Obliterative BronchiolitisPhase 4BD-OBNCT01112241

Bronchodilator Responsiveness in Obliterative Bronchiolitis

A Phase 4 study testing albuterol plus tiotropium in people with Obliterative Bronchiolitis, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study has been designed to provide a substantial evidence of acute bronchodilator responsiveness to two sequentially inhaled drugs, a beta2-agonist (i.e., albuterol) and an anticholinergic (i.e., tiotropium bromide), in a group of patients who developed obliterative bronchiolitis after hematopoietic stem cell… Read more about this study

Who is it for?: Any age
Conditions the study is for: Obliterative Bronchiolitis
What is being tested?: albuterol plus tiotropium
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteItaly
Study dates: Apr 2010to May 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Obliterative bronchiolitis (OB) following allogeneic HSCT
FEV1 to slow inspiratory vital capacity (VC) ratio (FEV1/VC)<5th percentile
FEV1 <75% predicted or absolute FEV1 fall >10% of pre-HSCT value
evidence of OB by computed tomography scanning
negative microbiological yields in bronchoalveolar lavage fluid
chronic graft-versus-host disease score >0
negative history for bronchial asthma, chronic obstructive pulmonary disease or other significant respiratory disease.

Who cannot join

inability to perform lung function maneuvers
pre-existent chronic lung disease other than OB

Trial locations and contacts

1 site in 1 country.

Italy1 site

Unit of Preventive and Occupational Medicine - Laboratory of Respiratory Pathophysiology, University Hospital San Martino
Genoa, 16132

Other trials in Italy

About this study

Official title: Acute Bronchodilator Responsiveness in Obliterative Bronchiolitis (OB) Following Hematopoietic Stem Cell Transplantation

Read the detailed description

Obliterative bronchiolitis is a life-threatening non-infectious pulmonary complication of allogeneic hematopoietic stem cell transplantation (HSCT). It is characterized by the development of an obstructive abnormality which has been considered to be insensitive to bronchodilator treatments. However, this knowledge stems from measurements of forced expiratory volume in 1 s (FEV1) which is relatively insensitive to changes in small airway caliber. Moreover, it is known from studies in chronic obstructive pulmonary disease that symptoms improve after bronchodilator treatment even when FEV1 is minimally increased and correlate with the reduction of lung hyperinflation, which is the major consequence of severe expiratory airflow limitation. Therefore, measurements of airway caliber by parameters not affected by volume history and absolute lung volumes are preferable for assessing the effect of bronchodilator interventions.

In the current study, the bronchodilators responsiveness will be assessed by using not only spirometry but also measurements of absolute lung volumes and the forced expiratory flow of a partial maneuver (V'part) started from submaximal lung inflation, thus free of volume history effects.

Conditions: Obliterative Bronchiolitis
Being tested: albuterol plus tiotropium
Keywords: Obliterative bronchiolitis, Bronchodilator responsiveness, Partial forced expiratory flow, Lung volumes
Medical subject headings: Bronchiolitis Obliterans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

albuterol plus tiotropiumDrug
Also called Ventolin® and Spiriva®
Four separate doses of 100 μg of albuterol and 18 μg of tiotropium bromide. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber and tiotropium by a dry-powder device.

Study groups in NCT01112241
Study group	Role	What they receive
albuterol-tiotropium	Experimental	At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®). Receives: Drug: albuterol plus tiotropium

What is being measured

The primary outcome is the main question the study is designed to answer.

Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators
Following albuterol plus tiotropium inhalation, FEV1 increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1, expressed in liters (L), after bronchodilators - FEV1 (L) before bronchodilators/FEV1 (L) before bronchodilators x 100].
Measured: Baseline and 90 min after bronchodilators
Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators
Following albuterol plus tiotropium inhalation, FEV1 increments ≥0.20 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1 (L) after bronchodilators - FEV1 (L) before bronchodilators].
Measured: Baseline and 90 min after bronchodilators
Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators
Following albuterol plus tiotropium inhalation, FVC increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC, expressed in liters (L), after bronchodilators - FVC (L) before bronchodilators/FVC (L) before bronchodilators x 100].
Measured: Baseline and 90 min after bronchodilators
Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators
Following albuterol plus tiotropium inhalation, FVC increments ≥0.20 liters (L) compared with baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC (L) after bronchodilators - FVC (L) before bronchodilators].
Measured: Baseline and 90 min after bronchodilators
Per Cent Change of Instantaneous Maximal Forced Expiratory Flow (V'Max) After Bronchodilators
Following albuterol plus tiotropium inhalation, V'max increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'max, expressed in liters.second-1 (L.s-1), after bronchodilators - V'max (L.s-1) before bronchodilators/V'max (L.s-1) before bronchodilators x 100].
Measured: Baseline and 90 min after bronchodilators
Per Cent Change of Partial Forced Expiratory Flow (V'Part) After Bronchodilators
Following albuterol plus tiotropium inhalation, V'part increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'part, expressed in liters.second-1 (L.s-1), after bronchodilators - V'part (L.s-1) before bronchodilators/V'part (L.s-1) before bronchodilators x 100].
Measured: Baseline and 90 min after bronchodilators
Per Cent Change of Residual Volume (RV) After Bronchodilators
Following albuterol plus tiotropium inhalation, RV decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV, expressed in liters (L), before bronchodilators - RV (L) after bronchodilators/RV (L) after bronchodilators x 100].
Measured: Baseline and 90 min after bronchodilators
Absolute Change of Residual Volume (RV) After Bronchodilators
Following albuterol plus tiotropium inhalation, RV decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV (L), before bronchodilators - RV (L) after bronchodilators].
Measured: Baseline and 90 min after bronchodilators
Per Cent Change of Functional Residual Capacity (FRC) After Bronchodilators
Following albuterol plus tiotropium inhalation, FRC decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC, expressed in liters (L), before bronchodilators - FRC (L) after bronchodilators/FRC (L) after bronchodilators x 100].
Measured: Baseline and 90 min after bronchodilators
Absolute Change of Functional Residual Capacity (FRC) After Bronchodilators
Following albuterol plus tiotropium inhalation, FRC decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC (L), before bronchodilators - FRC (L) after bronchodilators].
Measured: Baseline and 90 min after bronchodilators

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010May 2010

First posted28 Apr 2010 (estimated)
Study startApr 2010
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Obliterative BronchiolitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01112241
Sponsor's protocol ID: BOS-01
Acronym: BD-OB
Status last verified: Apr 2010
First submitted: 27 Apr 2010
Last updated: 2 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pellegrino R, Rodarte JR, Brusasco V. Assessing the reversibility of airway obstruction. Chest. 1998 Dec;114(6):1607-12. doi: 10.1378/chest.114.6.1607.
PubMed 9872196
Barisione G, Bacigalupo A, Crimi E, Van Lint MT, Lamparelli T, Brusasco V. Changes in lung volumes and airway responsiveness following haematopoietic stem cell transplantation. Eur Respir J. 2008 Dec;32(6):1576-82. doi: 10.1183/09031936.0139807. Epub 2008 Aug 6.
PubMed 18684842
Barisione G, Bacigalupo A, Crimi E, Brusasco V. Acute bronchodilator responsiveness in bronchiolitis obliterans syndrome following hematopoietic stem cell transplantation. Chest. 2011 Mar;139(3):633-639. doi: 10.1378/chest.10-1442. Epub 2010 Aug 19.
PubMed 20724742

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
Back Pain Lower Back Chronic
Not yet recruitingPhase 4
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
Chronic Graft Versus Host Disease
RecruitingPhase 3
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
Graft-versus-host Disease (GVHD)
Active, not recruitingObservational study
Improving Outcomes Assessment in Chronic GVHD
Chronic Graft Versus Host Disease

All Obliterative Bronchiolitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Bronchodilator Responsiveness in Obliterative Bronchiolitis (OB) Following Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT01112241
Acronym / sponsor ID: BD-OB / BOS-01
Conditions: Obliterative Bronchiolitis
Keywords: Obliterative bronchiolitis, Bronchodilator responsiveness, Partial forced expiratory flow, Lung volumes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
Study start: Apr 2010
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 28 Apr 2010 (estimated)
Results: Posted 23 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
albuterol-tiotropium	Experimental	Drug: albuterol plus tiotropiumAt visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Obliterative bronchiolitis (OB) following allogeneic HSCT
FEV1 to slow inspiratory vital capacity (VC) ratio (FEV1/VC)<5th percentile
FEV1 <75% predicted or absolute FEV1 fall >10% of pre-HSCT value
evidence of OB by computed tomography scanning
negative microbiological yields in bronchoalveolar lavage fluid

Key exclusion criteria (2 listed)

inability to perform lung function maneuvers
pre-existent chronic lung disease other than OB

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
albuterol plus tiotropiumAlso: Ventolin® and Spiriva®Four separate doses of 100 μg of albuterol and 18 μg of tiotropium bromide. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber and tiotropium by a dry-powder device.	Drug	albuterol-tiotropium

