Closing Volume Interpretation and Bronchodilators Effect

NCT01437748 | Completed Phase 4 DMC

• 1 other identifier: 629CEC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Healthy; COPD

Keywords

Small Airways; Closing volume; Closing Capacity; Tiotropium; Indacaterol; COPD

Outcome Measures

Primary Outcomes (2)

• Closing Volume (CV)

  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.

  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.

• Closing Capacity (CC)

  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.

  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

Secondary Outcomes (2)

• Effect of Tiotropium or Indacaterol on CV and CC registration

  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

• Comparison concordance of CV and CC

  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

Study Arms (2)

Indacaterol maleate

EXPERIMENTAL

Indacaterol 300 mcg via Breezehaler Inhaler will be administered by a third independent investigator not involved in the performing of any of the tests decribed, following a randomization list

Drug: Indacaterol maleate

Tiotropium bromide

ACTIVE COMPARATOR

Tiotropium 18 mcg, via HandiHaler inhaler will be administered by a third independent investigator not involved in the performing of any of the tests decribed, following a randomization list

Drug: Tiotropium bromide

Interventions

Indacaterol maleate DRUG

Dry powder, 300 mcg, only one inhalation with 24 hours duration

Also known as: Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta

Indacaterol maleate

Tiotropium bromide DRUG

Dry powder, 18 mcg, only one inhalation with 24 hours duration

Also known as: Spiriva

Tiotropium bromide

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead
• Fondazione Salvatore Maugeri: collaborator

Study Sites (1)

Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS

Milan, Milano, 20138, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Pierachille Santus, MD, PhD

  Università degli Studi di Milano-Pneumologia Riabilitativa-Fondazione Salvatore Maugeri-MILANO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Respiratory Rehabilitation Unit

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 21, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

IT (1)