Pt received RSV/Placebo and Influenza vaccine on 10/15/02 and 4 hrs later developed severe dyspnea with minimal activity and COPD exacerbation. Pt reported difficulty in sleeping due to dyspnea. On 10/17/02, the pt reported symptoms to the pulmonary physician, principal investigator, and study coordinator. On 10/18/02, pt was diagnosed with COPD exacerbation at the ER. On 10/19, pt reported sleeping more comfortably, but labored breathing and decreased volume capacity continues as of 10/24. On 10/24, reported difficulty in sleeping (sleeping in chair). Treatment included Albuterol Nebulizer and Prednisone tapering. Currently on Prednisone 30mg per day. On 10/29/02, pt visited pulmonary physician who provided the following additional info: Pt has a progressive hisotry of worsening SOB on exertion for past 2-3 years. Became more pronounced after an episode of pneumonia in April 2001 and 2nd episode April 2002. Became very SOB when carrying any weight e.g. boxes. Not prednisone dependent and never intubated. On 8/20/02, pt called and complained of SOB and cough and sputum. Resolved with antibiotics. On 10/29/02 complained of severe SOB. Denied worsening cough, increased sputum or fever. Dramatic deterioration of pulmonary status with decrease in FEV 1 from 0.9 to 0.52 and severe SOB. No evidence of acute bacterial infection, no increase in cough, sputum, (recent CXR after symptoms showed no infiltrates). Prescribed higher dose of prednisone for longer period 40mg daily for 2 weeks. On 11/12/02 pt saw pulmonary physician who reports that there is no improvement with prednisone in fact breathing may be slightly worse this week. Has developed "minimal" lower extremity edema with the prednisone. Pt denies chest pain. Pulmonary physician states "concerned of a rapidly progressive obstructive disease other than COPD; a possibility would be constructive bronchiolitis or even panbronchiolitis." Due to new onset of pitting edema, cardiac function will be evaluated. CT of the chest with high resolution cuts, and echocardiogram will be scheduled. Follow-up info received 11/26/02: CT chest W&W/O Contrast: In the left lower superior segment, image 28, there is nodular hazy ground glass opacity peripherally located. This area has some bronchiectasis on high resolution images and may be a focal area of fibrosis. However, findings are non-specific and a BAC nodules or masses are seen. There are multiple, small, less than 1cm mediastinal lymph nodes. Extensive coronary artery and vascular calcifications are noted. There are no significant focal areas of air trapping. There is mild bronchiectasis. No pleural effusions. No suspicious bony lesions. Images of the upper abdomen appear grossly normal. Impression: 1. Small, hazy peripheral opacity in the left lobe superior segment with postinflammatory scarring. However given a bronchial alveolar cell carcinoma could appear similar, a 3 month follow-up study is recommended. Severe centrilobular eymphysema and mild bronchiectasis. Extensive coronary artery calcifications. Cardio echo preliminary report: The aortic root and valve appear normal without AI. The left atrium appears dilated by 20 apical imaging. The left ventricle appears normal in wall thickness, chamber size and systolic function. The right heart appears normal in size and function. There is tract TR. There is no pericardial effusions. Pulmonary function test 11/12/02: Summary: severe airflow obstruction and improvement after inhaled bronchodilators. No significant change since last testing. Follow-up info received 12/5/02: Pulmonary physician visit of 12/3/02-Physician states "This fall pt experienced a dramatic worsening in symptoms, associated with a significant decrease in FEV 1. He failed a trial of prednisone, but after we initiated treatment with nebulized albuterol and Atrovent BID and Fluticasone BID, he now feels better, and interestingly the FEV 1 has increased to 0.60. Comes today for routine f/u. HEENT: Nasal and oral mucosa moist; lung: moving more air than on previous visits. B/L rales. Heart: RRR no murmurs. EXT: no cyanosis, 1+ edema b/l. FEV 1 has established with current treatment. Will continue present regime and repeat a CT scan in 3 months as suggested by radiology. Will also refer to ophthalmology at pt's request. Site coordinator reports on 12/5/02, subject called to report a constant dull deep pain behind right shoulder blade in the right lung area. Subject denies URI or any physical activity that would cause this pain, denies chest pain, neck pain or pain down either arm. Subject reports continued difficulty breathing. Was advised to see physician. Subject called site coordinator to report that he has an appointment 12/5/02. Follow-up info is expected. Follow-up info received 12/13/02/PCP progress notes: 12/3/02-CXR-no pneumonia. WBC is 23-wondering if pt was on steroids or any other RX. He is responding to nebulizer well, will continue to monitor. 