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

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ClinicalTrials.gov Identifier: NCT00305461
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : December 5, 2016
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : February 2006
Primary Completion Date : March 2007
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. differences in Quality of Life from AQLQ(S) (T end versus T0) [ Time Frame: 8 weeks ]
  2. time to first exacerbation [ Time Frame: 8 weeks ]
  3. differences in FEV1 and FVC from spirometry (T end vs T0). [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. percentage of days on which patients perceived asthma control [ Time Frame: 8 weeks ]
  2. percentage of asthma symptoms free days [ Time Frame: 8 weeks ]
  3. percentage of rescue medication-free days [ Time Frame: 8 weeks ]
  4. percentage of nocturnal awakening-free days [ Time Frame: 8 weeks ]
  5. asthma symptom score (daytime score, nighttime score, total score) [ Time Frame: 8 weeks ]
  6. use of rescue medication [ Time Frame: 8 weeks ]
  7. PEF from spirometry [ Time Frame: 8 weeks ]
  8. morning and evening PEF from diary [ Time Frame: 8 weeks ]
  9. diurnal PEF fluctuation. [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305461

Altana Pharma/Nycomed
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
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca
More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00305461     History of Changes
Other Study ID Numbers: BY9010/AR-101
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
Quality of Life

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