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Pulmonary Gas Exchange Response to Indacaterol in COPD

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ClinicalTrials.gov Identifier: NCT02547558
Recruitment Status : Unknown
Verified September 2015 by Isabel Blanco, Hospital Clinic of Barcelona.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Isabel Blanco, Hospital Clinic of Barcelona

Brief Summary:

To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011 groups.

Measurements on a single day before and after 60 and 120 minutes of indacaterol will include arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated. Cardiac output will be directly measured by bio-impedance.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Procedure: Arterial blood gases Procedure: Cardiac Output Procedure: Vital signs Procedure: Exhaled breath Procedure: Spirometry Drug: Indacaterol Phase 4

Detailed Description:

The investigators hypothesize that in stable chronic obstructive pulmonary disease (COPD) patients the interaction between intrapulmonary and extrapulmonary determinants contributing to gas exchange abnormalities after indacaterol will ultimately preserve arterial oxygenation (primary end-point outcome).

The study will include 20 outpatients with diagnosis of stable COPD in GOLD 2011 groups B and D (10 each), without frequent exacerbations (≥2 in the previous year). Patients with a COPD exacerbation within 3 months of study, use of long-term oxygen therapy and associated conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases) will be excluded.

Each patient will be studied on a single day. All subjects will remain on their regular treatment for the study. Subjects will be required to withhold SABAs for at least 12 h and LABAs and theophylline for at least 24 h before study. During measurements, patients will breath room air and will be seated in an armchair. Measurements will be performed before and 60 and 120 min after a single dose administration of indacaterol Breezhaler@ 300 mcg (1 inhalation).

After ensuring steady-state conditions, as assessed by stability (± 5%) of both ventilatory and hemodynamic variables, and by the close agreement (within ± 5%) between duplicate of mixed expired and arterial oxygen and carbon dioxide, a set of duplicate measurements for each variable will be obtained at each time point.

Blood samples will be collected through a catheter inserted under local anesthesia into the radial artery. Samples of blood (5 ml) will be removed for measurement of arterial O2 tension (PaO2), CO2 tension (PaCO2) and pH; alveolar-arterial PO2 difference (A-a)DO2, oxygen saturation (SaO2), and VO2, VCO2, Ve, respiratory rate (f), systemic arterial pressure (Psa), and heart rate (HR) will be measured or calculated, as previously described.

Cardiac output will be directly measured by bio-impedance. Spirometry values will be recorded from the history records of each patient. All measurements will be performed in the Centre de Diagnòstic Respiratori (CDR), Servei de Pneumologia, Institut del Tòrax, Hospital Clínic, Barcelona.

The primary outcome will be the PaO2 change after indacaterol at each analysis time. Based on a previous study in stable severe COPD patients using nebulized salbutamol during convalescence of exacerbation, Polverino et al. calculated that for a significant PaO2 fall of the order of 8 mmHg, a sample of 6 subjects is needed; this number was increased to 20 patients to ensure better data.

Secondary outcomes were changes in PaCO2, pH, the calculated D(A-a)DO2 and the response of cardiac output.

Results will be expressed as mean (±SEM) or median (95% CI). The effects of indacaterol on each of the end-point variables will be assessed by one-way repeated measures analysis of variance (ANOVA). Paired t tests and Pearson's correlation tests will be used as appropriate. All significances will be set at p<0.05, without correction for multiple tests.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulmonary Gas Exchange Response to Indacaterol in Stable Symptomatic Chronic Obstructive Pulmonary Disease Patients
Study Start Date : October 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Indacaterol

Arm Intervention/treatment
Experimental: Indacaterol

Drug:

-Indacaterol, inhaled, single dose, 300 mcg

Diagnostic Interventions:

  • Arterial blood gases
  • Cardiac output
  • Vital signs
  • Exhaled breath
  • Spirometry
Procedure: Arterial blood gases
Measured through radial arterial catheter
Other Names:
  • PaO2
  • PaCO2
  • pH
  • AaPO2

Procedure: Cardiac Output
Measured through bioimpedance: FloTrac pressure transducer (FloTrac sensor; Edwards Lifesciences) using the third-generation (3.01) FloTrac software for continuous CO display.
Other Name: CO

Procedure: Vital signs
As measured in clinical practice
Other Names:
  • Respiratory rate
  • Heart rate (HR)
  • Systemic arterial pressure

Procedure: Exhaled breath
Were recorded using a pneumotachograph (CPX/D; Med Graphics, St. Paul, MN, U.S.A.).
Other Names:
  • Oxygen
  • Carbon dioxide

Procedure: Spirometry
In a daily calibrated spirometer.
Other Names:
  • FEV1
  • VFC

Drug: Indacaterol
Indacaterol Breezhaler@ 300 mcg (1 inhalation)
Other Name: Ultra long acting beta 2 agonist




Primary Outcome Measures :
  1. Change in PaO2 after indacaterol. [ Time Frame: 60 and 120 minutes ]

Secondary Outcome Measures :
  1. Change in PaCO2 after indacaterol. [ Time Frame: 60 and 120 minutes ]
  2. Change in D(A-a)DO2 after indacaterol. [ Time Frame: 60 and 120 minutes ]
  3. Change in pH after indacaterol. [ Time Frame: 60 and 120 minutes ]
  4. Change in cardiac output after indacaterol. [ Time Frame: 60 and 120 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with COPD diagnosis according to GOLD 2011 criteria (VEF1/CVF less than 70%), groups B and D.

Exclusion Criteria:

  • Conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases).
  • Patients with frequent exacerbations (2 or more exacerbations in the past year).
  • History of acute COPD exacerbation in the previous 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547558


Contacts
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Contact: Isabel Blanco, MD, PhD +34 649539835 IBLANCO2@clinic.ub.es

Locations
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Spain
Hospital Clínic Not yet recruiting
Barcelona, Spain, 08036
Contact: Isabel Blanco, MD, PhD    +34 649539835    iblanco2@clinic.ub.es   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Isabel Blanco, MD, PhD Hospital Clínic

Publications:

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Responsible Party: Isabel Blanco, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02547558     History of Changes
Other Study ID Numbers: IndaEPOC
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015
Keywords provided by Isabel Blanco, Hospital Clinic of Barcelona:
Indacaterol
Pulmonary gas exchange
Long-acting bronchodilators
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases