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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00975195




Registration number
NCT00975195
Ethics application status
Date submitted
10/09/2009
Date registered
11/09/2009
Date last updated
10/02/2015

Titles & IDs
Public title
Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
Scientific title
A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
Secondary ID [1] 0 0
2007-002522-29
Secondary ID [2] 0 0
352.2046
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: fluticasone high dose - fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate

Experimental: fluticasone medium & low doses - fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Moderate or Severe On-treatment COPD Exacerbation
Timepoint [1] 0 0
During randomised treatment, up to 488 days
Secondary outcome [1] 0 0
Number of Moderate or Severe On-treatment COPD Exacerbations
Timepoint [1] 0 0
During randomised treatment, up to 488 days
Secondary outcome [2] 0 0
Proportion of Patients With =1 Moderate or Severe On-treatment COPD Exacerbation
Timepoint [2] 0 0
During randomised treatment, up to 488 days
Secondary outcome [3] 0 0
Time to First Severe On-treatment COPD Exacerbation
Timepoint [3] 0 0
During randomised treatment, up to 488 days
Secondary outcome [4] 0 0
Number of Severe On-treatment COPD Exacerbations
Timepoint [4] 0 0
During randomised treatment, up to 488 days
Secondary outcome [5] 0 0
Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.
Timepoint [5] 0 0
During randomised treatment, up to 488 days
Secondary outcome [6] 0 0
Time to First On-treatment COPD Exacerbation
Timepoint [6] 0 0
During randomised treatment, up to 488 days
Secondary outcome [7] 0 0
Number of On-treatment COPD Exacerbations
Timepoint [7] 0 0
During randomised treatment, up to 488 days
Secondary outcome [8] 0 0
Proportion of Patients With at Least One On-treatment COPD Exacerbation
Timepoint [8] 0 0
During randomised treatment, up to 488 days
Secondary outcome [9] 0 0
Severity of On-treatment COPD Exacerbations
Timepoint [9] 0 0
During randomised treatment, up to 488 days
Secondary outcome [10] 0 0
Change in On-treatment Lung Function as Measured by Trough FEV1
Timepoint [10] 0 0
Baseline and week 6, 12, 18 and 52 visits
Secondary outcome [11] 0 0
Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
Timepoint [11] 0 0
Baseline and week 18 and 52 visits
Secondary outcome [12] 0 0
Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
Timepoint [12] 0 0
Baseline and week 18 and 52 visits
Secondary outcome [13] 0 0
Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
Timepoint [13] 0 0
Baseline and week 18 and 52 visits
Secondary outcome [14] 0 0
Change in On-treatment BODE Index
Timepoint [14] 0 0
Baseline and week 18 and 52 visits
Secondary outcome [15] 0 0
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
Timepoint [15] 0 0
Baseline and week 12, 18 and 52 visits
Secondary outcome [16] 0 0
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
Timepoint [16] 0 0
Baseline and week 12, 18 and 52 visits
Secondary outcome [17] 0 0
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
Timepoint [17] 0 0
Baseline and week 12, 18 and 52 visits
Secondary outcome [18] 0 0
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
Timepoint [18] 0 0
Baseline and week 12, 18 and 52 visits
Secondary outcome [19] 0 0
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Timepoint [19] 0 0
Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Secondary outcome [20] 0 0
Change in On-treatment FVC as Measured by Home Based Spirometry
Timepoint [20] 0 0
Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Secondary outcome [21] 0 0
Change in On-treatment PEFR as Measured by Home Based Spirometry
Timepoint [21] 0 0
Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Secondary outcome [22] 0 0
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
Timepoint [22] 0 0
Baseline and week 27 and 52 visits
Secondary outcome [23] 0 0
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
Timepoint [23] 0 0
Baseline and week 27 and 52 visits
Secondary outcome [24] 0 0
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
Timepoint [24] 0 0
Baseline and week 27 and 52 visits
Secondary outcome [25] 0 0
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
Timepoint [25] 0 0
Baseline and week 27 and 52 visits
Secondary outcome [26] 0 0
Change in On-treatment Physician Global Evaluation
Timepoint [26] 0 0
Baseline and week 27 and 52 visits

