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National Guideline Clearinghouse (NGC). Guideline summary: Chronic obstructive pulmonary disease (COPD) In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): cited 2002 Apr 27 (revised 2007 Feb 7). Available: http://www.guideline.gov.

Bibliographic Source(s)

• Finnish Medical Society Duodecim. Chronic obstructive pulmonary disease (COPD). In: EBM Guidelines. Evidence-Based Medicine [Internet]. Helsinki Finland: Wiley Interscience. John Wiley & Sons; 2007 Feb 7 [Various].

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Finnish Medical Society Duodecim. Chronic obstructive pulmonary disease (COPD). In: EBM Guidelines. Evidence-Based Medicine [CD-ROM]. Helsinki Finland: Duodecim Medical Publications Ltd.; 2005 Mar 2 [various].

Guideline Category

Diagnosis
Management
Treatment

Intended Users

Health Care Providers
Physicians

Guideline Objective(s)

Evidence-Based Medicine Guidelines collect summarize and update the core clinical knowledge essential in general practice. The guidelines also describe the scientific evidence underlying the given recommendations.

Target Population

• Adults with chronic obstructive pulmonary disease (COPD)
• Adults requiring evaluation for possible chronic obstructive pulmonary disease

Interventions and Practices Considered

Diagnosis

1. Physical examination and assessment of signs and symptoms
2. Spirometry in combination with active promotion of smoking cessation
3. Assessment of forced expiratory volume in one second/forced vital capacity (FEV₁/FVC)
4. Test with a bronchodilating drug and subsequent assessment of response (as measured by spirometry and bronchodilator dose or peak expiratory flow [PEF] follow-up)
5. Evaluation of the effectiveness of anti-inflammatory treatment with a trial of steroids (oral prednisolone or inhaled steroid)
6. Assessment of diffusion capacity
7. Blood gas analysis
8. Chest radiograph

Treatment

1. Cessation of smoking
2. Drug therapy
   • Bronchodilating medication (Inhaled short acting or long acting anticholinergic drug; inhaled beta-sympathomimetic; oral long-acting theophylline)
   • Anti-inflammatory medication
3. Nonpharmacologic measures to promote mucous excretion
4. Treatment of acute exacerbation (oxygen by nasal catheter or by venturi mask; noninvasive positive pressure ventilation; an inhaled sympathomimetic possibly in combination with an inhaled ipratropium bromide methyl prednisolone or oral corticosteroids
5. Treatment of acute infection with antimicrobials
6. Exercise
7. Vaccinations (influenza pneumococcal)
8. Oxygen therapy at home

Major Outcomes Considered

• Symptom relief
• Exercise capacity
• Lung function (as measured by spirometry)
• Morbidity and mortality
• Quality of life
• Frequency and severity of exacerbations

Methods Used to Collect/Select Evidence

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Description of Methods used to Collect/Select the Evidence

The evidence reviewed was collected from the Cochrane database of systematic reviews and the Database of Abstracts of Reviews of Effectiveness (DARE). In addition the Cochrane Library and medical journals were searched specifically for original publications.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Levels of Evidence

1. Quality of Evidence: High

   Further research is very unlikely to change confidence in the estimate of effect

   • Several high-quality studies with consistent results
   • In special cases: one large high-quality multi-centre trial

2. Quality of Evidence: Moderate

   Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.

   • One high-quality study
   • Several studies with some limitations

3. Quality of Evidence: Low

   Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.

   • One or more studies with severe limitations

4. Quality of Evidence: Very Low

   Any estimate of effect is very uncertain.

   • Expert opinion
   • No direct research evidence
   • One or more studies with very severe limitations

Methods Used to Analyze the Evidence

Review of Published Meta-Analyses
Systematic Review

Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

Peer Review

Description of Method of Guideline Validation

Not stated

Major Recommendations

The levels of evidence [A-D] supporting the recommendations are defined at the end of the "Major Recommendations" field.

Basic Rules

• Consider the diagnosis of chronic obstructive pulmonary disease (COPD) in any smoker who has cough and sputum production (de Marco et al. 2007).
• The diagnosis should be made early by spirometry. By this time at the latest the patient should give up smoking. (See the Finnish Medical Society Duodecim guideline "Smoking Cessation.").
• According to international criteria (Global Initiative for Chronic Obstructive Lung Disease [GOLD]) forced expiratory volume in one second/forced vital capacity (FEV₁/FVC) is below 0.7 in COPD.
• Most important differential diagnostic problem is asthma. Also many asthmatics smoke.

Definitions

• Chronic bronchitis: sputum at least for 3 months in 2 consecutive years.
• Pulmonary emphysema (is a pathologic anatomic diagnosis): terminal air spaces widen and alveolar walls rupture.
• Chronic obstructive pulmonary disease (COPD): the patient has chronic progressive airway obstruction with poor response to treatment. Other typical findings include chronic bronchitis and emphysema in varying grades depending on the patient.

Aetiology

• Most COPD patients (>95%) are smokers. Half of those who smoke have symptoms of chronic bronchitis. A slowly aggravating airway obstruction is detected in more than 25% of long-term smokers.
• Deficiency of alpha-1-antitrypsin is a rare cause of emphysema in young patients.

Symptoms

• Cough and sputum excretion are the most common symptoms.
• Patients with progressive disease suffer from slowly increasing dyspnoea during exercise.
• The symptoms are aggravated by respiratory infection.

Signs

• Most patients seek for a doctor late when the disease is already moderate to severe. In mild disease auscultation may be normal and no auscultatory signs for obstruction can be detected.
• The following symptoms indicate severe COPD; their absence does not exclude the existence of mild COPD:
  • Because of airway obstruction wheezing rattles may be heard at the end of forced expiration.
  • The patient with advanced emphysema may have a barrel-chested appearance on auscultation silent respiratory sounds are heard and on percussion the sound is hypersonor.
  • Cyanosis is associated with hypoxaemia.

Complications

• Acute
  • Repeated and prolonged lower respiratory infections
  • Acute respiratory failure
  • Pneumothorax (disruption of emphysematic bullae)
• Chronic
  • Chronic respiratory failure cardiopulmonary disease

Diagnosis

• Early diagnosis by spirometry combined with active promotion of smoking cessation is pursued.
• Test with a bronchodilating drug (See the Finnish Medical Society Duodecim guideline "Pulmonary Function Tests.").
  • The response to a bronchodilating drug is measured either by spirometry that is combined with a dose of a broncholytic drug (e.g. inhaled salbutamol 400 micrograms) or by peak expiratory flow (PEF)-measurements performed before and after the administration of the drug. In COPD there is no response (cf. asthma).
• The effectiveness of anti-inflammatory treatment is evaluated with a trial of steroids.
  • Oral prednisolone initially 30 to 40 mg/day (if necessary give protection against ulcers e.g. a proton pump inhibitor [PPI]) or inhaled steroid (e.g. budesonide 400 to 800 micrograms twice daily). In oral administration the duration is 2 weeks with an inhaled steroid 6 weeks.
  • An objective response (PEF increase >20% and/or FEV₁ increase >12% and at least 200 mL) is indicative of asthma.
• Diffusion capacity
  • Decreased in COPD
• Blood gas analysis
  • In late stages of COPD arterial blood oxygen partial pressure (pO₂) decreases and carbon dioxide partial pressure (pCO₂) may increase
• Chest x-ray is of limited value in COPD diagnosis
• According to the international criteria the threshold value for the diagnosis of mild COPD is FEV₁/FVC <70% after the bronchodilating test when FEV% is >80%.

Treatment

Cessation of Smoking

• The most essential factor regarding the prognosis.
• Does not normalize lung function but the progressive deterioration of FEV₁ slows down and proceeds at the same pace as in non-smokers.
• According to present knowledge there is no drug therapy available that could essentially delay the deterioration of lung function if the patient continues smoking. Drugs are only useful for relieving subjective symptoms and in the treatment of acute exacerbations.
• See the Finnish Medical Society Duodecim guideline "Smoking Cessation."

Basic Rules of Drug Therapy

• Mild disease
  • Asymptomatic patients
    • No drug therapy
  • Patients with occasional symptoms (generally FEV₁ >50% predicted)
    • Anticholinergics or short-acting beta-2-agonists according to clinical response
    • Trial of steroids if asthma is suspected
• Continuous symptoms (FEV₁ generally <50% predicted)
  • Anticholinergics or short-acting beta-2-agonists (combined) according to clinical response or
  • Long acting anticholinergics or beta-2-agonists or their combination
  • In selected cases inhaled glucocorticoid if frequent exacerbations
  • Trial of theophylline if symptoms persist (Ram et al. 2002) [A]
  • Surgery (bullectomy lung transplantation lung volume reduction) can be recommended only to a small subset of the patients after careful evaluation.

Bronchodilating Medication

• Inhaled short acting (ipratropium [McCrory & Brown 2002] [B] oxitropium bromide) or long acting (tiotropium [Barr et al. 2005] [A]) anticholinergic drug.
  • First line treatment
  • The dose must be high enough; administration 4 to 6 times daily with the short acting drug once a day with the long acting tiotropium.
• Inhaled beta-sympathomimetic (salbutamol terbutaline fenoterol) (Sestini et al. 2002) [B]
  • May be combined with an anticholinergic drug
  • Long-acting beta-sympathomimetics (formoterol salmeterol [Appleton et al. 2001] [B]) may improve quality of life and reduce symptoms.
• Oral long-acting theophylline (Ram et al. 2002) [A]
  • Adverse effects (central nervous system gastrointestinal symptoms) are common (follow-up of serum concentrations is necessary).
  • Arrhythmias and convulsions are signs of toxicity.
  • Keep in mind various interactions with other drugs (e.g. antibiotics).

Anti-inflammatory Medication

Inhaled steroids are only prescribed for patients with frequent exacerbations (van Grunsven et al. 1999; Alsaeedi Sin & McAlister 2002; Highland Strange & Heffner 2003) [B].

Treatment of Mucous Excretion

• If production of mucus is a problem the patient is recommended to perform regular self-initiated mucus drainage sessions at home by exhaling air through a straw into a water-filled bottle after which the expectorated mucus is coughed up (Jones & Rowe 1998) [D].
• Mucolytic agents should be used only temporarily (Poole & Black 2003) [B].

Treatment of Acute Exacerbation

• Oxygen by nasal catheter or by venturi mask. Caution should be exercised when dosing (if the result of an arterial blood gas analysis is not available the concentration of mask oxygen should not exceed 28% or nasal catheter flow should not exceed 2 L/min in patients above the age of 50 years).
• Non-invasive positive pressure ventilation using a mask improves recovery in severe acute exacerbation of COPD (Ram et al. 2004; Keenan et al. 2003) [A]
• An inhaled sympathomimetic (salbutamol 2.5 to 5 mg or terbutaline 5 to 10 mg) by a dosing device or a spray. Inhaled ipratropium bromide 0.5 mg is usually added to it.
• There is no evidence of a significant effect of theophylline infusion (Barr Rowe & Camargo 2003) [C] and its usage is not recommended. It may sometimes be used at a dose of 0.5 mg/kg/hour if response to other treatments is poor. Serum theophylline concentration should be monitored if possible.
• Methyl prednisolone 0.5 mg/kg every 6 hours is probably beneficial. Oral corticosteroids (prednisolone 30 to 40 mg/day) are used empirically for 7 to 14 days.

Acute Infection

• Antimicrobial treatment in an exacerbation of COPD is controversial. Factors that indicate starting antimicrobial treatment include:
  • Increased dyspnoea
  • Increased sputum
  • Purulent sputum
• If the patient exhibits two of the three symptoms listed above an antimicrobial drug is usually indicated (Ram et al. 2006) [A].
• Alternatives in antimicrobial treatment:
  • Amoxicillin 500 mg three times daily for 10 days
  • Doxycycline 150 mg once daily for 10 days
  • Sulfa-trimethoprim dose of trimethoprim 160 mg twice daily for 10 days.
• Antibiotics have no place in the basic maintenance therapy of COPD.

Improvement of Exercise Capacity

• Long-lasting regular and moderate exercise (Lacasse et al. 1996; Cambach et al. 1999) [A]

Vaccinations

• Influenza vaccination should be given yearly to all patients with clearly decreased ventilatory function (Poole et al. 2006) [B].
• Pneumococcal vaccination may be beneficial (Granger et al. 2006) [C].

Oxygen Therapy at Home

Basics

• Oxygen therapy at home can be used to prevent elevation of pulmonary arterial pressure in advanced COPD and to extend the life of the patient.
• The effect of oxygen therapy on symptoms (e.g. shortness of breath) is quite limited.
• Oxygen therapy at home is meant only for patients with chronic hypoxaemia (i.e. arterial desaturation).
• Treatment decisions should be made after critical consideration.
• When initiating oxygen therapy at home appropriate monitoring of treatment must be ensured. Treatment decisions and implementation of treatment should be the responsibility of the local pulmonary clinic.

Initiation Criteria for Oxygen Therapy

• Chronic advanced pulmonary disease (FEV₁ <1.5 L)
• The partial pressure of oxygen in arterial blood measured with the patient in stable phase of the disease breathing room air is <7.3 kPa in two samples taken with an interval of at least three weeks.
• Partial pressure of oxygen can also be 7.3 to 8.0 kPa if one of the following criteria is involved:
  • Signs of increased pulmonary arterial pressure (e.g. oedema)
  • Secondary polycythaemia (haematocrit >55)
  • Significant nocturnal hypoxaemia established by oximetry and reversible by oxygen therapy and not caused by concomitant sleep apnoea syndrome
  • Significant neuropsychological symptoms reversible by oxygen therapy
• Oxygen therapy gives the desired response (PaO₂ >8.0 kPa) without unfavourable increase in the partial pressure of carbon dioxide in arterial blood.
• The patient does not smoke and is sufficiently cooperative.

Implementation of Treatment

• Oxygen therapy at home is implemented in most cases using an electric oxygen concentrator. The oxygen concentrator eliminates nitrogen from room air and provides the patient with over 90%-proof oxygen.
• Portable liquid oxygen is suitable for a minority of patients. Primarily these are patients who are in the working life and/or who are motivated for rehabilitation through physical exercise.
• All oxygen therapy necessitates good cooperation by the patient and willingness for long-term cooperation with the treating unit.
• Home calls made by a rehabilitation instructor are an essential part of the monitoring of patients receiving oxygen therapy at home.

Definitions:

Levels of Evidence

1. Quality of Evidence: High

   Further research is very unlikely to change confidence in the estimate of effect

   • Several high-quality studies with consistent results
   • In special cases: one large high-quality multi-centre trial

2. Quality of Evidence: Moderate

   Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.

   • One high-quality study
   • Several studies with some limitations

3. Quality of Evidence: Low

   Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.

   • One or more studies with severe limitations

4. Quality of Evidence: Very Low

   Any estimate of effect is very uncertain.

   • Expert opinion
   • No direct research evidence
   • One or more studies with very severe limitations

Clinical Algorithm(s)

None provided

References Supporting the Recommendations

• Alsaeedi A Sin DD McAlister FA. The effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a systematic review of randomized placebo-controlled trials. Am J Med 2002 Jul;113(1):59-65. [33 references] PubMed



• Appleton S Poole P Smith B Cates C Veale A Bara A. Long-acting beta2-agonists for chronic obstructive pulmonary disease patients with poorly reversible airflow limitation. In: The Cochrane Database of Systematic Reviews [internet]. Issue 4. Hoboken (NJ): John Wiley & Sons Ltd.; 2001 [Art. No. CD001104].



• Barr RG Bourbeau J Camargo CA Ram FSF. Inhaled tiotropium for stable chronic obstructive pulmonary disease. In: The Cochrane Database of Systematic Reviews [internet]. Issue 2. Hoboken (NJ): John Wiley & Sons Ltd.; 2005 [Art. No. CD002876].



• Barr RG Rowe BH Camargo CA. Methylxanthines for exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2003;(2):CD002168. [43 references] PubMed



• Cambach W Wagenaar RC Koelman TW van Keimpema AR Kemper HC. The long-term effects of pulmonary rehabilitation in patients with asthma and chronic obstructive pulmonary disease: a research synthesis. Arch Phys Med Rehabil 1999 Jan;80(1):103-11. [64 references] PubMed



• de Marco R Accordini S Cerveri I Corsico A Anto JM Kunzli N Janson C Sunyer J Jarvis D Chinn S Vermeire P Svanes C Ackermann-Liebrich U Gislason T Heinrich J Leynaert B Neukirch F Schouten JP Wjst M Burney P. Incidence of chronic obstructive pulmonary disease in a cohort of young adults according to the presence of chronic cough and phlegm. Am J Respir Crit Care Med 2007 Jan 1;175(1):32-9. PubMed



• Granger R Walters J Poole PJ Lasserson TJ Mangtani P Cates CJ Wood-Baker R. Injectable vaccines for preventing pneumococcal infection in patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2006;(4):CD001390. [94 references] PubMed



• Highland KB Strange C Heffner JE. Long-term effects of inhaled corticosteroids on FEV1 in patients with chronic obstructive pulmonary disease. A meta-analysis. Ann Intern Med 2003 Jun 17;138(12):969-73. [16 references] PubMed



• Jones AP Rowe BH. Bronchopulmonary hygiene physical therapy for chronic obstructive pulmonary disease and bronchiectasis. Cochrane Database Syst Rev 1998;(2):CD000045. [7 references]



• Jones AP Rowe BH. Bronchopulmonary hygiene physical therapy for chronic obstructive pulmonary disease and bronchiectasis. Cochrane Database Syst Rev 2000;(2):CD000045. [7 references] PubMed



• Keenan SP Sinuff T Cook DJ Hill NS. Which patients with acute exacerbation of chronic obstructive pulmonary disease benefit from noninvasive positive-pressure ventilation? A systematic review of the literature. Ann Intern Med 2003 Jun 3;138(11):861-70. [46 references] PubMed



• Lacasse Y Wong E Guyatt GH King D Cook DJ Goldstein RS. Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. Lancet 1996 Oct 26;348(9035):1115-9. PubMed



• McCrory DC Brown CD. Anti-cholinergic bronchodilators versus beta2-sympathomimetic agents for acute exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2002;(4):CD003900. [44 references] PubMed



• Poole PJ Black PN. Mucolytic agents for chronic bronchitis or chronic obstructive pulmonary disease. In: The Cochrane Database of Systematic Reviews [internet]. Issue 1. Hoboken (NJ): John Wiley & Sons Ltd.; 2003 [Art. No. CD001287].



• Poole PJ Chacko E Wood-Baker RW Cates CJ. Influenza vaccine for patients with chronic obstructive pulmonary disease. In: The Cochrane Database of Systematic Reviews [internet]. Issue 1. Hoboken (NJ): John Wiley & Sons Ltd.; 2006 [Art. No. CD002733].



