Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Bulgaria,  Hungary,  Latvia,  Poland,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average	The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.	Baseline to 6 weeks	No
Secondary	Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average	FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.	Baseline to 6 weeks	No
Secondary	Change in Evening PEF From Baseline to the Treatment Period Average	The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.	Baseline to 6 weeks	No
Secondary	Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average	FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.	Baseline to 6 weeks	No
Secondary	Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average	FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.	Baseline to 6 weeks	No
Secondary	Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average	Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were 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.	Baseline to 6 weeks	No
Secondary	Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average	Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were 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.	Baseline to 6 weeks	No
Secondary	Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average	Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, "Did your asthma cause you to wake-up last night?" If yes, patients were asked, "Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?" Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period.	Baseline to 6 weeks	No
Secondary	Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average	The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?"	Baseline to 6 weeks	No
Secondary	Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average	The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?"	Baseline to 6 weeks	No
Secondary	Number of Withdrawals Due to Pre-defined Asthma Events	Patients were considered to have experienced a "pre-defined asthma event" if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.	Baseline to 6 weeks	No