2/5/02-experiencing sharp pain in right scapular area with deep breathing. Speaking in whole sentences. Has good 02 sat. (92% on room air). Chest is clear to auscultation. T 98; P 66; BP 158/70; PO2 92% RA. CXR reveals emphysema-no infiltrates. Pleuritic chest pain, prescribed Celebrex 200mg-qid and oxycodone 3/Acet 1q 4-6h prn. Follow-up info received 3/31/03: Pulmonary function test. Interpretation: Spirometry: severe reduction of airflow rates (FEV1 and FEF 25-75) and FEV1/FVC, indicating airflow obstruction. Bronchodilator response: airflow improves by 13% after inhaled bronchodilators. Lung volumes: reduced SVC, indicating either restriction, or air trapping. Other lung volumes were not measures. Blood gases: none. Summary/impression: Severe airflow obstruction and improvement after inhaled bronchodilators. Pulmonary phone contact note 3/20/03: Pt went to his primary MD, who prescribed home oxygen. His oxygen sat was "89 to 90 at rest, and then about 89 when walking." Both the pt and his caretaker, think that he is feeling better with the oxygen. The physician will put a consult to home O2 at the VA (clinic), although in the clinic he has not met criteria for home O2." From CT chest 3/26/03: clinical history: 66 year old smoker with COPD would like to perform a follow-up CT scan; pt had a previous CT in December read as "images that could be c/w BAC, suggest follow-up in 3 months." Report: comparison: CT of thorax performed 11/15/02. Findings: As before, there is severe centrilobular emphysema diffusely and bilaterally. Previously noted are of high attenuation in left lower lobe superior segment is unchanged in size and has a centrally located 5mm nodule as well as multiple linear components, which are consistent with fibrosis or intersititial disease. In addition there are new focal linear areas of consolidation, likely scar or atelectasis in right lower lobe and the lingula, which favor radiographic appearance of fibrosis more than airspace disease. As before, there are multiple small sub-centimeter mediastinal lymph nodes. In addition there is a soft tissue nodule in the subcarinal region measuring 14mm, previously 13mm, which may represent scar and/or lymph nodes. No pleural effusion. Heart size is normal. NO pericardial effusion. Once again, there is extensive coronary artery and vascular caldification. The bones are unremarkable. visualized portions of the upper abdomen are normal. The pt is status post cholecystectomy. Impression: 1. Stable left lower lobe linear interstitial scarring with mild centrilobular component. New right lower lobe and lingular interstitial disease and fibrosis. If continued clinical concern, additional imaging to demonstrate stability over 24 months is recommended. An imaging schedule of 6 months, 12 months and 24 months after initial scan would be reasonable. No evidence of progression of left lower lobe nodule to suggest bronchioalveolar carcinoma. 2. Severe centrilobular emphysema. 3. Extensive coronary artery and vascular calcification, indicating atherosclerosis. The investigator assessed the event as probably related to the study product. Follow-up info received 4/9/03. Pulmonary outpatient visit note 6/4/02: 66 y/o man with hx of emphysema whose care is being transferred to the VA from HMC, where he was being followed by physician. Also has a primary care MD. The pt is currently at his respiratory baseline and comes to establish care here at the VA. Background: Smoking history of 100pack/years, quit 4/4/02 with hypnosis. Has had progressive history of worsening SOB on exertion for the past 2-3 years, which has become more pronounced after an episode of pneumonia in 4/01 and a second episode in April 2002. Otherwise has never been intubated and is not of pneumonia in April 2001 and a second episode in April 2002. Otherwise has never been intubated and is not prednisone/dependent. Bronchodilator requirements: Combivent PRN, uses 1 canister/month approx. Prednisone responsiveness: FEV 1 increased from 0.910L to 1.110L after 2-week prrednisone trial in April 2001; not associated with symptomatic improvement. Has also postnasal dripping controlled with Claritin and Flonase; no symptoms of GERD. Baseline: currently can walk on flat ground without stopping, can do one flight of stairs but becomes very SOB when carrying any weight