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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00305461
First received: March 21, 2006
Last updated: May 4, 2012
Last verified: June 2009
  Purpose

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).


Condition Intervention Phase
Asthma
Drug: Ciclesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Takeda:

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 ]

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 ]

Enrollment: 101
Study Start Date: February 2006
Study Completion Date: February 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305461

Locations
Argentina
Altana Pharma/Nycomed
Buenos Aires, Argentina, B7540GHQ
Altana Pharma/Nycomed
Buenos Aires, Argentina, B8000AAT
Altana Pharma/Nycomed
Buenos Aires, Argentina, B1902CSK
Altana Pharma/Nycomed
Cap. Fed., Argentina, C1121ABE
Altana Pharma/Nycomed
Cap. Fed., Argentina, C1221ADC
Altana Pharma/Nycomed
Cap. Fed., Argentina, C1117ABE
Altana Pharma/Nycomed
Cap. Fed., Argentina, C1427ARN
Altana Pharma/Nycomed
Cordoba, Argentina, X5016KEH
Altana Pharma/Nycomed
Cordoba, Argentina, X5000BFB
Altana Pharma/Nycomed
Mendoza, Argentina, M5500CCG
Altana Pharma/Nycomed
Santa Fe, Argentina, S2000DSV
Altana Pharma/Nycomed
Tucuman, Argentina, T4146DAL
Sponsors and Collaborators
Takeda
Investigators
Study Director: Osvaldo Colatruglio, MD ALTANA Pharma S.A Argentina
  More Information

No publications provided

Responsible Party: Nycomed GmbH, Nycomed
ClinicalTrials.gov Identifier: NCT00305461     History of Changes
Other Study ID Numbers: BY9010/AR-101
Study First Received: March 21, 2006
Last Updated: May 4, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Takeda:
Asthma
Quality of Life
Ciclesonide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Ciclesonide
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014