Community COPD Service Protocol Acknowledgements This protocol is based on the following documents: 1. Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care, NICE, February 2004 2. Global strategy for the diagnosis, management and prevention of COPD (GOLD, 2007) 3. COPD Treatment Guide, Newcastle Primary Care Trust and Newcastle Hospital Trust, 2007 4. Management of Breathlessness and Exercise Limitations in Stable COPD, Easington Primary Care Trust, August 2006 Definition Chronic obstructive pulmonary disease (COPD) is a progressive disorder characterised by airflow obstruction. Airflow obstruction is defined as: Reduced forced expiratory volume in 1 second (FEV 1 ) where FEV 1 < 80% of predicted and Reduced FEV 1 to forced vital capacity (FVC) ratio where FEV 1 /FVC ratio <70% The airflow obstruction is usually progressive, not fully reversible and does not change markedly over several months. Most cases are caused by tobacco smoking, though on rare occasions lifelong non-smokers may develop COPD. Occupational exposures may also contribute to the development of COPD. Other diagnoses encompassed by COPD include; chronic bronchitis, emphysema and some cases of chronic asthma. Diagnosis There is no single diagnostic test for COPD meaning diagnosis relies on clinical judgement based on a combination of history, physical examination and the use of spirometry to determine the presence of airway obstruction. A diagnosis of COPD should be considered in patients over the age of 35 years with: Cigarette smoking history (usually) of more than 20 pack years History of exertional breathlessness, chronic cough, regular sputum production, wheeze Frequent winter bronchitis A full history and physical examination must be carried out confirming the diagnosis with lung function testing using spirometry. Page 1 of 8
Differential Diagnosis Middle aged smokers are also at high risk of lung cancer and ischaemic heart disease. COPD may coexist with either of these, or with asthma. A careful history and examination is important. Chest X-Ray and/or ECG are recommended to exclude lung cancer and cardiac problems if symptoms indicate their presence. Table 1 shows the clinical features differentiating COPD and asthma. Table 1: Clinical features differentiating COPD and asthma COPD Asthma Other Smoker or ex-smoker Nearly all No aetiological link, but Lung cancer exacerbating factor Symptoms under age Rare Common of 35 Chronic cough with Common Uncommon sputum Presence of atopy Uncommon Common Breathlessness Persistent and Variable progressive Haemoptysis Uncommon Not a feature Lung cancer Excessive purulent Common Scanty sputum Possible bronchiectasis sputum Night-time waking with Uncommon Common breathlessness/wheeze Significant diurnal variability of symptoms Uncommon Common Refer to specialist clinic for diagnosis or intervention if: Symptoms are disproportionate to lung function deficit Haemoptysis Rapid decline in FEV 1 (>200ml in 1 year) <35 years of age PMH or FH of alpha-1-antitrypsin deficiency Onset of cor pulmonale Page 2 of 8
Spirometric Diagnosis Patients who are: Over 35 years of age Smokers or ex-smokers Have any of the following symptoms: o Exertional breathlessness o Chronic cough o Regular sputum production o Frequent winter bronchitis o Wheeze And have no clinical features of asthma (see table 1, pg 2) Perform spirometry if COPD seems likely from history and physical examination. Airway obstruction defined as: FEV 1 <80% of predicted and FEV 1/FVC ratio <70% If still in doubt about diagnosis: If no doubt, diagnose COPD and start treatment depending upon severity (assessed using FEV 1 ratio) COPD is not present is FEV 1 and FEV 1/FVC ratio return to normal with drug therapy Asthma may be present if: o There is > 400ml response to bronchodilators (perform bronchodilator reversibility testing) o Serial peak-flow measurements show diurnal variation or day-to-day variability Refer for more detailed investigations if needed Adapted from NICE Guidelines for COPD, Feb 2004 Procedure for performing spirometry: Ensure spirometer is clean and calibrated Attach a clean, disposable one-way mouthpiece to the spirometer Explain the procedure to the patient checking contraindications Enter patient information (height, weight, age) into