Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis

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Brief Title

Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis

Official Title

Bronchiectasis in COPD Patients : Role of Prophylaxis With Inhaled Steroids and Antibiotic on the Natural History of the Disease

Brief Summary

      Bronchiectasis is a chronic pulmonary disease characterized by an irreversible dilatation of
      the bronchi. The current view of the pathogenesis of bronchiectasis considers initial
      colonization of the lower respiratory tract by different microorganisms as the first step
      leading to an inflammatory response characterized by neutrophil migration within the airways
      and secondary secretion of a variety of tissue-damaging oxidants and enzymes such as
      neutrophil elastase and myeloperoxidase. Persistence of microorganisms in the airways because
      of impairment in mucus clearance may lead to a vicious circle of events characterized by
      chronic bacterial colonization, persistent inflammatory reaction, and progressive tissue
      damage. The exact prevalence of bronchiectasis in COPD patients is not known. It would be
      important to assess the prevalence, the kind of bronchiectasis and the bacterial
      colonisation. These are all important features that can be related to the natural history of
      COPD and to the therapeutic management of patient with COPD and bronchiectasis. Recent data
      indicate that macrolide long-term treatment and inhaled steroids therapy are both associated
      with a reduced rate of exacerbation, bronchial colonization and inflammation The present
      study will address, on a relatively large number of patients, the prevalence of
      bronchiectasis in COPD subjects using a multislice CT scan technique applied in all the units
      and centrally analysed by Unit 2 and 4. This analysis will determine the presence and the
      morphology of bronchiectasis. Bacterial colonization and inflammatory parameters will be
      evaluated on blood and exhalate bronchial condensate. Concerning bacterial colonization
      molecular biology techniques (Qualitative PCR and quantitative real time PCR) will be
      applied. ELISPOT technique for the evaluation of specific immune response will be
      used.Electron and optical microscopy techniques will be applied on bronchial biopsy samples
      obtained in a subgroup of patients enrolled. During the second study year, a randomized trial
      on patients with bronchiectasis will be performed. Patients will be randomized to receive a
      macrolide or inhaled steroids or standard of care for 6 months with a follow-up of 6 months.
      All the inflammatory, microbiologic and functional parameters described above will be
      recorded. A clinical and functional evaluation will be applied looking to number of
      exacerbations, quality of life, respiratory function parameters.
    

Detailed Description

      AIMS OF THE STUDY

      As previously described the research program aims are the following:

        -  definition of bronchiectasis prevalence in patients affected by chronic obstructive
           pulmonary disease.

        -  After bronchiectasis patients identification, we will evaluate the pathophysiologic
           implications, and microbiologic and inflammatory features of this subgroup in comparison
           to non-bronchiectasis patients.

        -  Finally, the research will address the effects of long-term treatments with inhaled
           steroids and antibiotic on the natural history of the disease and their pathophysiologic
           implications. To these purposes, the study will be divided into two sections. In the Ist
           section 400 patients with COPD will be recruited. In these patients we intend to assess
           the prevalence of bronchiectasis using a CT spiral scanning. We will also detect
           bacterial colonisation by real time PCR and ELIspot technique, and airway inflammation
           by a non-invasive method (exhaled breath condensate) comparing patients with and without
           bronchiectasis.

      COPD patients with bronchiectasis:

      In this population we will study the effect of different "prophylaxis" i.e., macrolide and
      inhaled steroids.

      Details of the Interventions Proposed STABLE COPD The patient will attend the clinic in the
      morning for enrolment, and provide written informed consent. During the visit medical history
      will be recorded and subjects will undergo a physical examination and lung function testing
      at baseline and post salbutamol 200 mcg. CT scan, exhaled breath condensate and the
      venopuncture will also be performed. Sputum samples will be obtained for bacterial
      colonization assessment.

      Respiratory Assessment:

      Lung function testing will be performed using a Fleish No. 3 heated pneumotachograph; the
      plethysmographic measurements, thoracic gas volume (TGV), residual volume (RV), total lung
      capacity (TLC), will be assessed using a body plethysmograph (Werner Gut, Basle, Switzerland)
      with electronic BTPS compensation at a constant volume (850L). DLCO determination will be
      performed.

