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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Bergeron, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01560689
First received: March 20, 2012
Last updated: September 6, 2012
Last verified: September 2012
History of Changes

March 20, 2012
September 6, 2012
June 2008
July 2012   (final data collection date for primary outcome measure)
  • pulmonary function tests [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Dyspnea based on NYHA classification [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01560689 on ClinicalTrials.gov Archive Site
pulmonary function test [ Time Frame: 7 month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation
Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Bronchiolitis Obliterans
  • Allogeneic Stem Cell Transplantation
  • Drug: Budesonide/formoterol
    800 µg/j twice a day, every day
    Other Name: Symbicort
  • Drug: Placebo
    Twice a day, every day
  • Active Comparator: BUDESONIDE/FORMOTEROL
    Intervention: Drug: Budesonide/formoterol
  • Placebo Comparator: control
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01560689
2
Yes
Anne Bergeron, Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: bergeron-lafaurie Anne, MD, PhD Pneumology Department, Hopital Saint Louis
Assistance Publique - Hôpitaux de Paris
September 2012

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