spirometer Patient should be seated in a chair with arms for support. Ensure no restrictive clothing Patient should be advised to seal lips and teeth around mouth piece Perform three relaxed vital capacities (using nose clip) Relaxed blows to be within 5% or 100mls of each other Patient to perform three reproducible forced expiratory manoeuvres o Clasp lips and teeth around mouthpiece o Blow as hard and as fast as possible into the mouthpiece o Continue to blow for as long as possible o Allow 30 seconds between blows o Ensure reproducibility, minimum three blows within in 5% or 100mls of each other Print copy of results Sign results for verification (Spirometry in Practice, Second edition, 2005) Page 3 of 8
Contraindications for spirometry: Presence of uncontrolled angina Pneumothorax in past 8 weeks MI in past 8 weeks Presence of uncontrolled hypertension Presence of hemoptysis Recent PE Recent surgery of thorax, abdomen or eye Presence of thoracic, abdominal or cerebral aneurysms Infection control: A new disposable one way mouthpiece must be used for each patient. After carrying out spirometry this mouthpiece must be immediately removed and discarded. Hands must be washed with hot soapy water after contact with the used mouthpiece. The handheld section of the spirometer must be wiped down with an antibacterial wipe (e.g. Azo Wipe) between patients. The handheld section must be dismantled and washed with warm soapy water after each session and left to dry before reconstruction and reuse. Spirometric diagnosis general notes: Spirometer to be calibrated weekly using calibration syringe Record calibration on spreadsheet Training and monitoring of spirometry technique mandatory o Spirometry must be carried out by a pharmacist accredited in spirometry (Current qualified staff have accreditation from Respiratory Education UK) o All qualified staff must be committed to undertaking CPD All references to spirometry imply the best of 3 blows Severity of obstruction will be based on FEV 1 ratio (NICE, 2004): o Mild: FEV 1 50-80% of predicted o Moderate: FEV 1 30-46% of predicted o Severe: FEV 1 <30% of predicted If bronchodilator reversibility testing is necessary then the following procedure should be adopted: 1. Bronchodilator reversibility testing should be carried out at the same time as diagnostic spirometry (if convenient to patient). Otherwise ask the patient to return on another occasion and to avoid bronchodilators (β2-agonists/ antimuscarinics) for the previous 6 hours (or 12 hours for LABAs). 2. Administer 400-600mcg (4-6 puffs) of salbutamol via volumatic 3. Wait 30 minutes 4. Repeat spirometry 5. Calculate the increase in FEV 1 Page 4 of 8
Treatment Guidelines 1. Non-pharmacological Smoking cessation Exercise Pulmonary rehabilitation Nutrition Weight reduction if BMI >25 Vaccination (pneumococcal and annual influenza) 2. Pharmacological Age >35 years with risk factors Spirometry FEV 1/FVC ratio <70% and no evidence of asthma COPD FEV 1 > 50% of predicted Mild Moderate/ severe FEV 1 < 50% of predicted Intensive Smoking Cessation Inhaled short acting bronchodilator (s) salbutamol 100mcg 2 puffs QDS PRN and/or ipratropium 20mcg 2 puffs 3-4 times a day Symptoms not controlled Combination therapy salbutamol 100mcg 2 puffs QDS PRN tiotropium 18mcg od seretide accuhaler 500mcg 1 puff BD OR symbicort 400/12 1 puff BD Pulmonary Rehabilitation Tiotropium trial Spiriva 18mcg 1 puff OD Measure FEV 1 6 weeks after starting Pulmonary Rehabilitation Reassess Diagnosis Page 5 of 8
Intensive smoking cessation: Smoking cessation is the most important intervention when treating COPD. Smoking cessation should be the principle focus following a diagnosis of COPD. Patients should be referred to the nearest NHS stop smoking service for intensive support. Short acting bronchodilators: There is very little evidence to distinguish between the use of salbutamol or ipratropium; both are equally effective. Salbutamol is however less expensive. There may be additional benefits from using the two in combination. Nebulisers do not offer advantages over MDIs given via a spacer. Tiotropium: When starting tiotropium it is important to discontinue ipratropium. When using tiotropium in patients where FEV 1 >50%, if there is no improvement in