Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effect of High Dose Inhaled Budesonide and Fluticasone on Adrenal Function in Patients With Moderate to Severe COPD
National Institute for Clinical Excellence (NICE) guidelines recommend high dose inhaled steroids for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD, a common chronic disease related to smoking) who are having two or more exacerbations requiring treatment with antibiotics or oral steroids in a 12 month period. The preparations licensed for this indication commercially available are Symbicort® and Seretide®. High dose inhaled steroids (contained in both) can cause suppression of the adrenal glands. The investigators want to assess adrenal suppression caused by the two preparations and compare. The results could guide investigators in prescribing these preparations.
Background COPD is a very common disease which is chronic and progressive. Current NICE
guidelines recommend the use of inhaled steroid in relatively high dose in patients with
moderate to severe disease who are having two or more exacerbations requiring treatment with
antibiotics or oral steroids in a 12 month period.The aim of this treatment is to reduce the
exacerbation rates and slow decline in health status. None of the inhaled steroids currently
available are licensed for use alone in the treatment of COPD. They are prescribed in
combination with a long acting beta 2 agonist (LABA, a medication which leads to dilatation
of the airways), which is an effective combination. The combination of a LABA with inhaled
steroid preparations available includes Symbicort® (containing budesonide and formoterol
fumarate and Seretide® (containing fluticasone propionate and salmeterol xinafoate).
Symbicort® has been evaluated in randomized controlled in patients with COPD and has been
found to be beneficial compared to either component alone. Similar data is available for
Seretide® as well. There are no large trials directly comparing the two different
preparations and quite often the choice between the two is made rather empirically. Although
inhaled steroids have a very good safety profile at low doses, the dose used in both these
preparations for use in COPD is high and has got potential for adverse effects such as
adrenal (a gland in the body which secretes steroids) suppression. Studies have shown that
marked adrenal suppression occurs with high dose inhaled steroids.However the doses used in
various studies have been different and these studies have been in the asthmatic group of
patients, the response of whom may be different from those with COPD. The effect of adrenal
function can be assessed by a simple analysis of an overnight urine sample collection. It is
difficult to decide which of the treatments to choose on initiation of therapy. We wish to
compare the adrenal suppression between the two treatments and determine whether there is any
difference, which could influence decision on treatment in specific patient groups who are
considered more at risk for adverse effects. Study design This study will be conducted at a
single centre. The investigators will be responsible for the study. The study is designed as
an 8 week study in which patients will cross over from one arm of the study group to another.
Patients with COPD who are on current treatment with either Symbicort® or Seretide® on doses
as per NICE guidelines will be included. The treatment doses are Symbicort® (budesonide /
formoterol, 400 micrograms/9 micrograms) one puff bd and Seretide® (fluticasone/salmeterol,
250 micrograms/25 micrograms) two puffs bd. We plan to include 30 patients either on current
treatment with Symbicort® or Seretide®. On visit 1 : Patients would either be on treatment
with high dose Symbicort® OR Seretide® (on treatment for at−least four weeks). The patients
will be re−trained in the correct use of their current inhaler and re−educated has to how
often they should be taking the medication. The patient will be guided to take the treatment
as indicated for 4weeks, at the end of the 4 week treatment they will be asked to collect an
overnight (12 hrs) urine sample (21:00 hrs−09:00hrs). The patient will return to the clinic
for visit 2 where they will return the urine sample and quality of life in the previous 4
weeks will be assessed by means of a modified St Georges Respiratory questionnaire. If the
patient was on treatment with Symbicort® it will be switched over to Seretide® and
vice−versa. The patient will be seen 4 weeks later on visit 3.
A bottle for collecting an overnight ( 12 hours) urine sample will be given to the patient
for urine collection at the end of the 4 week treatment period. On visit 3: the patient will
return the overnight urine sample and The quality of life of the patient in the previous 4
weeks will be assessed using the modified St Georges Respiratory Questionnaire.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|