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Completed

NCT Number: NCT00306163

Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)

The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed

RB Groningen, 9700, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • History of bronchial asthma
  • FEV1 > 1.20 L
  • Positive Skin Prick Test
  • Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit

Main Exclusion Criteria:

  • Clinically relevant abnormal laboratory values
  • Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
  • Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases
  • One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
  • Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
  • Positive response to saline challenge at baseline visits
  • Positive bronchial hyperresponsiveness

Treatment and study plan

Ciclesonide

Drug

inhaled Ciclesonide 160 µg, once daily in the morning

Fluticasone

Drug

inhaled Fluticasone 100 µg, twice daily

Primary outcomes

  1. PC20 AMP (Post-treatment Compared to Baseline)

    Time frame: Baseline and 5 weeks

    Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron

Secondary outcomes

  1. Δ (FVC/SVC) at PC20 (AMP)

    Time frame: Baseline and 5 weeks

    Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP.

  2. Safety and Tolerability

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 23, 2006
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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