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Male or female aged 40 years or more
2. Severe to very severe chronic obstructive pulmonary disease (COPD)
3. Current or ex-smoker with smoking history of at least 10 pack years
4. At least one documented exacerbation of COPD in previous year
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Significant diseases other than COPD; significant alcohol or drug abuse
2. Current clinical diagnosis of asthma requiring steroid treatment
3. History of thoracotomy with pulmonary resection
4. Regular use of daytime oxygen
5. Recent history (within 3 months) of myocardial infarction
6. Recent (within 6 weeks) respiratory infection or COPD exacerbation
7. Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day
8. Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention
9. Recent (within 1 year) hospitalisation for cardiac failure
10. Malignancy requiring chemotherapy or radiotherapy
11. Clinical diagnosis of bronchiectasis
12. Pregnant or nursing women
13. Known hypersensitivity to study drugs
14. Current or recent (within 30 days) participation in another clinical study
15. Current participation in or recent completion (within 4 weeks) of a pulmonary rehabilitation program

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
2488
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
352.2046.61006 Boehringer Ingelheim Investigational Site - Concord
Recruitment hospital [2] 0 0
352.2046.61001 Boehringer Ingelheim Investigational Site - Glebe
Recruitment hospital [3] 0 0
352.2046.61002 Boehringer Ingelheim Investigational Site - Westmead
Recruitment hospital [4] 0 0
352.2046.61004 Boehringer Ingelheim Investigational Site - Daw Park
Recruitment hospital [5] 0 0
352.2046.61003 Boehringer Ingelheim Investigational Site - Toorak Gardens
Recruitment hospital [6] 0 0
352.2046.61005 Boehringer Ingelheim Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Glebe
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Daw Park
Recruitment postcode(s) [5] 0 0
- Toorak Gardens
Recruitment postcode(s) [6] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Eupen
Country [3] 0 0
Belgium
State/province [3] 0 0
Gilly
Country [4] 0 0
Belgium
State/province [4] 0 0
Herentals
Country [5] 0 0
Belgium
State/province [5] 0 0
Jambes
Country [6] 0 0
Belgium
State/province [6] 0 0
Lebbeke
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Middelheim
Country [9] 0 0
Belgium
State/province [9] 0 0
Montigny-le-Tilleul
Country [10] 0 0
Belgium
State/province [10] 0 0
Turnhout
Country [11] 0 0
Brazil
State/province [11] 0 0
Goiania
Country [12] 0 0
Brazil
State/province [12] 0 0
Goiânia
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Brazil
State/province [13] 0 0
Porto Alegre
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Bulgaria
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Bourgas
Country [16] 0 0
Bulgaria
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Rousse
Country [17] 0 0
Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
Country [19] 0 0
Bulgaria
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Veliko Tarnovo
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Chongqing
Country [22] 0 0
China
State/province [22] 0 0
Guangzhou
Country [23] 0 0
China
State/province [23] 0 0
Shanghai
Country [24] 0 0
China
State/province [24] 0 0
Wuhan
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Denmark
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Aarhus C
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Denmark
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København NV
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Odense C
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France
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Brest
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Castelnau le Lez
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Clermont Ferrand cedex 1
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Forbach
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France
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Marseille cedex 20
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Marseille
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Montpellier
Country [35] 0 0
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Nantes Cedex 1
Country [36] 0 0
France
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Nantes
Country [37] 0 0
France
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Nîmes
Country [38] 0 0
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Perpignan
Country [39] 0 0
France
State/province [39] 0 0
Saint Laurent du Var
Country [40] 0 0
France
State/province [40] 0 0
Saint-Pierre cedex
Country [41] 0 0
France
State/province [41] 0 0
Toulouse cedex 9
Country [42] 0 0
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Toulouse
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Bochum
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Cottbus
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Germany
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Frankfurt
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Geesthacht
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Gelnhausen
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Kharkiv
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Vinnitsa
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Vinnytsya
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United Kingdom
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Baillieston, Glasgow
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Barnsley
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Belfast
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Birmingham
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Cambridge
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Chertsey
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Chesterfield
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Cottingham, Hull
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Inverness
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Isleworth
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Liverpool
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Norwich
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Windsor

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.
Trial website
https://clinicaltrials.gov/study/NCT00975195
Trial related presentations / publications
Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018-0944-3.
Watz H, Tetzlaff K, Wouters EF, Kirsten A, Magnussen H, Rodriguez-Roisin R, Vogelmeier C, Fabbri LM, Chanez P, Dahl R, Disse B, Finnigan H, Calverley PM. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med. 2016 May;4(5):390-8. doi: 10.1016/S2213-2600(16)00100-4. Epub 2016 Apr 7.
Magnussen H, Disse B, Rodriguez-Roisin R, Kirsten A, Watz H, Tetzlaff K, Towse L, Finnigan H, Dahl R, Decramer M, Chanez P, Wouters EF, Calverley PM; WISDOM Investigators. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014 Oct 2;371(14):1285-94. doi: 10.1056/NEJMoa1407154. Epub 2014 Sep 8.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00975195