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Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation (alloforb)

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.
 
ClinicalTrials.gov Identifier: NCT01560689
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : September 7, 2012
Sponsor:
Information provided by (Responsible Party):
Anne Bergeron, Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE March 20, 2012
First Posted Date  ICMJE March 22, 2012
Last Update Posted Date September 7, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2012)
  • pulmonary function tests [ Time Frame: 1 month ]
  • Dyspnea based on NYHA classification [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01560689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2012)
pulmonary function test [ Time Frame: 7 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation
Official Title  ICMJE Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation
Brief Summary The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.
Detailed Description Bronchiolitis obliterans (BO) is a life-threatening pulmonary late-onset complication following allogenic stem cell transplantation (SCT), commonly attributed to graft versus host disease (GVHD), and carries a poor prognosis. Although immunosuppressive treatments (IS) represents the main therapeutic approach in this disorder, these medications are rarely efficient and alternative approaches are strongly needed. Because, the combination of inhaled steroids and long-acting bronchodilator are known to decrease respiratory symptoms, prevent exacerbations and improve lung function in chronic obstructive pulmonary diseases with bronchiolar component, they may have beneficial effects in BO. Thus, the investigators conducted a pilot open-labeled trial to evaluate the therapeutic effects of inhaled Budesonide/Formoterol combination (400/12 µg twice a day) without modifying systemic IS received by the patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bronchiolitis Obliterans
  • Allogeneic Stem Cell Transplantation
Intervention  ICMJE
  • Drug: Budesonide/formoterol
    800 µg/j twice a day, every day
    Other Name: Symbicort
  • Drug: Placebo
    Twice a day, every day
Study Arms  ICMJE
  • Active Comparator: BUDESONIDE/FORMOTEROL
    Intervention: Drug: Budesonide/formoterol
  • Placebo Comparator: control
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2012)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult allogeneic stem cell transplant recipients with clinical respiratory signs assumed to be secondary to BO, without extra-thoracic extensive graft versus host disease

Exclusion Criteria:

  • Extensive extra thoracic GVH necessitating increasing immunosuppressive treatments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01560689
Other Study ID Numbers  ICMJE 2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne Bergeron, Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: bergeron-lafaurie Anne, MD, PhD Pneumology Department, Hopital Saint Louis
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP