Pulmonary Disease, Chronic ObstructivePhase 4NCT00975195

Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

A Phase 4 study testing tiotropium inhalation, salmeterol xinafoate and fluticasone propionate in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 222 sites in 23 countries.

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

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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: tiotropium inhalation, salmeterol xinafoate and fluticasone propionate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,488 participants
Where: 222 sitesin 23 countries
Study dates: Feb 2009to Jul 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male or female aged 40 years or more
Severe to very severe chronic obstructive pulmonary disease (COPD)
Current or ex-smoker with smoking history of at least 10 pack years
At least one documented exacerbation of COPD in previous year

Who cannot join

Significant diseases other than COPD; significant alcohol or drug abuse
Current clinical diagnosis of asthma requiring steroid treatment
History of thoracotomy with pulmonary resection
Regular use of daytime oxygen
Recent history (within 3 months) of myocardial infarction
Recent (within 6 weeks) respiratory infection or COPD exacerbation

Show all 15Show fewer

Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day
Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention
Recent (within 1 year) hospitalisation for cardiac failure
Malignancy requiring chemotherapy or radiotherapy
Clinical diagnosis of bronchiectasis
Pregnant or nursing women
Known hypersensitivity to study drugs
Current or recent (within 30 days) participation in another clinical study
Current participation in or recent completion (within 4 weeks) of a pulmonary rehabilitation program

Trial locations and contacts

222 sites in 23 countries.

Country

City, postcode or hospital

222 sites in 23 countries

France33 sites

352.2046.3317A Boehringer Ingelheim Investigational Site
Brest
352.2046.3317B Boehringer Ingelheim Investigational Site
Brest
352.2046.3317C Boehringer Ingelheim Investigational Site
Brest
352.2046.3320A Boehringer Ingelheim Investigational Site
Castelnau-le-Lez
352.2046.3320B Boehringer Ingelheim Investigational Site
Castelnau-le-Lez
352.2046.3320C Boehringer Ingelheim Investigational Site
Castelnau-le-Lez
352.2046.3335A Boehringer Ingelheim Investigational Site
Clermont-Ferrand
352.2046.3314A Boehringer Ingelheim Investigational Site
Forbach
352.2046.3301A Boehringer Ingelheim Investigational Site
Marseille
352.2046.3333A Boehringer Ingelheim Investigational Site
Marseille
352.2046.3326A Boehringer Ingelheim Investigational Site
Montpellier
352.2046.3326C Boehringer Ingelheim Investigational Site
Montpellier
352.2046.3325A Boehringer Ingelheim Investigational Site
Nantes
352.2046.3325C Boehringer Ingelheim Investigational Site
Nantes
352.2046.3325D Boehringer Ingelheim Investigational Site
Nantes
352.2046.3334A Boehringer Ingelheim Investigational Site
Nantes
352.2046.3324A Boehringer Ingelheim Investigational Site
Nîmes
352.2046.3332A Boehringer Ingelheim Investigational Site
Nîmes
352.2046.3332B Boehringer Ingelheim Investigational Site
Nîmes
352.2046.3332C Boehringer Ingelheim Investigational Site
Nîmes
352.2046.3331A Boehringer Ingelheim Investigational Site
Perpignan
352.2046.3331B Boehringer Ingelheim Investigational Site
Perpignan
352.2046.3331C Boehringer Ingelheim Investigational Site
Perpignan
352.2046.3329A Boehringer Ingelheim Investigational Site
Saint-Laurent-du-Var
352.2046.3329B Boehringer Ingelheim Investigational Site
Saint-Laurent-du-Var
352.2046.3302A Boehringer Ingelheim Investigational Site
Saint-Pierre
352.2046.3302B Boehringer Ingelheim Investigational Site
Saint-Pierre
352.2046.3302C Boehringer Ingelheim Investigational Site
Saint-Pierre
352.2046.3302D Boehringer Ingelheim Investigational Site
Saint-Pierre
352.2046.3336A Boehringer Ingelheim Investigational Site
Toulouse
352.2046.3336B Boehringer Ingelheim Investigational Site
Toulouse
352.2046.3336C Boehringer Ingelheim Investigational Site
Toulouse
352.2046.3337A Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

Germany19 sites

352.2046.49012 Boehringer Ingelheim Investigational Site
Berlin
352.2046.49020 Boehringer Ingelheim Investigational Site
Berlin
352.2046.49021 Boehringer Ingelheim Investigational Site
Berlin
352.2046.49008 Boehringer Ingelheim Investigational Site
Bochum
352.2046.49003 Boehringer Ingelheim Investigational Site
Cologne
352.2046.49019 Boehringer Ingelheim Investigational Site
Cottbus
352.2046.49002 Boehringer Ingelheim Investigational Site
Donaustauf
352.2046.49013 Boehringer Ingelheim Investigational Site
Frankfurt
352.2046.49025 Boehringer Ingelheim Investigational Site
Frankfurt
352.2046.49023 Boehringer Ingelheim Investigational Site
Frankfurt am Main
352.2046.49024 Boehringer Ingelheim Investigational Site
Geesthacht
352.2046.49022 Boehringer Ingelheim Investigational Site
Gelnhausen
352.2046.49001 Boehringer Ingelheim Investigational Site
Großhansdorf
352.2046.49006 Boehringer Ingelheim Investigational Site
Heidelberg
352.2046.49014 Boehringer Ingelheim Investigational Site
Immenhausen
352.2046.49016 Boehringer Ingelheim Investigational Site
Kiel
352.2046.49004 Boehringer Ingelheim Investigational Site
Mainz
352.2046.49005 Boehringer Ingelheim Investigational Site
Marburg
352.2046.49015 Boehringer Ingelheim Investigational Site
München

Other trials in Germany

Turkey (Türkiye)17 sites

352.2046.90009 Boehringer Ingelheim Investigational Site
Ankara
352.2046.90019 Boehringer Ingelheim Investigational Site
Ankara
352.2046.90016 Boehringer Ingelheim Investigational Site
Bursa
352.2046.90010 Boehringer Ingelheim Investigational Site
Denizli
352.2046.90003 Boehringer Ingelheim Investigational Site
Istanbul
352.2046.90004 Boehringer Ingelheim Investigational Site
Istanbul
352.2046.90006 Boehringer Ingelheim Investigational Site
Istanbul
352.2046.90008 Boehringer Ingelheim Investigational Site
Istanbul
352.2046.90012 Boehringer Ingelheim Investigational Site
Istanbul
352.2046.90017 Boehringer Ingelheim Investigational Site
Istanbul
352.2046.90011 Boehringer Ingelheim Investigational Site
Izmir
352.2046.90014 Boehringer Ingelheim Investigational Site
Izmir
352.2046.90018 Boehringer Ingelheim Investigational Site
Izmir
352.2046.90005 Boehringer Ingelheim Investigational Site
İzmit
352.2046.90007 Boehringer Ingelheim Investigational Site
Kayseri
352.2046.90001 Boehringer Ingelheim Investigational Site
Mersin
352.2046.90002 Boehringer Ingelheim Investigational Site
Samsun

Other trials in Turkey (Türkiye)

United Kingdom16 sites

352.2046.44008 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow
352.2046.44009 Boehringer Ingelheim Investigational Site
Barnsley
352.2046.44018 Boehringer Ingelheim Investigational Site
Belfast
352.2046.44010 Boehringer Ingelheim Investigational Site
Birmingham
352.2046.44003 Boehringer Ingelheim Investigational Site
Cambridge
352.2046.44026 Boehringer Ingelheim Investigational Site
Chertsey
352.2046.44006 Boehringer Ingelheim Investigational Site
Chesterfield
352.2046.44012 Boehringer Ingelheim Investigational Site
Cottingham, Hull
352.2046.44028 Boehringer Ingelheim Investigational Site
Inverness
352.2046.44016 Boehringer Ingelheim Investigational Site
Isleworth
352.2046.44002 Boehringer Ingelheim Investigational Site
Liverpool
352.2046.44001 Boehringer Ingelheim Investigational Site
London
352.2046.44017 Boehringer Ingelheim Investigational Site
Norwich
352.2046.44021 Boehringer Ingelheim Investigational Site
Sheffield
352.2046.44019 Boehringer Ingelheim Investigational Site
Sunderland
352.2046.44025 Boehringer Ingelheim Investigational Site
Windsor

