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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305461
• Other study ID #: BY9010/AR-101
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2006
• Last updated: December 2, 2016
• Start date: February 2006
• Est. completion date: February 2008

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide
Effect of Ciclesonide on Quality of Life

Locations

Country	Name	City	State
Argentina	Altana Pharma/Nycomed	Buenos Aires
Argentina	Altana Pharma/Nycomed	Buenos Aires
Argentina	Altana Pharma/Nycomed	Buenos Aires
Argentina	Altana Pharma/Nycomed	Cap. Fed.
Argentina	Altana Pharma/Nycomed	Cap. Fed.
Argentina	Altana Pharma/Nycomed	Cap. Fed.
Argentina	Altana Pharma/Nycomed	Cap. Fed.
Argentina	Altana Pharma/Nycomed	Cordoba
Argentina	Altana Pharma/Nycomed	Cordoba
Argentina	Altana Pharma/Nycomed	Mendoza
Argentina	Altana Pharma/Nycomed	Santa Fe
Argentina	Altana Pharma/Nycomed	Tucuman

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in Quality of Life from AQLQ(S) (T end versus T0)		8 weeks	No
Primary	time to first exacerbation		8 weeks	No
Primary	differences in FEV1 and FVC from spirometry (T end vs T0).		8 weeks	No
Secondary	percentage of days on which patients perceived asthma control		8 weeks	No
Secondary	percentage of asthma symptoms free days		8 weeks	No
Secondary	percentage of rescue medication-free days		8 weeks	No
Secondary	percentage of nocturnal awakening-free days		8 weeks	No
Secondary	asthma symptom score (daytime score, nighttime score, total score)		8 weeks	No
Secondary	use of rescue medication		8 weeks	No
Secondary	PEF from spirometry		8 weeks	No
Secondary	morning and evening PEF from diary		8 weeks	No
Secondary	diurnal PEF fluctuation.		8 weeks	No

External Links

•   BY9010-AR-101-RDS-2009-06-19.pdf