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Trial record 85 of 857 for:    ALBUTEROL

Bronchodilator Responsiveness in Obliterative Bronchiolitis (BD-OB)

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ClinicalTrials.gov Identifier: NCT01112241
Recruitment Status : Completed
First Posted : April 28, 2010
Results First Posted : February 23, 2011
Last Update Posted : March 2, 2011
Sponsor:
Information provided by:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Obliterative Bronchiolitis
Intervention Drug: albuterol plus tiotropium
Enrollment 17
Recruitment Details Between April 2010 and May 2010, seventeen consecutive bronchiolitis obliterans (BOS) patients following hematopoietic stem cell transplantation (HSCT) were studied.
Pre-assignment Details In all patients, airflow obstruction was found at spirometry between 14 and 72 months (median, 41 months) after HSCT. The diagnosis of BOS was confirmed by fulfilment of currently updated criteria [Filipovich AH et al. Biol Blood Marrow Transplant 2005; 11:945-956][Chien JW et al. Biol Blood Marrow Transplant 2010; 16:S106-S114].
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description 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®).
Period Title: Overall Study
Started 17
Completed 17
Not Completed 0
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description 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®).
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
48  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
5
  29.4%
Male
12
  70.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 17 participants
17
1.Primary Outcome
Title Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: per cent positive change
Responsives to bronchodilators (n=4) 14  (1)
Unresponsives to bronchodilators (n=13) 7  (5)
2.Primary Outcome
Title Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: absolute positive change (liters)
Responsives to bronchodilators (n=4) 0.26  (0.06)
Unresponsives to bronchodilators (n=13) 0.12  (0.09)
3.Primary Outcome
Title Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: per cent positive change
Responsives to bronchodilators (n=5) 24  (13)
Unresponsives to bronchodilators (n=12) 2  (4)
4.Primary Outcome
Title Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: absolute positive change (liters)
Responsives to bronchodilators (n=5) 0.65  (0.37)
Unresponsives to bronchodilators (n=12) 0.07  (0.15)
5.Primary Outcome
Title Per Cent Change of Instantaneous Maximal Forced Expiratory Flow (V'Max) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following HSCT for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: per cent positive change
Responsives to bronchodilators (n=4) 66  (17)
Unresponsives to bronchodilators (n=13) 14  (14)
6.Primary Outcome
Title Per Cent Change of Partial Forced Expiratory Flow (V'Part) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: per cent positive change
Responsives to bronchodilators (n=9) 59  (26)
Unresponsives to bronchodilators (n=8) 17  (7)
7.Primary Outcome
Title Per Cent Change of Residual Volume (RV) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: per cent negative change
Responsives to bronchodilators (n=8) 19  (5)
Unresponsives to bronchodilators (n=9) 0  (5)
8.Primary Outcome
Title Absolute Change of Residual Volume (RV) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: absolute negative change (liters)
Responsives to bronchodilators (n=8) 0.65  (0.37)
Unresponsives to bronchodilators (n=9) 0.00  (0.10)
9.Primary Outcome
Title Per Cent Change of Functional Residual Capacity (FRC) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: per cent negative change
Responsives to bronchodilators (n=4) 16  (6)
Unresponsives to bronchodilators (n=13) 2  (5)
10.Primary Outcome
Title Absolute Change of Functional Residual Capacity (FRC) After Bronchodilators
Hide Description 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].
Time Frame Baseline and 90 min after bronchodilators
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description:
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®).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: absolute negative change (liters)
Responsives to bronchodilators (n=4) 0.78  (0.34)
Unresponsives to bronchodilators (n=13) 0.07  (0.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol Plus Tiotropium
Hide Arm/Group Description 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®).
All-Cause Mortality
Albuterol Plus Tiotropium
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol Plus Tiotropium
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albuterol Plus Tiotropium
Affected / at Risk (%)
Total   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Giovanni Barisione, MD
Organization: Azienda Ospedaliera Universitaria San Martino, Genova, Italy
Phone: +39 010 5553367
EMail: giovanni.barisione@hsanmartino.it
Layout table for additonal information
Responsible Party: Giovanni Barisione, Unit of Preventive and Occupational Medicine - Laboratory of Respiratory Pathophysiology
ClinicalTrials.gov Identifier: NCT01112241     History of Changes
Other Study ID Numbers: BOS-01
First Submitted: April 27, 2010
First Posted: April 28, 2010
Results First Submitted: November 30, 2010
Results First Posted: February 23, 2011
Last Update Posted: March 2, 2011