Other trials in United Kingdom

Belgium11 sites

352.2046.32002 Boehringer Ingelheim Investigational Site
Brussels
352.2046.32016 Boehringer Ingelheim Investigational Site
Brussels
352.2046.32015 Boehringer Ingelheim Investigational Site
Eupen
352.2046.32017 Boehringer Ingelheim Investigational Site
Gilly
352.2046.32014 Boehringer Ingelheim Investigational Site
Herentals
352.2046.32006 Boehringer Ingelheim Investigational Site
Jambes
352.2046.32008 Boehringer Ingelheim Investigational Site
Lebbeke
352.2046.32001 Boehringer Ingelheim Investigational Site
Leuven
352.2046.32004 Boehringer Ingelheim Investigational Site
Middelheim
352.2046.32010 Boehringer Ingelheim Investigational Site
Montigny-le-Tilleul
352.2046.32013 Boehringer Ingelheim Investigational Site
Turnhout

Other trials in Belgium

Greece11 sites

352.2046.30003 Boehringer Ingelheim Investigational Site
Athens
352.2046.30004 Boehringer Ingelheim Investigational Site
Athens
352.2046.30005 Boehringer Ingelheim Investigational Site
Athens
352.2046.30007 Boehringer Ingelheim Investigational Site
Athens
352.2046.30008 Boehringer Ingelheim Investigational Site
Athens
352.2046.30011 Boehringer Ingelheim Investigational Site
Athens
352.2046.30012 Boehringer Ingelheim Investigational Site
Athens
352.2046.30006 Boehringer Ingelheim Investigational Site
Heraklion
352.2046.30009 Boehringer Ingelheim Investigational Site
Larissa
352.2046.30001 Boehringer Ingelheim Investigational Site
Thessaloniki
352.2046.30002 Boehringer Ingelheim Investigational Site
Thessaloniki

Other trials in Greece

Russia9 sites

352.2046.07006 Boehringer Ingelheim Investigational Site
Ivanovo
352.2046.07008 Boehringer Ingelheim Investigational Site
Moscow
352.2046.07009 Boehringer Ingelheim Investigational Site
Moscow
352.2046.07001 Boehringer Ingelheim Investigational Site
Saint Petersburg
352.2046.07002 Boehringer Ingelheim Investigational Site
Samara
352.2046.07003 Boehringer Ingelheim Investigational Site
Saratov
352.2046.07004 Boehringer Ingelheim Investigational Site
Yaroslavl
352.2046.07005 Boehringer Ingelheim Investigational Site
Yaroslavl
352.2046.07011 Boehringer Ingelheim Investigational Site
Yekaterinburg

Other trials in Russia

Spain9 sites

352.2046.34008 Boehringer Ingelheim Investigational Site
Badajoz
352.2046.34002 Boehringer Ingelheim Investigational Site
Barakaldo (Bilbao)
352.2046.34001 Boehringer Ingelheim Investigational Site
Barcelona
352.2046.34004 Boehringer Ingelheim Investigational Site
Barcelona
352.2046.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
352.2046.34006 Boehringer Ingelheim Investigational Site
Palma de Mallorca
352.2046.34010 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón
352.2046.34013 Boehringer Ingelheim Investigational Site
Salt (Girona)
352.2046.34011 Boehringer Ingelheim Investigational Site
Seville

Other trials in Spain

Bulgaria8 sites

352.2046.35905 Boehringer Ingelheim Investigational Site
Burgas
352.2046.35902 Boehringer Ingelheim Investigational Site
Rousse
352.2046.35904 Boehringer Ingelheim Investigational Site
Sofia
352.2046.35906 Boehringer Ingelheim Investigational Site
Sofia
352.2046.35907 Boehringer Ingelheim Investigational Site
Sofia
352.2046.35908 Boehringer Ingelheim Investigational Site
Sofia
352.2046.35903 Boehringer Ingelheim Investigational Site
Stara Zagora
352.2046.35909 Boehringer Ingelheim Investigational Site
Veliko Tarnovo

Other trials in Bulgaria

China8 sites

352.2046.86002 Boehringer Ingelheim Investigational Site
Beijing
352.2046.86003 Boehringer Ingelheim Investigational Site
Beijing
352.2046.86006 Boehringer Ingelheim Investigational Site
Beijing
352.2046.86008 Boehringer Ingelheim Investigational Site
Chongqing
352.2046.86001 Boehringer Ingelheim Investigational Site
Guangzhou
352.2046.86004 Boehringer Ingelheim Investigational Site
Shanghai
352.2046.86005 Boehringer Ingelheim Investigational Site
Shanghai
352.2046.86007 Boehringer Ingelheim Investigational Site
Wuhan

Other trials in China

Italy8 sites

352.2046.39002 Boehringer Ingelheim Investigational Site
Catania
352.2046.39007 Boehringer Ingelheim Investigational Site
Cona
352.2046.39005 Boehringer Ingelheim Investigational Site
Foggia
352.2046.39003 Boehringer Ingelheim Investigational Site
Modena
352.2046.39006 Boehringer Ingelheim Investigational Site
Montescano (pv)
352.2046.39001 Boehringer Ingelheim Investigational Site
Pisa
352.2046.39004 Boehringer Ingelheim Investigational Site
Sesto S. Giovanni (mi)
352.2046.39008 Boehringer Ingelheim Investigational Site
Tradate (va)

Other trials in Italy

Philippines8 sites

352.2046.63001 Boehringer Ingelheim Investigational Site
Caloocan
352.2046.63009 Boehringer Ingelheim Investigational Site
City of Muntinlupa
352.2046.63003 Boehringer Ingelheim Investigational Site
Manila
352.2046.63004 Boehringer Ingelheim Investigational Site
Manila
352.2046.63005 Boehringer Ingelheim Investigational Site
Quezon
352.2046.63007 Boehringer Ingelheim Investigational Site
Quezon
352.2046.63006 Boehringer Ingelheim Investigational Site
Quezon City
352.2046.63008 Boehringer Ingelheim Investigational Site
Quezon City

Other trials in Philippines

Poland8 sites

352.2046.48006 Boehringer Ingelheim Investigational Site
Bytom
352.2046.48003 Boehringer Ingelheim Investigational Site
Ostrow Wielkopolska
352.2046.48001 Boehringer Ingelheim Investigational Site
Poznan
352.2046.48002 Boehringer Ingelheim Investigational Site
Poznan
352.2046.48009 Boehringer Ingelheim Investigational Site
Rzeszów
352.2046.48011 Boehringer Ingelheim Investigational Site
Tarnowskie Góry
352.2046.48005 Boehringer Ingelheim Investigational Site
Warsaw
352.2046.48007 Boehringer Ingelheim Investigational Site
Wroclaw

Other trials in Poland

Hungary7 sites

352.2046.36003 Boehringer Ingelheim Investigational Site
Cegléd
352.2046.36002 Boehringer Ingelheim Investigational Site
Deszk
352.2046.36004 Boehringer Ingelheim Investigational Site
Komárom
352.2046.36006 Boehringer Ingelheim Investigational Site
Pécs
352.2046.36001 Boehringer Ingelheim Investigational Site
Szarvas
352.2046.36005 Boehringer Ingelheim Investigational Site
Százhalombatta
352.2046.36011 Boehringer Ingelheim Investigational Site
Szigetszentmiklós

Other trials in Hungary

New Zealand7 sites

352.2046.64007 Boehringer Ingelheim Investigational Site
Auckland NZ
352.2046.64003 Boehringer Ingelheim Investigational Site
Christchurch
352.2046.64004 Boehringer Ingelheim Investigational Site
Dunedin
352.2046.64006 Boehringer Ingelheim Investigational Site
Hamilton
352.2046.64001 Boehringer Ingelheim Investigational Site
Newtown Wellington NZ
352.2046.64005 Boehringer Ingelheim Investigational Site
Otahuhu New Zealand
352.2046.64002 Boehringer Ingelheim Investigational Site
Tauranga