symptoms after six weeks the drug should be stopped. In patients with FEV 1 <50% of predicted tiotropium is proven to reduce exacerbation frequency and should be continued long term. Inhaled steroids: Inhaled steroids have been shown to reduce exacerbation frequency in patients with FEV 1 <50% of predicted 1,2. The evidence favours combination inhalers over single agent inhaled steroids 3. The combination inhalers Symbicort and Seretide (via accuhaler) are the only licensed inhaled steroids for COPD. The evidence supports high dose 3. This could either be Symbicort 400/12 one puff BD or Seretide 500mcg accuhaler one puff BD. Pulmonary rehabilitation: Pulmonary rehabilitation is one of the most effective interventions for patients limited by breathlessness. Pulmonary rehabilitation should be offered to appropriate patients with a classification of moderate disease or worse (usually MRC grade 3 or above). Pulmonary rehabilitation has been carefully evaluated in a large number of clinical trials and there is now Grade A evidence to support its use 4,5. Data suggests that the benefits gained from a single pulmonary rehabilitation programme can be sustained providing the exercise is maintained at home 6. Mucolytics A trial period of a mucolytic agent is recommended for patients with a chronic productive cough or frequent exacerbations. Mucolytic therapy is associated with improved symptoms and a reduction in exacerbations. Page 6 of 8
Self management of acute exacerbations Patients at risk of acute exacerbation should be educated to self manage their exacerbations as soon as symptoms occur. Patients should have a reserve supply of oral prednisolone and antibiotics. If two or more of the following are present: Increased sputum volume Purulent sputum Increased dyspnoea Then: Increase bronchodilator if on PRN to regular QDS doses Start oral prednisolone 30mg OD for seven days Start antibiotics: Amoxicillin 500mg TDS for five days or oxytetracycline 250mg QDS for seven days (if allergic to penicillin). If allergy to penicillin and tetracycline then erythromycin 500mg QDS should be given 7. (Adapted from SIGN Guideline 59: Community management of lower respiratory tract infection in adults. Secti0on 4: Exacerbations of COPD and Durham PCT: Summary of Antibiotic Guidance for Primary Care, November 2007 Patients should assess their exacerbation using the form Your COPD Self-Management Plan following the given instructions. Patients should contact a healthcare professional if their symptoms do not improve. Annual Review An annual review must be conducted and should include: History o Review of symptoms o Compliance/concordance with medication o Changes in: Smoking history Exercise levels Weight o Relevant social issues Examination o Height o Weight o BMI o Spirometry o Inhaler technique Management o Lifestyle advice o Referral to smoking cessation o Immunization o Change of medication in accordance with treatment guidelines Referral to the GP: o Symptoms are disproportionate to lung function deficit o Symptoms not adequately controlled on medication o Haemoptysis o Rapid decline in FEV 1 (>200ml in 1 year) o Symptoms of chest infection Page 7 of 8
References 1. Alsaeedi A., Sin D.D., McAlister F.A., 2002. The effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a systemic review of randomized placebocontrolled trials. Am J Med. 2002 Jul;113(1):59-65 2. Burge S., 2001. Should inhaled corticosteroids be used in the long term treatment of chronic obstructive pulmonary disease? Drugs. 2001;61(11):1535-44 3. Are Seretide and Symbicort useful in COPD?. DTB. 2004;42:18-21 4. British Thoracic Society, 2001. Pulmonary rehabilitation: Statement. Thorax 56: 827-834 5. Berry M.J., Rejeski W.J., Adair N.E., Zaccaro D., 1999. Exercise rehabilitation and COPD stage. Am J Respir Crit Care Med 163:1256-1276 6. Griffiths T.L., Burr M.L., Campbell I.A., et al., 2000. Results at one year of outpatient multidisciplinary pulmonary rehabilitation: a randomised controlled trial. Lancet 355: 362-8 7. Scottish Intercollegiate Guidelines Network. Guideline 59. Community Management of Lower Respiratory Tract Infection in Adults. Section 4: Exacerbations of COPD. http://www.sign.ac.uk/guidelines/fulltext/59/section4.html [accessed 09/04/08] Page 8 of 8