like boxes etc. Has no night symptoms, minimal cough/ sputum not prednisone/O2 dependent. Meds: Combivnet 2 puffs qid prn, Claritin, Flovent 2 puffs BID. All: NKDA. PMH: COPD, FEV1=0.9, cholecystectomy 1984, TIA 1996, heart flutter. Social: pets: 1 dog, no cats, no birds. Allergic to pollens. Retired. Physical exam: no actute distress. Mild SB when walking to the office from waiting room. Wt 147 lbs BP 157/76 HR83 Pox 95% RA. HEENT: oropharynx and nasopharynx clear without discharge/ lesions. Neck: soft, supple, no bruits/masses. Heart: no gallop, murmurs. Lungs: diffusely decreased breath sounds. Abd soft nontender. Et: no edema. No cyanosis, clubbing. COPD major goals are: 1. decrease breathlessness if possible; 2. prevent additional loss of lung function. Goal: 1. will continue present treatment with combivent and Fluticasone. The pt has not been using the fluticasone regularly because of problems of access to the medication, now he will receive it thru the VA. If the current therapeutic regime results in no symtomatic improvement, will consider low dose theophylline during the next visit. Will check oxymetry on exertion next visit. Goal 2: prevent additional loss of lung function. Will give a course of antibiotics to the to keep at home and use in the event of another exacerbation. Encouraged the pt to use regularly his medications for post-nasal drip (flonase and claritin) which he has been using sporadically. Will check PFT and CXR prior to next visit as a baseline for our clinic. Next appointment: 6 months. Pulmonary phone contact note 8/20/02. Pt called to day reporting increase in coughing and more phlegm being produced in gray color. Per doctor he has been instructed to start taking azithromycin and call me on Friday with update on how he is feeling. If he is getting worse he should go to the PEC. If feeling better he needs to come to pulmonary clinic on 9/3 for follow up. Pulmonary phone contact note 4/4/03. Called the pt to notify him of the official CT results. He is aware of his appointment next week. He has stopped all his oral medications-including metoprolol and theophylline-because they were "doing nothing," and he says that he now "feels better." He would like me to write a letter to the utilities companies, which are threatening with cutting his services. I will place a request for a primary care physician here at the VA, because it appears that his contacts with his MD are minimal and he definitely needs a PCP coordinating his care. Follow up info received 4/29/03: Medical records of subject covering period 3/2701 to 3/12/02 prior to the event in the study are attached. Follow up info received 5/5/03. Medical records of subject covering period 1989t o 3/25/03 are attached. Follow up info received 6/16/03: Pulmonary outpatient visit note on 6/14/03. This is a routine follow-up for this 67 year old male followed up for severe COPD. Previous clinic visit: 3/7/03. Recent events: Today pt says that his breathing is worse. He mentioned that his former caretaker, is no longer with him, and complains that "caretaker left a stole money" from him. Pt also complains that "some of his pills from the VA were stolen." He is very upset because we are giving him "an antidepressant," referring to the trazodone. When I explained that the trazodone was being prescribed to help with anxiety and with sleep, he said that he had never had problems with anxiety of sleep-despite having mentioned the opposite in previous visits. Pt also asked me about his recent appointment with social services, and mentioned the "he had always been compliant with all his medications," and denied having ever stopped taking any meds. PE: BP: 154/64, HR 72, Pox=99% RA. NAD: Today pt can speak full sentences without SOB. Lungs: breath sounds bilaterally, scattered rales. Heart: ERR no murmurs. EXT: no cyanosis. Echo 11/15/02: N1 LV function, no PASP noted. CT chest 11/15/02: 1. Small hazy peripheral opacity in the left lobe superior segment with areas of bronchiectasis. Imaging findings are nonspecific; however, likely represent fibrosis or postinflammatory scarring. However, given a bronchial alveolar cell carcinoma could appear similar, a three-month follow up study is recommended. 2. Severe centrilobular emphysema and mild bronchiectasis. 