Other trials in New Zealand

South Africa7 sites

352.2046.27002 Boehringer Ingelheim Investigational Site
Bellville
352.2046.27001 Boehringer Ingelheim Investigational Site
Cape Town
352.2046.27003 Boehringer Ingelheim Investigational Site
Cape Town
352.2046.27006 Boehringer Ingelheim Investigational Site
eManzimtoti
352.2046.27007 Boehringer Ingelheim Investigational Site
Pretoria
352.2046.27005 Boehringer Ingelheim Investigational Site
Somerset West
352.2046.27004 Boehringer Ingelheim Investigational Site
Tygerberg

Other trials in South Africa

Ukraine7 sites

352.2046.38007 Boehringer Ingelheim Investigational Site
Ivano-Frankivsk
352.2046.38002 Boehringer Ingelheim Investigational Site
Kharkiv
352.2046.38003 Boehringer Ingelheim Investigational Site
Kharkiv
352.2046.38004 Boehringer Ingelheim Investigational Site
Kiev
352.2046.38006 Boehringer Ingelheim Investigational Site
Kiev
352.2046.38005 Boehringer Ingelheim Investigational Site
Vinnitsa
352.2046.38001 Boehringer Ingelheim Investigational Site
Vinnytsia

Other trials in Ukraine

Australia6 sites

352.2046.61006 Boehringer Ingelheim Investigational Site
Concord, New South Wales
352.2046.61004 Boehringer Ingelheim Investigational Site
Daw Park, South Australia
352.2046.61001 Boehringer Ingelheim Investigational Site
Glebe, New South Wales
352.2046.61003 Boehringer Ingelheim Investigational Site
Toorak Gardens, South Australia
352.2046.61002 Boehringer Ingelheim Investigational Site
Westmead, New South Wales
352.2046.61005 Boehringer Ingelheim Investigational Site
Woodville, South Australia

Other trials in Australia

Taiwan6 sites

352.2046.88607 Boehringer Ingelheim Investigational Site
Dawan
352.2046.88608 Boehringer Ingelheim Investigational Site
Dawan
352.2046.88606 Boehringer Ingelheim Investigational Site
Kaohsiung City
352.2046.88604 Boehringer Ingelheim Investigational Site
Taichung
352.2046.88601 Boehringer Ingelheim Investigational Site
Taipei
352.2046.88603 Boehringer Ingelheim Investigational Site
Taipei

Other trials in Taiwan

Brazil5 sites

352.2046.55002 Boehringer Ingelheim Investigational Site
Goiânia
352.2046.55005 Boehringer Ingelheim Investigational Site
Goiânia
352.2046.55001 Boehringer Ingelheim Investigational Site
Porto Alegre
352.2046.55006 Boehringer Ingelheim Investigational Site
Porto Alegre
352.2046.55003 Boehringer Ingelheim Investigational Site
São Paulo

Other trials in Brazil

Tunisia5 sites

352.2046.2161A Boehringer Ingelheim Investigational Site
Aryanah
352.2046.2162A Boehringer Ingelheim Investigational Site
Aryanah
352.2046.2165A Boehringer Ingelheim Investigational Site
Sfax
352.2046.2164A Boehringer Ingelheim Investigational Site
Sousse
352.2046.2163A Boehringer Ingelheim Investigational Site
Tunis

Other trials in Tunisia

Netherlands4 sites

352.2046.31004 Boehringer Ingelheim Investigational Site
Heerlen
352.2046.31001 Boehringer Ingelheim Investigational Site
Leeuwarden
352.2046.31003 Boehringer Ingelheim Investigational Site
Rotterdam
352.2046.31002 Boehringer Ingelheim Investigational Site
Veldhoven

Other trials in Netherlands

Denmark3 sites

352.2046.45001 Boehringer Ingelheim Investigational Site
Aarhus C
352.2046.45003 Boehringer Ingelheim Investigational Site
København NV
352.2046.45002 Boehringer Ingelheim Investigational Site
Odense C

