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

December 2, 2016 updated by: AstraZeneca

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1902CSK
        • Altana Pharma/Nycomed
      • Buenos Aires, Argentina, B7540GHQ
        • Altana Pharma/Nycomed
      • Buenos Aires, Argentina, B8000AAT
        • Altana Pharma/Nycomed
      • Cap. Fed., Argentina, C1117ABE
        • Altana Pharma/Nycomed
      • Cap. Fed., Argentina, C1121ABE
        • Altana Pharma/Nycomed
      • Cap. Fed., Argentina, C1221ADC
        • Altana Pharma/Nycomed
      • Cap. Fed., Argentina, C1427ARN
        • Altana Pharma/Nycomed
      • Cordoba, Argentina, X5000BFB
        • Altana Pharma/Nycomed
      • Cordoba, Argentina, X5016KEH
        • Altana Pharma/Nycomed
      • Mendoza, Argentina, M5500CCG
        • Altana Pharma/Nycomed
      • Santa Fe, Argentina, S2000DSV
        • Altana Pharma/Nycomed
      • Tucuman, Argentina, T4146DAL
        • Altana Pharma/Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Ciclesonide 160µg
Drug: Ciclesonide
Effect of Ciclesonide on Quality of Life
Active Comparator: 2
Ciclesonide 320µg
Drug: Ciclesonide
Effect of Ciclesonide on Quality of Life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
differences in Quality of Life from AQLQ(S) (T end versus T0)
Time Frame: 8 weeks
8 weeks
time to first exacerbation
Time Frame: 8 weeks
8 weeks
differences in FEV1 and FVC from spirometry (T end vs T0).
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
percentage of days on which patients perceived asthma control
Time Frame: 8 weeks
8 weeks
percentage of asthma symptoms free days
Time Frame: 8 weeks
8 weeks
percentage of rescue medication-free days
Time Frame: 8 weeks
8 weeks
percentage of nocturnal awakening-free days
Time Frame: 8 weeks
8 weeks
asthma symptom score (daytime score, nighttime score, total score)
Time Frame: 8 weeks
8 weeks
use of rescue medication
Time Frame: 8 weeks
8 weeks
PEF from spirometry
Time Frame: 8 weeks
8 weeks
morning and evening PEF from diary
Time Frame: 8 weeks
8 weeks
diurnal PEF fluctuation.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY9010/AR-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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