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Chronic Obstructive Pulmonary DiseasePhase 4NCT00440687

Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

A Phase 4 study of Chronic Obstructive Pulmonary Disease, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2001to Mar 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Smoker or ex smoker of at least 10 pack years
  • Age 40 or above
  • Prior and current use of inhaled corticosteroids for at least 6 months duration (Used for at least 75% of time on direct questioning)
  • FEV1 <80% of predicted, FEV1/FVC ratio <70%.
  • Less than 15% change and <200 mls change in FEV1 20 minutes after 5 mg nebulised salbutamol.
  • 256 patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year

Who cannot join

  • Clear history of asthma, bronchiectasis, carcinoma of bronchus or other significant respiratory disease
  • Inability to give informed consent (severe mental illness, mental handicap or brain damage).
  • Recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation)
  • Classification as a never smoker
  • Strongly positive skin allergy result (>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry, Barts and The London, 2 Newark Street,.

    London and Essex, London, E1 2AT

Other trials in United Kingdom

About this study

Official title: Phase 4 Withdrawal of Inhaled Corticosteroids in Patients With Chronic Obstructive Pulmonary Disease in Primary Care: a Randomised Controlled Trial

Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown.This randomised double-blind placebo-controlled trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD recruited from general practice. Participants will have a clinical and spirometric diagnosis of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler) or an identical placebo inhaler. Patients will be monitored using diary cards for a year with 3 monthly follow-up visits at their general practice. The primary outcome measures will be exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs, health status, lung function and unscheduled care. We tested the hypothesis that withdrawal of ICS in this population would lead to an increased number of exacerbations, earlier onset of exacerbation, and a worsening of symptoms.

Read the detailed description

To determine whether withdrawal of inhaled corticosteroids in patients with COPD in general practice effects:

  • the frequency of exacerbations compared to a control group
  • differences in health status compared to a control group
  • differences in lung function compared to a control group
  • changes in unscheduled care compared to a control group
  • Direct and indirect costs compared to a control group

Hypothesis

The withdrawal of inhaled corticosteroids from patients with COPD identified in primary care will cause an increase in frequency and severity of exacerbations and is not cost-effective.

Being tested
Fluticasone 500mcg BD via accuhaler or identical placebo
Keywords
chronic obstructive pulmonary disease, primary care, randomised trials, therapeutic interventions
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluticasone 500mcg BD via accuhaler or identical placeboDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the frequency of exacerbations compared to a control group

Secondary outcomes (6)

  1. differences in time to first exacerbation compared to control group

  2. differences in health status compared to a control group

  3. differences in lung function compared to a control group

  4. changes in unscheduled care compared to a control group

  5. direct and indirect costs compared to a control group

  6. comparison of side effects between groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2007 (estimated)
  2. Study startJan 2001
  3. Study completionMar 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
256 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00440687
Sponsor's protocol ID
QMUL - WISP 01
Other IDs
British Lung Foundation P00/8
Status last verified
Feb 2007
First submitted
26 Feb 2007
Last updated
27 Feb 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 May;157(5 Pt 1):1418-22. doi: 10.1164/ajrccm.157.5.9709032.

    PubMed 9603117

  • Miravitlles M, Ferrer M, Pont A, Zalacain R, Alvarez-Sala JL, Masa F, Verea H, Murio C, Ros F, Vidal R; IMPAC Study Group. Effect of exacerbations on quality of life in patients with chronic obstructive pulmonary disease: a 2 year follow up study. Thorax. 2004 May;59(5):387-95. doi: 10.1136/thx.2003.008730.

    PubMed 15115864

  • McGuire A, Irwin DE, Fenn P, Gray A, Anderson P, Lovering A, MacGowan A. The excess cost of acute exacerbations of chronic bronchitis in patients aged 45 and older in England and Wales. Value Health. 2001 Sep-Oct;4(5):370-5. doi: 10.1046/j.1524-4733.2001.45049.x.

    PubMed 11705127

  • Davies L, Angus RM, Calverley PM. Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: a prospective randomised controlled trial. Lancet. 1999 Aug 7;354(9177):456-60. doi: 10.1016/s0140-6736(98)11326-0.

    PubMed 10465169

  • Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52. doi: 10.1136/thorax.57.10.847.

    PubMed 12324669

  • Kanner RE, Anthonisen NR, Connett JE; Lung Health Study Research Group. Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med. 2001 Aug 1;164(3):358-64. doi: 10.1164/ajrccm.164.3.2010017.

    PubMed 11500333

  • Spencer S, Calverley PM, Burge PS, Jones PW. Impact of preventing exacerbations on deterioration of health status in COPD. Eur Respir J. 2004 May;23(5):698-702. doi: 10.1183/09031936.04.00121404.

    PubMed 15176682

  • Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ. 2000 May 13;320(7245):1297-303. doi: 10.1136/bmj.320.7245.1297.

    PubMed 10807619

  • Calverley P, Pauwels R, Vestbo J, Jones P, Pride N, Gulsvik A, Anderson J, Maden C; TRial of Inhaled STeroids ANd long-acting beta2 agonists study group. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2003 Feb 8;361(9356):449-56. doi: 10.1016/S0140-6736(03)12459-2.

    PubMed 12583942

  • Paggiaro PL, Dahle R, Bakran I, Frith L, Hollingworth K, Efthimiou J. Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. Lancet. 1998 Mar 14;351(9105):773-80. doi: 10.1016/s0140-6736(97)03471-5.

    PubMed 9519948

  • 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. doi: 10.1016/s0002-9343(02)01143-9.

    PubMed 12106623

  • National Collaborating Centre for Chronic Conditions. Chronic obstructive pulmonary disease. National clinical guideline on management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax. 2004 Feb;59 Suppl 1(Suppl 1):1-232. No abstract available.

    PubMed 15041752

  • Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001 Apr;163(5):1256-76. doi: 10.1164/ajrccm.163.5.2101039. No abstract available.

    PubMed 11316667

  • Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026.

    PubMed 15672843

  • Tirimanna PR, van Schayck CP, den Otter JJ, van Weel C, van Herwaarden CL, van den Boom G, van Grunsven PM, van den Bosch WJ. Prevalence of asthma and COPD in general practice in 1992: has it changed since 1977? Br J Gen Pract. 1996 May;46(406):277-81.

    PubMed 8762742

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Chronic Obstructive Pulmonary Disease, run by Queen Mary University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the frequency of exacerbations compared to a control group. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00440687, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2007.

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