Ciclesonide for the Treatment of Airway Hyperresponsiveness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826969
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : September 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Active Comparator: 1
Ciclesonide 320µg
Drug: Ciclesonide
320µg Ciclesonide versus Placebo
Placebo Comparator: 2
Drug: Placebo

Primary Outcome Measures :
  1. Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given) [ Time Frame: 4 weeks ]
  2. Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment [ Time Frame: 4 weeks ]
  3. Level of exhaled nitric oxide after 4 weeks of treatment [ Time Frame: 4 weeks ]
  4. mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper) [ Time Frame: 4 weeks ]
  5. Mean change of ACQ after 4 weeks of treatment [ Time Frame: 4 weeks ]
  6. Mean change of AQLQ after 4 weeks of treatment [ Time Frame: 4 weeks ]
  7. Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment [ Time Frame: 4 weeks ]
  8. Exacerbation rates during the 4 weeks of treatment [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00826969

Basel, Switzerland, 4031
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00826969     History of Changes
Other Study ID Numbers: BY9010/CH-101
U1111-1137-3949 ( Registry Identifier: WHO )
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: October 2016

Keywords provided by AstraZeneca:

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