      CT scan All the multislice CT (MSCT) scan performed will be centrally analysed by UO 4 . The
      following protocol will be followed

        1. MSCT in inspiration at TLC with slice of 1 mm every 10 + 3 expiratory slices at RV using
           three predetermined levels (aortic arch, tracheal carina, right basal common vein)

        2. Technical parameters: 120 kV, 220 mA, filter bone, FOV including both lung, lung
           parenchyma window (-600/1600 HU)

        3. All CT will be saved on CD rom Two radiologists will analyse the same CT, every
           discrepancy will be solved by consensus

      The diagnosis and evaluation of bronchiectasis will be performed according to Webb et al.
      (1):

      The evaluation will be performed lobe by lobe including lingula (total lobes= 6)

        1. bronchiectasis extension on lobar base: 0, 1 (< 25% of the lobe), 2 (25-50%), 3 (>50%) -
           MAX TOT 18

        2. severity and kind of bronchiectasis and semi-quantitative, comparing the diameter to
           that of the adjacent artery: 0, 1 (bronchial diameter equal to 100-200% artery
           diameter), 2 (200-300%), 3 (> 300%) - MAX TOT 18

        3. Thickness of bronchial walls: 0, 1 (Thickness < 50% artery diameter), 2 (50-100%), 3 (
           complete obliteration of lumen or Hydro-air levels) - MAX TOT 18

        4. Evaluation of emphysema (visual score on three levels (inspiration) (aortic arch,
           carina, vein)

        5. Evaluation of air trapping in expiration (idem)

        6. Bullae

        7. Ground glass areas (extension by visual score)

        8. bronchiolitis: prevalent site, lobar involvement, severity ( 0,1,2,3)

        9. Pulmonary artery diameter (pathological if > 2,9 cm)

       10. Other features

      Exhaled breath condensate:

      Exhaled breath condensate will be collected by using a condenser, which allows the
      non-invasive collection of nongaseous components of the expiratory air (EcoScreen, Jaeger,
      Germany). Subjects breathe tidally through a mouthpiece connected to the inlet for 8 min
      while wearing a nose-clip. The mouthpiece is also used as a saliva trap. Approximately 1 ml
      of breath condensate is collected and stored at -70° C. IL-6, IL-8, TNF-a and
      cysteinyl-leukotrienes (cys-LTs) will be measured by specific enzyme immunoassays (EIA)
      (Cayman Chemical, Ann Arbor, MI). Moreover proteomic analysis will be performed on the subset
      of patients enrolled by UO1 as previously reported (2); briefly, one-dimensional and
      two-dimensional electrophoresis will be performed and for qualitative evaluation and mass
      spectrometry analysis, the gels will be stained with silver nitrate, with or without
      glutaraldehyde in the sensitization step and formaldehyde in the impregnation solution. Spot
      volumes will be calculated using Image J 1.29x (W. Rasband, National Institutes of Health,
      Bethesda, Maryland) for one-dimensional gels, and with PDQUEST (Biorad, Hercules, California)
      for two-dimensional gels.

      Serum Samples:

      Serum aliquots will be arranged in duplicate and stored at - 20°C until the time of analysis.
      IL-6, IL-8, TNF-a and cysteinyl-leukotrienes (cys-LTs) will be measured by specific enzyme
      immunoassays (EIA) (Cayman Chemical, Ann Arbor, MI).

      C-reactive protein and procalcitonin will be also measured.(3) UO 1 The ex-vivo Enzyme-Linked
      ImmunoSPOT (ELISPOT) assay is the most sensitive tool to detect and quantify the
      antigen-specific T-cell response, and can detect and enumerate T-cells producing one or more
      cytokines in response to specific antigens. This technique has been already used to detect
      low numbers of antigen-specific T-cells in infectious disorders, with particular emphasis to
      intracellular pathogens such as Mycobacterium tuberculosis . The ELISPOT technique is
      becoming a standard reference for the monitoring of many infectious diseases, including HIV
      infection, and is becoming more and more used in advanced clinical immunological
      applications, such as the detection of an antigen-specific T cell immune responses to
      oncogene peptides.

      In the context of the proposed project, the ELISPOT technology will be used to detect the
      presence of a systemic (blood) and local (bronchoalveolar lavage) antigen-specific response
      using peptide pools of non tuberculous mycobacteria and other intracellular bacteria (such as
      Mycoplasma pneumoniae), bacteria (such as Pseudomonas spp) and fungi (such as Aspergillus
      species). The ELISPOT tests will be performed on samples of whole blood (after Ficoll
      separation of peripheral mononuclear cells) and bronchoalveolar cells measuring the number of
      T cells producing interferon-gamma after an overnight incubation with the specific antigenic
      peptide pools. (4-8)

      Sputum collection:

      A sample of spontaneous sputum will be obtained from all patients. Alternatively induced
      sputum according to Pizzichini, et al (9) will be collected. In summary, induced sputum is
      obtained after inhalation of hypertonic saline water at 3% for 20 minutes using an ultrasonic
      nebulizer (Ultraneb 2000; DeVilbiss Healthcare Inc, Somerset, PS, USA).Only samples of sputum
      degree IV or V of Murray-Washington classification (10) will be processed. A sputum sample
      will be frozen at -70°C for bacterial DNA detection using a PCR (qualitative analysis) and
      real time PCR (quantitative analysis) techniques.