3. Extensive coronary artery calcifications. A/P: 1. Severe COPD without hypoxemia or pulmonary hypertension. FEV1 is markedly improved today. After his last visit, we had consider adding serevent-however I am a little unsure about modifying his medication regime, not only because his FEV1 is improving, but also to avoid further complicating his medication regime. I am concerned that over time, there has been discrepancies re. the medications that pt admits to be taking, and also that the pt has again declined home help. Will follow up in 3-4 months. Repeat CT scan is due in Sep/Nov. Pulmonary function test from 6/10/03 with source documents. Additional info received 8/27/03. Pulmonary telephone contact note: 7/21/03. Subject called today. He has visited doctor, a community pulmonologist, who repeated the PFT and prescribed some new medications, including QVAR and  other medications. Subject has requested doctor to get in contact with us. Otherwise, he is feeling very well today. Health promotion screening note 7/31/03. 67 y/o male seen at VA cooperative health screening by internist who documented the following per his chart note as follows: PMH: COPD. Denies h/o htn, cancer, etoch abuse, DM, PVD, subs abuse. PSHx: chole, pinal cyst removed. Meds: Albuteral MDI, Atrovent MDI, ALL: NKA. SHx: 1pppd smoker. Fhx: mother w/DM. ROS: dyspnea, ?nocturia, otherwise neg. O:T: 96.6 BP: ras 176/118 LAS 200/102 P: 69R: 24 HT 147 lbs HT 68". PE: CVS: S1S2, tachy RR, no m/g/r. C/L: symmetrical chest expansion, harsh exp wheezing. Ext: DP 2+, no c/c, 3mm edema. Rectal: deferred. ECG today-NSR; PR 166 QRSD 67 QT 387 QTc 411 P 84 QRS 76 T 83. A/P 1. Severe COPD, recommended close plum f/u, may required O2 in future, f/u plum VA 26th as planned, Pneumovac today, needs PCM. 2. blepharitis, Augmentin 500mg bid #20. 3. Eczema, f/u w/ PMD as planned. Concur w/ above, Augmentin 500mg bid x 10 days ordered to be mailed ASAP. Pharmacy general progress note 8/1/03: Saw subject for pharmacy care. Allergy info: NKDA; says he was injected with something and his breathing capacity went below 15%. Meds: Augmentin 500mg BID-Rx from clinic, pls mail to pt ASAP; pls contact pharmacy finish the Rx when the order in placed in the computer to expedite delivery. A/P: pt says that he also gets Foradil form outside, not sure the name exactly. Informed pt to call in to the pharmacy and let me know what other meds he is on from outside. Pulmonary outpatient visit note 8/26/03: Same as for 6/14/03 with addition of FEV1 ranges from 0.49 to 0.99. Not Prednisone/O2 dependent. Medications: Medications prescribed available in source documents. Recent events: Last visit, we noticed the subject FEV1 had improved to 0.99 up from 0.49 in April. We had initially planned to start him on Serevent, but didn't do so because FEV1 was improving, and I did not want to make his medication regime more confusing because I have been extremely concerned about his compliance with medications. At any rate, following his last visit subject visited pulmonologist. Pulmonoglosit's impression was "end-stage emphysematous lung disease" and prescribed QVAR, Formoterol and DuoNebs. As per their notes, which were faxed to me, Pulmonologist was aware that subject has prescribed nebs and fluticasone. Comes today to a routine visit. Today he is very pleasant. He continues to be worried about the sudden increased in FEV1 from 0.49 to 0.99 because he thinks that such as abrupt change must be a technical mistake and complained that "he continues to be very sick, even though the test suggest he is getting better." I emphasized that his COPD is "severe" in either test, and that there will be variability from test to test, and in any case his treatment remains the same. Subject also mentioned that he has noticed some improvement with the combination of Albuterol and Atrovent, and also mentions that he is requiring less Albuterol MDI with the Formoterol. He has not been using the QVAR. Today subject can speak full sentences without SOB. Lungs: breath sounds bilaterally, scattered rales, today has wheezing on left lung field. Heart: RRR no murmurs. EXT: no cyanosis. A/P 1. Severe COPD without hypoxemia or pulmonary hypertension. Now that he has two pulmonologist, I am even more concerned that before re: medication compliance, although he mentions that his primary pulmonary care will remain with us. Will add Formoterol and Atrovent/Albuterol nebs, because these seem to have improved. Abnormal CT scan with possible BAC. Bronchiectasis stable. Follow up on 02/13/04 states: "Additional information received 02/05/04.  No further information is available on this subject at this time. This subject was withdrawn from the study on 05/07/03 and last date of contact was dated 10/08/03.  The consent form did not allow further access to medical records.  Additional information received and available in source file: letter from department dated 02/03/04." Follow up 12/06/04: Patient recovery status unknown.