Other trials in Denmark

About this study

Official 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

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: tiotropium inhalation, salmeterol xinafoate, fluticasone propionate, placebo matched for fluticasone propionate
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.

tiotropium inhalationDrug
salmeterol xinafoateDrug
fluticasone propionateDrug
placebo matched for fluticasone propionateDrug

Study groups in NCT00975195
Study group	Role	What they receive
fluticasone high dose	Experimental	fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate Receives: Drug: tiotropium inhalation; Drug: salmeterol xinafoate; Drug: fluticasone propionate
fluticasone medium & low doses	Experimental	fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate Receives: Drug: tiotropium inhalation; Drug: salmeterol xinafoate; Drug: fluticasone propionate; Drug: placebo matched for fluticasone propionate

What is being measured

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

Time to First Moderate or Severe On-treatment COPD Exacerbation
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.
Measured: During randomised treatment, up to 488 days

Secondary outcomes (26)

Number of Moderate or Severe On-treatment COPD Exacerbations
Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.
Measured values show adjusted mean event rate.
Measured: During randomised treatment, up to 488 days
Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation
Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.
Measured: During randomised treatment, up to 488 days
Time to First Severe On-treatment COPD Exacerbation
Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
The "measure type" displays the 25th percentile and its 95% confidence interval.
Measured: During randomised treatment, up to 488 days
Number of Severe On-treatment COPD Exacerbations
Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
Measured values show adjusted event rate.
Measured: During randomised treatment, up to 488 days
Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.
Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
Measured: During randomised treatment, up to 488 days
Time to First On-treatment COPD Exacerbation
Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval.
Measured: During randomised treatment, up to 488 days
Number of On-treatment COPD Exacerbations
Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.
Measured values show adjusted event rate.
Measured: During randomised treatment, up to 488 days
Proportion of Patients With at Least One On-treatment COPD Exacerbation
Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.
Measured: During randomised treatment, up to 488 days
Severity of On-treatment COPD Exacerbations
Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)
Measured: During randomised treatment, up to 488 days
Change in On-treatment Lung Function as Measured by Trough FEV1
Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 6, 12, 18 and 52 visits
Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.
Scale from 0 to 4:
- 0 = not troubled by breathlessness, except during strenuous exercise
- 1 = short of breath when hurrying or walking up a slight hill
- 2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace
- 3 = stops for breath after approximately 100 yards, or after a few minutes on the level
- 4 = too breathless to leave the house, or breathless when dressing or undressing
"No breathlessness" was given a score of -1
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 18 and 52 visits
Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 18 and 52 visits
Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 18 and 52 visits
Change in On-treatment BODE Index
Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 12, 18 and 52 visits
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment FVC as Measured by Home Based Spirometry
Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment PEFR as Measured by Home Based Spirometry
Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 27 and 52 visits
Change in On-treatment Physician Global Evaluation
Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Measured: Baseline and week 27 and 52 visits

Timeline

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

Feb 2009Jul 2013

First posted11 Sep 2009 (estimated)
Study startFeb 2009
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Who is masked: Participant, Investigator
Enrolment: 2,488 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00975195
Sponsor's protocol ID: 352.2046
Other IDs: 2007-002522-29
Status last verified: Feb 2015
First submitted: 10 Sep 2009
Last updated: 10 Feb 2015
Results posted: Yes, on ClinicalTrials.gov

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.
PubMed 32943047
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.
PubMed 30545350
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.
PubMed 27066739
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.
PubMed 25196117

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT00975195
Acronym / sponsor ID: 352.2046
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,488 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 11 Sep 2009 (estimated)
Results: Posted 10 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
fluticasone high dose	Experimental	Drug: tiotropium inhalation, Drug: salmeterol xinafoate, Drug: fluticasone propionatefluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
fluticasone medium & low doses	Experimental	Drug: tiotropium inhalation, Drug: salmeterol xinafoate, Drug: fluticasone propionate, Drug: placebo matched for fluticasone propionatefluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female aged 40 years or more
Severe to very severe chronic obstructive pulmonary disease (COPD)
Current or ex-smoker with smoking history of at least 10 pack years
At least one documented exacerbation of COPD in previous year

