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Ciclesonide for the Treatment of Airway Hyperresponsiveness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharma AG )
ClinicalTrials.gov Identifier:
NCT00826969
First received: January 21, 2009
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.


Condition Intervention Phase
Asthma
 Drug: Ciclesonide
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-blind, Randomized, Parallel Group Study.

Resource links provided by NLM:

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

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Level of exhaled nitric oxide after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean change of ACQ after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean change of AQLQ after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Exacerbation rates during the 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: September 2008
Study Completion Date: October 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ciclesonide 320µg
 Drug: Ciclesonide
320µg Ciclesonide versus Placebo
Placebo Comparator: 2
Placebo
 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness.
  2. Asthma symptoms partly controlled according to GINA (October 2006) 1 week prior to randomization
  3. FEV1 ≥ 70% predicted
  4. 18 - 70 years old

Exclusion Criteria:

  1. Smoker and ex-smoker with >10 pack years
  2. COPD
  3. Upper respiratory tract infection within the past 4 weeks.
  4. ICS or oral steroids during the previous month before inclusion
  5. b-blockers within the past 4 weeks
  6. Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers)
  7. Pregnancy
  8. Known malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826969

Locations
Switzerland
Nycomed
Basel, Switzerland, 4031
Sponsors and Collaborators
Takeda Pharma AG
Investigators
Study Chair: Nycomed Clinical Trial Management Headquarter
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Takeda Pharma AG )
ClinicalTrials.gov Identifier: NCT00826969     History of Changes
Other Study ID Numbers: BY9010/CH-101, U1111-1137-3949
Study First Received: January 21, 2009
Last Updated: February 4, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Takeda Global Research & Development Center, Inc.:
Asthma
Ciclesonide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Ciclesonide
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013