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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 21, 2006

Last Updated Date

July 16, 2008

Start Date ^†

February 2006

Current Primary Outcome Measures ^†

differences in Quality of Life from AQLQ(S) (T end versus T0) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
time to first exacerbation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
differences in FEV1 and FVC from spirometry (T end vs T0). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original 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).

Change History

Complete list of historical versions of study NCT00305461 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

percentage of days on which patients perceived asthma control [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
percentage of asthma symptoms free days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
percentage of rescue medication-free days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
percentage of nocturnal awakening-free days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
asthma symptom score (daytime score, nighttime score, total score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
use of rescue medication [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
PEF from spirometry [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
morning and evening PEF from diary [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
diurnal PEF fluctuation. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original 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.

Descriptive Information

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.

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).

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment

Condition ^†

Asthma

Intervention ^†

Drug: Ciclesonide

Study Arms / Comparison Groups

Active Comparator: Ciclesonide 160µg
Active Comparator: Ciclesonide 320µg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

101

Completion Date

February 2008

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

21 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Argentina

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00305461

Responsible Party

Nycomed GmbH, Nycomed

Secondary IDs ^††

Study Sponsor ^†

ALTANA Pharma

Collaborators ^††

Investigators ^†

Study Director:

Osvaldo Colatruglio, MD

ALTANA Pharma S.A Argentina

Information Provided By

ALTANA Pharma

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.