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Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Ciclesonide
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Quality of Life, Ciclesonide

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Written informed consent Good health with the exception of asthma Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0 Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0 Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol Patients compliant to recommended pre-treatment Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids Chronic obstructive pulmonary disease (COPD) Hospitalization within previous four weeks from baseline Hospitalization due to asthma within the last twelve months Asthma exacerbation within two months previous to baseline History of almost fatal asthma at any moment Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women Exacerbation of asthma within 2 months prior to entry into the baseline period Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months

Sites / Locations

  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Ciclesonide 160µg

Ciclesonide 320µg

Outcomes

Primary Outcome Measures

differences in Quality of Life from AQLQ(S) (T end versus T0)
time to first exacerbation
differences in FEV1 and FVC from spirometry (T end vs T0).

Secondary Outcome Measures

percentage of days on which patients perceived asthma control
percentage of asthma symptoms free days
percentage of rescue medication-free days
percentage of nocturnal awakening-free days
asthma symptom score (daytime score, nighttime score, total score)
use of rescue medication
PEF from spirometry
morning and evening PEF from diary
diurnal PEF fluctuation.

Full Information

First Posted
March 21, 2006
Last Updated
December 2, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00305461
Brief Title
Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)
Official Title
A Pilot Study on the Impact of Two Different Doses of Ciclesonide (160 mcg/Day and 320 mcg/Day) Administered in the Evening on Quality of Life in Patients With Moderate Persistent Asthma.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. The study duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Quality of Life, Ciclesonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Ciclesonide 160µg
Arm Title
2
Arm Type
Active Comparator
Arm Description
Ciclesonide 320µg
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Intervention Description
Effect of Ciclesonide on Quality of Life
Primary Outcome Measure Information:
Title
differences in Quality of Life from AQLQ(S) (T end versus T0)
Time Frame
8 weeks
Title
time to first exacerbation
Time Frame
8 weeks
Title
differences in FEV1 and FVC from spirometry (T end vs T0).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
percentage of days on which patients perceived asthma control
Time Frame
8 weeks
Title
percentage of asthma symptoms free days
Time Frame
8 weeks
Title
percentage of rescue medication-free days
Time Frame
8 weeks
Title
percentage of nocturnal awakening-free days
Time Frame
8 weeks
Title
asthma symptom score (daytime score, nighttime score, total score)
Time Frame
8 weeks
Title
use of rescue medication
Time Frame
8 weeks
Title
PEF from spirometry
Time Frame
8 weeks
Title
morning and evening PEF from diary
Time Frame
8 weeks
Title
diurnal PEF fluctuation.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Written informed consent Good health with the exception of asthma Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0 Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0 Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol Patients compliant to recommended pre-treatment Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids Chronic obstructive pulmonary disease (COPD) Hospitalization within previous four weeks from baseline Hospitalization due to asthma within the last twelve months Asthma exacerbation within two months previous to baseline History of almost fatal asthma at any moment Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women Exacerbation of asthma within 2 months prior to entry into the baseline period Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Buenos Aires
ZIP/Postal Code
B1902CSK
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Buenos Aires
ZIP/Postal Code
B7540GHQ
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Buenos Aires
ZIP/Postal Code
B8000AAT
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Cap. Fed.
ZIP/Postal Code
C1117ABE
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Cap. Fed.
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Cap. Fed.
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Cap. Fed.
ZIP/Postal Code
C1427ARN
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Cordoba
ZIP/Postal Code
X5000BFB
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Mendoza
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Altana Pharma/Nycomed
City
Tucuman
ZIP/Postal Code
T4146DAL
Country
Argentina

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4506&filename=BY9010-AR-101-RDS-2009-06-19.pdf
Description
BY9010-AR-101-RDS-2009-06-19.pdf

Learn more about this trial

Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)

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