Key exclusion criteria (15 listed)

Significant diseases other than COPD; significant alcohol or drug abuse
Current clinical diagnosis of asthma requiring steroid treatment
History of thoracotomy with pulmonary resection
Regular use of daytime oxygen
Recent history (within 3 months) of myocardial infarction

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tiotropium inhalation	Drug	fluticasone high dose, fluticasone medium & low doses
salmeterol xinafoate	Drug	fluticasone high dose, fluticasone medium & low doses
fluticasone propionate	Drug	fluticasone high dose, fluticasone medium & low doses
placebo matched for fluticasone propionate	Drug	fluticasone medium & low doses

Primary outcome

Time to First Moderate or Severe On-treatment COPD Exacerbation
Time frame: During randomised treatment, up to 488 days
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.

26 secondary outcomes

Number of Moderate or Severe On-treatment COPD Exacerbations
Time frame: During randomised treatment, up to 488 days
Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation
Time frame: During randomised treatment, up to 488 days
Time to First Severe On-treatment COPD Exacerbation
Time frame: During randomised treatment, up to 488 days
Number of Severe On-treatment COPD Exacerbations
Time frame: During randomised treatment, up to 488 days
Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.
Time frame: During randomised treatment, up to 488 days
Time to First On-treatment COPD Exacerbation
Time frame: During randomised treatment, up to 488 days
Number of On-treatment COPD Exacerbations
Time frame: During randomised treatment, up to 488 days
Proportion of Patients With at Least One On-treatment COPD Exacerbation
Time frame: During randomised treatment, up to 488 days
Severity of On-treatment COPD Exacerbations
Time frame: During randomised treatment, up to 488 days
Change in On-treatment Lung Function as Measured by Trough FEV1
Time frame: Baseline and week 6, 12, 18 and 52 visits
Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
Time frame: Baseline and week 18 and 52 visits
Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
Time frame: Baseline and week 18 and 52 visits
Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
Time frame: Baseline and week 18 and 52 visits
Change in On-treatment BODE Index
Time frame: Baseline and week 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
Time frame: Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
Time frame: Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
Time frame: Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
Time frame: Baseline and week 12, 18 and 52 visits
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Time frame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment FVC as Measured by Home Based Spirometry
Time frame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment PEFR as Measured by Home Based Spirometry
Time frame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
Time frame: Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
Time frame: Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
Time frame: Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
Time frame: Baseline and week 27 and 52 visits
Change in On-treatment Physician Global Evaluation
Time frame: Baseline and week 27 and 52 visits

Results and safety

Results posted to the registry on 10 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluticasone Maintenance	1,244	1,016
Fluticasone Withdrawal	1,244	1,011

Primary outcome: Time to First Moderate or Severe On-treatment COPD Exacerbation

Time frame: During randomised treatment, up to 488 days. Number (95% Confidence Interval). Unit: days

Measure	Fluticasone Maintenance n = 1243	Fluticasone Withdrawal n = 1242
Value	107.0 (94.0 to 124.0)	110.0 (99.0 to 120.0)

Fluticasone Maintenance vs Fluticasone Withdrawal: Hazard Ratio (HR): 1.058 (95% CI 0.941 to 1.189), p = 0.3497, Chi-squared

Population analysed: Treated set

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluticasone Maintenance	292 of 1,243 (23.5%)	464 of 1,243 (37.3%)	Not reported
Fluticasone Withdrawal	300 of 1,242 (24.2%)	458 of 1,242 (36.9%)	Not reported

Limitations and caveats (from the sponsor): Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32943047Singh 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.
Derived from this study: PubMed 30545350Watz 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.
Derived from this study: PubMed 27066739Watz 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.
Derived from this study: PubMed 25196117Magnussen 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

222 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 15 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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 sites in France, Germany, Turkey (Türkiye), United Kingdom, Belgium and 18 more countries. 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?

Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to First Moderate or Severe On-treatment COPD Exacerbation (time frame: During randomised treatment, up to 488 days). 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 NCT00975195, which also lists 4 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 10 Feb 2015.