      The following Bacteria wil be detected using standard protocol in use in UO1: H. influenzae,
      M. catarrhalis, S. pneumoniae, P.

      aeruginosa, Mycoplasma pneumoniae, Chlamydia pneumoniae. An aliquot will be cultivated using
      standard microbiologic techniques Patients 400 patients will be recruited at the UO 1,2,3 e
      5. All the CT scan will be collected and examined at UO 4. UO2 will serve as second observer
      in a double-blind fashion; any discrepancy will be solved by consensus.

      One subgroup of patients with stable COPD (n=15) and an subgroup of patients with COPD and
      bronchiectasis (n=15) will undergo bronchoscopy with biopsy collection. Subjects will be
      premedicated with atropine and anesthetized topically with lidocaine.

      Bronchoscopy will be performed with a flexible fiberoptic bronchoscope. Bronchial biopsies
      will be taken through the bronchoscope with standard forceps from the carina of the basal
      segment bronchus of the right lower lobe. From this area two specimens will be obtained in
      each patients. Bronchial biopsies obtained will be prepared for electronic and light
      microscopy analysis (UO3 and UO 1).

      Sample size: we can expect at least a 30% prevalence of bronchiectasis that means 120
      patients to be included in the second step of the study (11)

      COPD PATIENTS WITH BRONCHIECTASIS:

      In this population we will study the effect of different "prophylaxis" i.e. macrolide and
      inhaled steroids. The population will be followed for 12 months.

      The following procedure will be performed every 3 months and at each exacerbations:

      Clinical assessment, Exhaled breath condensate, Serum Sampling, Sputum collection.

      On biological samples all the previously described techniques plus renal and hepatic function
      tests (safety) will be performed.

      Sputum culture will be performed to assess bacterial flora and resistance patterns.

      Design of the study:

      120 patients will be randomized in 3 groups (40 pts) to receive :

        1. Standard of care

        2. azithromycin 500 mg OD 3 days a week (Monday, Wednesday, Friday) for 6 months and then
           inhaled steroids (fluticasone 500 ug bid) for 6 months

        3. inhaled steroids (fluticasone 500 ug bid) for 6 months and then azithromycin 500 mg OD 3
           days a week (Monday, Wednesday, Friday) for 6 months

      End-points:

      PRIMARY

        -  effects of treatments on bronchial inflammation parameters SECONDARY

        -  effects of treatments on exacerbations frequency

        -  effects of treatments on pulmonary function

      Sample size:

      We can expect a 40% difference between treated and non-treated patients for at least one
      among TNFa, IL6, IL8, and cysteinyl-leukotrienes. In this case we need 35 treated patients
      (for each arm) and 35 non-treated patients for an alpha error of 0.05 and a beta of 0.1.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

effects of treatments on bronchial inflammation parameters

Secondary Outcome

 effects of treatments on exacerbations frequency

Condition

Bronchiectasis

Intervention

azithromycin and fluticasone

Study Arms / Comparison Groups

 1
Description:  standard of care

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

210

Start Date

September 2006

Completion Date

February 2009

Primary Completion Date

July 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Smokers or former smokers of at least 10 pack-years

          -  COPD demonstrated by forced spirometry with FEV1 > 0,7 L, FEV1 post-BD <60% and
             FEV1/FVC < 70%

          -  Bronchodilator test performed at inclusion or no more than 6 months before inclusion
             should have been negative (increase in FEV1 < 200 ml and 12%, 10 minutes after
             administration of 2 puffs of salbutamol

          -  Stable phase defined by clinical criteria of the attending investigator, but at least
             6 weeks from the last exacerbation

          -  Informed consent

        Exclusion Criteria:

          -  Patients receiving oral corticosteroids at any dose or another immunosuppressor

          -  Formal contraindication for sputum collection or impossibility to obtain a sample of
             sputum valid for analysis.

          -  Allergy to steroids or macrolides
      

Gender

All

Ages

45 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Francesco Blasi, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00524095

Organization ID

PRIN2005

Secondary IDs

MIUR 2005067041 PRIN 2005


Study Sponsor

University of Milan


Study Sponsor

Francesco Blasi, MD, Study Director, University of Milan Italy


Verification Date

March 2009