scholarly journals The Addition of Salmeterol 50 µg Bid to Anticholinergenic Treatment in Patients with COPD: A Randomized Placebo Controlled Trial

2002 ◽  
Vol 9 (3) ◽  
pp. 178-185 ◽  
Author(s):  
Kenneth R Chapman ◽  
Peter Arvidsson ◽  
AG Chuchalin ◽  
DP Dhillon ◽  
Peter Faurschou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Controlled Trial ◽  
Airflow Obstruction ◽  
Chronic Obstructive ◽  
Anticholinergic Medication ◽  
Anticholinergic Therapy ◽  
Symptom Scores ◽  
Baseline Levels

BACKGROUND: In the past, the role of long-acting beta2-agonists in chronic obstructive pulmonary disease (COPD) relative to other agents has been unclear.OBJECTIVES: To compare the effect of adding salmeterol (50 µg bid) or placebo to concurrent anticholinergic therapy on symptom scores, quality of life, prebronchodilator lung function and exacerbations in patients with moderately severe COPD.METHODS: This was a double-blind, randomized, parallel-group study in patients aged 40 years or older receiving anticholinergic medication. Patients were randomly assigned to treatment with placebo (n=207) or salmeterol (n=201) via a Diskus/Accuhaler inhaler for 24 weeks.RESULTS: The morning trough (prestudy drug) forced expiratory volume in 1 s (FEV1) increased significantly above baseline levels among the salmeterol-treated patients. Improvement in FEV1was greater in the salmeterol group than in the placebo group at four weeks (difference 0.06 L, P <0.005), eight weeks (0.06 L, P <0.005) and 16 weeks (0.05 L, P <0.05) after the start of treatment. There was a nonsignificant trend in favour of salmeterol after 24 weeks of treatment (P=0.198). Improvements in morning peak flow were significantly greater in the salmeterol group over 24 weeks (P <0.01). Although symptom scores were numerically higher in the salmeterol group than in the placebo group and there was less requirement for rescue bronchodilator use, these differences were not statistically significant. In the salmeterol group, fewer patients had exacerbations of COPD, and there was a trend toward an improved quality of life. The safety profile of the two groups was similar.CONCLUSIONS: Salmeterol has a beneficial effect when added to existing anticholinergic therapy in patients with COPD. The regular use of salmeterol for six months was not associated with worsening of the underlying airflow obstruction; rather, there was a tendency for the trough FEV1to improve above the baseline levels over the treatment period.

scholarly journals Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025692 ◽  
Author(s):  
Corita R Grudzen ◽  
Deborah J Shim ◽  
Abigail M Schmucker ◽  
Jeanne Cho ◽  
Keith S Goldfeld
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Randomised Controlled ◽  
End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

Inspiratory muscle training does not improve clinical outcomes in 3-week COPD rehabilitation: results from a randomised controlled trial

2018 ◽  
Vol 51 (1) ◽  
pp. 1702000 ◽  
Author(s):  
Konrad Schultz ◽  
Danijel Jelusic ◽  
Michael Wittmann ◽  
Benjamin Krämer ◽  
Veronika Huber ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Inspiratory Muscle ◽  
Inspiratory Muscle Training ◽  
Chronic Obstructive ◽  
Muscle Training ◽  
Randomised Controlled

The value of inspiratory muscle training (IMT) in pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) is unclear. The RIMTCORE (Routine Inspiratory Muscle Training within COPD Rehabilitation) randomised controlled trial examined the effectiveness of IMT added to pulmonary rehabilitation.In total, 611 COPD patients (Global Initiative for Chronic Obstructive Lung Disease stage II–IV) received a 3-week inpatient pulmonary rehabilitation, of which 602 patients were included in the intention-to-treat analyses. The intervention group (n=300) received highly intensive IMT and the control group (n=302) received sham IMT. The primary outcome was maximal inspiratory pressure (PImax). The secondary outcomes were 6-min walk distance, dyspnoea, quality of life and lung function. Outcomes were assessed pre- and post-pulmonary rehabilitation. ANCOVA was used.The intervention group showed higher effects in PImax (p<0.001) and forced inspiratory volume in 1 s (p=0.013). All other outcomes in both study groups improved significantly, but without further between-group differences. Sex and pulmonary rehabilitation admission shortly after hospitalisation modified quality of life effects.IMT as an add-on to a 3-week pulmonary rehabilitation improves inspiratory muscle strength, but does not provide additional benefits in terms of exercise capacity, quality of life or dyspnoea. A general recommendation for COPD patients to add IMT to a 3-week pulmonary rehabilitation cannot be made.