Primary outcome

Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, FEV1 increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1, expressed in liters (L), after bronchodilators - FEV1 (L) before bronchodilators/FEV1 (L) before bronchodilators x 100].
Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, FEV1 increments ≥0.20 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1 (L) after bronchodilators - FEV1 (L) before bronchodilators].
Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, FVC increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC, expressed in liters (L), after bronchodilators - FVC (L) before bronchodilators/FVC (L) before bronchodilators x 100].
Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, FVC increments ≥0.20 liters (L) compared with baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC (L) after bronchodilators - FVC (L) before bronchodilators].
Per Cent Change of Instantaneous Maximal Forced Expiratory Flow (V'Max) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, V'max increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'max, expressed in liters.second-1 (L.s-1), after bronchodilators - V'max (L.s-1) before bronchodilators/V'max (L.s-1) before bronchodilators x 100].
Per Cent Change of Partial Forced Expiratory Flow (V'Part) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, V'part increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'part, expressed in liters.second-1 (L.s-1), after bronchodilators - V'part (L.s-1) before bronchodilators/V'part (L.s-1) before bronchodilators x 100].
Per Cent Change of Residual Volume (RV) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, RV decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV, expressed in liters (L), before bronchodilators - RV (L) after bronchodilators/RV (L) after bronchodilators x 100].
Absolute Change of Residual Volume (RV) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, RV decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV (L), before bronchodilators - RV (L) after bronchodilators].
Per Cent Change of Functional Residual Capacity (FRC) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, FRC decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC, expressed in liters (L), before bronchodilators - FRC (L) after bronchodilators/FRC (L) after bronchodilators x 100].
Absolute Change of Functional Residual Capacity (FRC) After Bronchodilators
Time frame: Baseline and 90 min after bronchodilators
Following albuterol plus tiotropium inhalation, FRC decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC (L), before bronchodilators - FRC (L) after bronchodilators].

Results and safety

Results posted to the registry on 23 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Albuterol Plus Tiotropium	17	17

Primary outcome: Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators

Time frame: Baseline and 90 min after bronchodilators. Mean (Standard Deviation). Unit: per cent positive change

Measure	Albuterol Plus Tiotropium n = 17
Responsives to bronchodilators (n=4)	14 (1)
Unresponsives to bronchodilators (n=13)	7 (5)

Population analysed: Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).

Primary outcome: Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators

Time frame: Baseline and 90 min after bronchodilators. Mean (Standard Deviation). Unit: absolute positive change (liters)

Measure	Albuterol Plus Tiotropium n = 17
Responsives to bronchodilators (n=4)	0.26 (0.06)
Unresponsives to bronchodilators (n=13)	0.12 (0.09)

Primary outcome: Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators

Time frame: Baseline and 90 min after bronchodilators. Mean (Standard Deviation). Unit: per cent positive change

Measure	Albuterol Plus Tiotropium n = 17
Responsives to bronchodilators (n=5)	24 (13)
Unresponsives to bronchodilators (n=12)	2 (4)

Primary outcome: Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators

Time frame: Baseline and 90 min after bronchodilators. Mean (Standard Deviation). Unit: absolute positive change (liters)

Measure	Albuterol Plus Tiotropium n = 17
Responsives to bronchodilators (n=5)	0.65 (0.37)
Unresponsives to bronchodilators (n=12)	0.07 (0.15)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Albuterol Plus Tiotropium	0 of 17 (0%)	0 of 17 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9872196Pellegrino R, Rodarte JR, Brusasco V. Assessing the reversibility of airway obstruction. Chest. 1998 Dec;114(6):1607-12. doi: 10.1378/chest.114.6.1607.
Background: PubMed 18684842Barisione G, Bacigalupo A, Crimi E, Van Lint MT, Lamparelli T, Brusasco V. Changes in lung volumes and airway responsiveness following haematopoietic stem cell transplantation. Eur Respir J. 2008 Dec;32(6):1576-82. doi: 10.1183/09031936.0139807. Epub 2008 Aug 6.
Results publication: PubMed 20724742Barisione G, Bacigalupo A, Crimi E, Brusasco V. Acute bronchodilator responsiveness in bronchiolitis obliterans syndrome following hematopoietic stem cell transplantation. Chest. 2011 Mar;139(3):633-639. doi: 10.1378/chest.10-1442. Epub 2010 Aug 19.

Related trials for Obliterative Bronchiolitis

Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
Back Pain Lower Back Chronic
Not yet recruitingPhase 4
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
Chronic Graft Versus Host Disease
RecruitingPhase 3
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
Graft-versus-host Disease (GVHD)
Active, not recruitingObservational study
Improving Outcomes Assessment in Chronic GVHD
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giovanni Barisione, MD principal investigator

Unit of Preventive and Occupational Medicine, University Hospital San Martino, Genoa, Italy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators (time frame: Baseline and 90 min after bronchodilators). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01112241, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.