• Ram FS Jones PW Castro AA De Brito JA Atallah AN Lacasse Y Mazzini R Goldstein R Cendon S. Oral theophylline for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2002;(4):CD003902. [138 references] PubMed



• Ram FS Rodriguez-Roisin R Granados-Navarrete A Garcia-Aymerich J Barnes NC. Antibiotics for exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2006;(2):CD004403. [59 references] PubMed



• Ram FSF Picot J Lightowler J Wedzicha JA. Non-invasive positive pressure ventilation for treatment of respiratory failure due to exacerbations of chronic obstructive pulmonary disease. In: The Cochrane Database of Systematic Reviews [internet]. Issue 3. Hoboken (NJ): John Wiley & Sons Ltd.; 2004 [updated 2004 Mar 31]. [Art. No. CD004104]. PubMed



• Sestini P Renzoni E Robinson S Poole P Ram FS. Short-acting beta2 agonists for stable chronic obstructive pulmonary disease. In: The Cochrane Database of Systematic Reviews [internet]. Issue 3. Hoboken (NJ): John Wiley & Sons Ltd.; 2002 [Art. No. CD001495].



• van Grunsven PM van Schayck CP Derenne JP Kerstjens HA Renkema TE Postma DS Similowski T Akkermans RP Pasker-de Jong PC Dekhuijzen PN van Herwaarden CL van Weel C. Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis. Thorax 1999 Jan;54(1):7-14. PubMed

Type of Evidence supporting the Recommendations

Concise summaries of scientific evidence attached to the individual guidelines are the unique feature of the Evidence-Based Medicine Guidelines. The evidence summaries allow the clinician to judge how well-founded the treatment recommendations are. The type of supporting evidence is identified and graded for select recommendations (see the "Major Recommendations" field).

Potential Benefits

Appropriate management and treatment of chronic obstructive pulmonary disease (COPD) may help relieve patient symptoms improve exercise capacity improve lung function reduce morbidity and mortality improve quality of life and reduce frequency and severity of exacerbations.

Potential Harms

Adverse Effects of Medications

• Common adverse effects of oral long-acting theophylline include central nervous system and gastrointestinal symptoms. Arrhythmias and convulsions are signs of toxicity.
• Long-term use of oral steroids does not slow the decline in lung function and there is an increased risk of side-effects.

Description of Implementation Strategy

An implementation strategy was not provided.

IOM Care Need

Getting Better
Living with Illness

IOM Domain

Effectiveness
Patient-centeredness

Bibliographic Source(s)

• Finnish Medical Society Duodecim. Chronic obstructive pulmonary disease (COPD). In: EBM Guidelines. Evidence-Based Medicine [Internet]. Helsinki Finland: Wiley Interscience. John Wiley & Sons; 2007 Feb 7 [Various].

Adaptation

Not applicable: The guideline was not adapted from another source.

Source(s) of Funding

Finnish Medical Society Duodecim

Guideline Committee

Editorial Team of EBM Guidelines

Composition of Group that Authored the Guideline

Primary Author: Vuokko Kinnula

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Finnish Medical Society Duodecim. Chronic obstructive pulmonary disease (COPD). In: EBM Guidelines. Evidence-Based Medicine [CD-ROM]. Helsinki Finland: Duodecim Medical Publications Ltd.; 2005 Mar 2 [various].

Guideline Availability

This guideline is included in a CD-ROM titled "EBM Guidelines. Evidence-Based Medicine" available from Duodecim Medical Publications Ltd PO Box 713 00101 Helsinki Finland; e-mail: info@ebm-guidelines.com; Web site: www.ebm-guidelines.com.

Availability of Companion Documents

None available

Patient Resources

None available

NGC STATUS

This summary was completed by ECRI on December 17 2002. The information was verified by the guideline developer as of February 7 2003. This NGC summary was updated by ECRI on October 1 2004. This summary was updated by ECRI on December 5 2005 following the U.S. Food and Drug Administration (FDA) advisory on long-acting beta2-adrenergic agonists (LABA).This summary was updated by ECRI on March 14 2006 and again on November 12 2007.

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