Closing Volume Interpretation and Bronchodilators Effect

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Milan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Pierachille Santus, University of Milan
ClinicalTrials.gov Identifier:
NCT01437748
First received: September 12, 2011
Last updated: September 20, 2011
Last verified: September 2011
  Purpose
  • The gold standard measures to evaluate small airways (SAW) "in vivo" is not well understood
  • Two tests are today used to measure SAW but real results concordance is not clear
  • These problems have a small evidence
  • Data about real effect of bronchodilators on SAW (eg Tiotropium and Indacaterol) has never been studied
  • Only an acute bronchodilators effect, after one hour of drugs inhalation, will be evaluated
  • The time frame of study evaluations per patient will be of three hours: one hour for basal test; one hour rest after drug administration; one hour for post bronchodilators test
  • All enrolled subjects will be outpatients and will be evaluated after 24 hours of inhalatory drugs washout

Condition Intervention Phase
Healthy
COPD
Drug: Indacaterol maleate
Drug: Tiotropium bromide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Small Airways Evaluation and Peripherical Effect of Two Bronchodilators in Healthy Subjects and Stable COPD Patients

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Closing Volume (CV) [ Time Frame: Participants will be followed for the duration of medical office stay an expected average of 3 hours. The outcome measure will be assessed for the end of october 2011 and will be presented within december 2011. ] [ Designated as safety issue: No ]
    The evaluation of CV will be performed by EB. The oesophageal balloon is introduced by nose and located in distal oesophageal tract. By pressure transducer the correct position will be confirmed. After the investigators will perform the evaluation of lung volume, trans pleural pressure and flow. These parameters will be registered at tidal volume, during forced expiration and finally during hyperventilation.

  • Closing Capacity (CC) [ Time Frame: Participants will be followed for the duration of medical office stay an expected average of 3 hours. The outcome measure will be assessed for the end of october 2011 and will be presented within december 2011 ] [ Designated as safety issue: No ]
    The evaluation of CC will be measuired by Single Breath Test (SBT) and performed by pneumotachograph matched with a gas analyzer. Patient breath normally for some seconds, exhales to residual volume (RV) and after that deeply inhales oxygen (100%) to total lung capacity (TLC), then the patient exhales slowly to RV. This test will be repeated a minimum of three times.


Secondary Outcome Measures:
  • Effect of Tiotropium or Indacaterol on CV and CC registration [ Time Frame: Participants will be followed for the duration of medical office stay an expected average of 3 hours. The outcome measure will be assessed for the end of october 2011 and will be presented within december 2011 ] [ Designated as safety issue: No ]
    Possible effect on small airways by two distinct ultra long acting bronchodilators

  • Comparison concordance of CV and CC [ Time Frame: Participants will be followed for the duration of medical office stay an expected average of 3 hours. The outcome measure will be assessed for the end of october 2011 and will be presented within december 2011 ] [ Designated as safety issue: No ]
    This data will be important to identify the best, easiest and most reliable test for clinical SAW evaluation


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol
Indacaterol 300 mcg will be administered by a third independent investigator following a randomization list
Drug: Indacaterol maleate
Dry powder, 300 mcg, only one inhalation with 24 hours duration
Active Comparator: Tiotropium
Tiotropium 18 mcg, will be administered with the same device of indacaterol by a third independent investigator
Drug: Tiotropium bromide
Dry powder, 18 mcg, only one inhalation with 24 hours duration

Detailed Description:

Evaluation of small airways both in healthy and Chronic Obstructive Pulmonary Disease (COPD)subjects still today remains a big problem with implications in diagnostic and clinical management. The first lung alteration in smokers is the bronchiolitis and possibility to understand real damage on this anatomical district should be very interesting. The first point of the study will be the SAW evaluation. The two principal technics to do this are: Single Breath Test (SBT) and oesophageal balloon (EB). With SBT is possible to obtain the four expiration phases and so the shift from phase 3 to phase 4 identifying the point called closing capacity (CC). With EB is possible to obtain the lung static pressure-volume curve and after this to identify the point of closing volume (CV). The real concordance of CC and CV has never been studied both in healthy and COPD subjects.

The SBT is performed by pneumotachograph matched with a gas analyzer. Patient breath normally for some seconds, exhales to residual volume (RV) and after that deeply inhales oxygen (100%) to total lung capacity (TLC), then the patient exhales slowly to RV. This test will be repeated a minimum of three times.

The evaluation of CV will be performed by EB. The oesophageal balloon is introduced by nose and located in distal oesophageal tract. By pressure transducer the correct position will be confirmed. After the investigators will perform the evaluation of lung volume, trans pleural pressure and flow. These parameters will be registered at tidal volume, during forced expiration and finally during hyperventilation.

So, after the identification of presence,absence and eventually concordance of CC and CV should be interesting to evaluate the possible effect on SAW of bronchodilators usually used in clinical practice. More in detail, the investigators will administered in random order and after basal evaluation of CV and CC dry powder of indacaterol 300 micrograms (mcg) or Tiotropium 18 mcg. After one hour of drug administration the investigators will repeat the maneuver for CC and CV evaluations. In this way, will be evaluated only the acute effect of the bronchodilators on lung hyperinflation. Each subjects will perform plethysmographic test too. Bronchodilators will be administered only to the COPD patients.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signature of informed consent
  • Healthy subjects with age from 20 to 80 yars old and never smokers
  • COPD diagnosis
  • COPD with age from 50 to 85 years old
  • History of COPD at least of noe year
  • Respiratory stable conditions at least of one month
  • Any basal FEV1 expressed in % of predicted value
  • FEV1/Forced Vital Capacity (FVC) less than 70%
  • COPD with history of former or active smokers with minimum of 20 pack year

Exclusion Criteria:

  • Pregnancy
  • FEV1/FVC more than 70%
  • Known deficit of alpha 1 antitrypsin
  • Subjects submitted to a Lung Volume Reduction Surgery (LVRS)
  • Subjects with known positivity to Human Immunodeficiency Virus (HIV)
  • Known intolerance to a nasogastric balloon
  • Misuse of alcool or drugs
  • Absence of compliance in performing respiratory test
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437748

Contacts
Contact: Pierachille Santus, MD, PhD +390250725122 pierachille.santus@unimi.it
Contact: Dejan Radovanovic, MD +3902507259 dejan.radovanovic@studenti.unimi.it

Locations
Italy
Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS Recruiting
Milano, Italy, 20138
Contact: Pierachille Santus, MD, PhD    +390250725122    pierachille.santus@unimi.it   
Contact: Dejan Radovanovic, MD    +3902507259    dejan.radovanovic@studenti.unimi.it   
Sub-Investigator: Dejan Radovanovic, MD         
Sponsors and Collaborators
University of Milan
Fondazione Salvatore Maugeri
Investigators
Study Director: Pierachille Santus, MD, PhD Università degli Studi di Milano-Pneumologia Riabilitativa-Fondazione Salvatore Maugeri-MILANO
  More Information

No publications provided

Responsible Party: Pierachille Santus, Head of Respiratory Rehabilitation Unit, University of Milan
ClinicalTrials.gov Identifier: NCT01437748     History of Changes
Other Study ID Numbers: 629CEC
Study First Received: September 12, 2011
Last Updated: September 20, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
Small Airways
Closing volume
Closing Capacity
Tiotropium
Indacaterol
COPD

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Bromides
Bronchodilator Agents
Tiotropium
Maleic acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 23, 2014