The Effect of Aromatherapy on Sleep and Quality of Life in Menopausal Women with Sleeping Problems: A Non-Randomized, Placebo-Controlled Trial

2020 ◽  
Vol 27 (6) ◽  
pp. 421-430
Author(s):  
Meryem Gürler ◽  
Aynur Kızılırmak ◽  
Mürüvvet Baser
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Sleep Quality ◽  
Controlled Trial ◽  
Intervention Group ◽  
Placebo Control ◽  
Life Questionnaire ◽  
Menopausal Women ◽  
Sleeping Problems

<b><i>Introduction:</i></b> Menopause is the termination of menstruation and fertility. Women commonly experience sleeping problems during the menopausal period. Aromatherapy is among the complementary therapies used to remedy sleeping problems. <b><i>Methods:</i></b>This study aims to investigate the effects of lavender oil on sleep and quality of life of menopausal women through steam inhalation. This study was quasi-experimental with pre-test/post-test placebo control groups. It was conducted with 57 women, 27 of whom were subject to aromatherapy and 30 to a placebo. Data were collected using the Questionnaire Form, the Pittsburgh Sleep Quality Index (PSQI) and the Menopause-Specific Quality of Life Questionnaire (MENQOL). <b><i>Results:</i></b> For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (<i>p</i> &#x3c; 0.001) and those of the placebo group (<i>p</i> &#x3c; 0.001). Similarly, for the intervention group, the total median MENQOL scores after the administration of the aromatherapy were found to be significantly lower than the scores prior to the administration (<i>p</i> &#x3c; 0.001) as well as the scores of the placebo group (<i>p</i> &#x3c; 0.001). <b><i>Conclusion:</i></b> It was found that aromatherapy involving lavender-scented steam inhalation increased sleep quality and quality of life in women with sleep deprivation problems during menopause.

scholarly journals Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246871
Author(s):  
Timna Naftali ◽  
Lihi Bar-Lev Schleider ◽  
Fabiana Scklerovsky Benjaminov ◽  
Fred Meir Konikoff ◽  
Shelly Tartakover Matalon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Placebo Group ◽  
Activity Index ◽  
Controlled Trial ◽  
Clinical Effects ◽  
Short Term Treatment ◽  
Double Blind ◽  
Endoscopic Score

Background Cannabis is often used by patients with ulcerative colitis, but controlled studies are few. We aimed to assess the effect of cannabis in improving clinical and inflammatory outcomes in ulcerative colitis patients. Methods In a double-blind, randomized, placebo-controlled trial, patients received either cigarettes containing 0.5 g of dried cannabis flowers with80mgTetrahydrocannabinol (THC)or placebo cigarettes for 8 weeks. Parameters of disease including Lichtiger disease activity index, C reactive protein (CRP), calprotectin, Mayo endoscopic score and quality of life (QOL) were assessed before, during and after treatment. Results The study included 32 patients. Mean age was 30 years, 14 (43%) females. Lichtiger index improved in the cannabis group from 10.9 (IQR 9–14) to5 (IQR 1–7), (p<0.000), and in the placebo group from 11 (IQR 9–13) to 8 (IQR 7–10)(p = 0.15, p between groups 0.001). QOL improved in the cannabis group from 77±4 to 98±20 (p = 0.000) but not in the placebo group (78±3 at week 0 and 78±17 at week 8;p = 0.459; p between groups 0.007). Mayo endoscopic score changed in the cannabis group from 2.13±1 to 1.25±2 (p = 0.015) and in the placebo group from 2.15±1to 1.69±1 (p = 0.367, p between groups 0.17). Conclusion Short term treatment with THC rich cannabis induced clinical remission and improved quality of life in patients with mild to moderately active ulcerative colitis. However, these beneficial clinical effects were not associated with significant anti-inflammatory improvement in the Mayo endoscopic score or laboratory markers for inflammation.(clinicaltrials.gov NCT01040910).

scholarly journals A Telemonitoring and Hybrid Virtual Coaching Solution “CAir” for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial

10.2196/20412 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e20412
Author(s):  
Christoph Gross ◽  
Dario Kohlbrenner ◽  
Christian F Clarenbach ◽  
Adam Ivankay ◽  
Thomas Brunschwiler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Health Related Quality ◽  
Obstructive Pulmonary Disease ◽  
Virtual Coaching ◽  
Randomized Controlled ◽  
Related Quality ◽  
Health Related

Background Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. COPD is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in the health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve patients’ disabilities. Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention. Objective This study aims to develop a comprehensive telemonitoring and hybrid virtual coaching solution and to investigate its effects on the health-related quality of life of patients with COPD. Methods A monocentric, assessor-blind, two-arm (intervention/control) randomized controlled trial will be performed. Participants randomized to the control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching. Participants randomized to the intervention group will receive a CAir Desk and a hybrid digital coaching intervention for 12 weeks. As a primary outcome, we will measure the delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire, from baseline to week 12 (the end of the intervention). Results The development of the CAir Desk and virtual coach has been completed. Recruitment to the trial started in September 2020. We expect to start data collection by December 2020 and expect it to last for approximately 18 months, as we follow a multiwave approach. We expect to complete data collection by mid-2022 and plan the dissemination of the results subsequently. Conclusions To our knowledge, this is the first study investigating a combination of telemonitoring and hybrid virtual coaching in patients with COPD. We will investigate the effectiveness, efficacy, and usability of the proposed intervention and provide evidence to further develop app-based and chatbot-based disease monitoring and interventions in COPD. Trial Registration ClinicalTrials.gov identifier: NCT04373070; https://clinicaltrials.gov/ct2/show/NCT04373070 International Registered Report Identifier (IRRID) DERR1-10.2196/20412

scholarly journals Maintaining quality of life in patients with chronic obstructive pulmonary disease (COPD) by extending the maintenance phase of community-based pulmonary rehabilitation: protocol for a randomised controlled trial (ComEx3 Study)

2020 ◽  
Vol 7 (1) ◽  
pp. e000548
Author(s):  
Derrick Lopez ◽  
Nola Cecins ◽  
Joanne Cockram ◽  
Anna Collins ◽  
Holly Landers ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Obstructive Pulmonary Disease ◽  
Randomised Controlled Trial ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Randomised Controlled ◽  
Maintenance Programme

IntroductionPulmonary rehabilitation is a core component of the treatment of people with chronic obstructive pulmonary disease (COPD); however, the benefits gained diminish in the ensuing months. The optimal strategy for maintaining the benefits is unclear with weekly supervised maintenance exercise programmes proposed as one strategy. However, the long-term future of maintenance programs is dependent on quality evidence.Methods and analysisThe ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care. 120 participants with COPD will be recruited. Primary objective is to determine health-related quality of life over 12 months. Secondary objectives are to determine functional exercise capacity trajectory and to perform an economic evaluation of the intervention to the health system. Outcomes will be analysed for superiority according to intention-to-treat and per-protocol approaches.Ethics and disseminationApproval has been received from the relevant ethics committees. Findings will be disseminated in peer-reviewed journals and conferences, targeting those involved in managing people with COPD as well as those who develop policies and guidelines.Clinical trial registrationANZCTR 12618000933257

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