Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

NCT00975195 | Completed Phase 4 Results

• 2 other identifiers: 352.20462007-002522-29
• Study Type: interventional
• Target: 2,488
• Locations: 22 countries
• Sites: 217

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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.

  During randomised treatment, up to 488 days

Secondary Outcomes (26)

• Number of Moderate or Severe On-treatment COPD Exacerbations

  During randomised treatment, up to 488 days

• Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation

  During randomised treatment, up to 488 days

• Time to First Severe On-treatment COPD Exacerbation

  During randomised treatment, up to 488 days

• Number of Severe On-treatment COPD Exacerbations

  During randomised treatment, up to 488 days

• Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.

  During randomised treatment, up to 488 days

Study Arms (2)

fluticasone high dose

EXPERIMENTAL

fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate

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

Drug: tiotropium inhalation; Drug: salmeterol xinafoate; Drug: fluticasone propionate; Drug: placebo matched for fluticasone propionate

Interventions

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (222)

352.2046.61006 Boehringer Ingelheim Investigational Site

Concord, New South Wales, Australia

Location

352.2046.61001 Boehringer Ingelheim Investigational Site

Glebe, New South Wales, Australia

Location

352.2046.61002 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Location

352.2046.61004 Boehringer Ingelheim Investigational Site

Daw Park, South Australia, Australia

Location

352.2046.61003 Boehringer Ingelheim Investigational Site

Toorak Gardens, South Australia, Australia

Location

352.2046.61005 Boehringer Ingelheim Investigational Site

Woodville, South Australia, Australia

Location

352.2046.32002 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

352.2046.32016 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

352.2046.32015 Boehringer Ingelheim Investigational Site

Eupen, Belgium

Location

352.2046.32017 Boehringer Ingelheim Investigational Site

Gilly, Belgium

Location

352.2046.32014 Boehringer Ingelheim Investigational Site

Herentals, Belgium

Location

352.2046.32006 Boehringer Ingelheim Investigational Site

Jambes, Belgium

Location

352.2046.32008 Boehringer Ingelheim Investigational Site

Lebbeke, Belgium

Location

352.2046.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

352.2046.32004 Boehringer Ingelheim Investigational Site

Middelheim, Belgium

Location

352.2046.32010 Boehringer Ingelheim Investigational Site

Montigny-le-Tilleul, Belgium

Location

352.2046.32013 Boehringer Ingelheim Investigational Site

Turnhout, Belgium

Location

352.2046.55002 Boehringer Ingelheim Investigational Site

Goiânia, Brazil

Location

352.2046.55005 Boehringer Ingelheim Investigational Site

Goiânia, Brazil

Location

352.2046.55001 Boehringer Ingelheim Investigational Site

Porto Alegre, Brazil

Location

352.2046.55006 Boehringer Ingelheim Investigational Site

Porto Alegre, Brazil

Location

352.2046.55003 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

352.2046.35905 Boehringer Ingelheim Investigational Site

Burgas, Bulgaria

Location

352.2046.35902 Boehringer Ingelheim Investigational Site

Rousse, Bulgaria

Location

352.2046.35904 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

352.2046.35906 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

352.2046.35907 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

352.2046.35908 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

352.2046.35903 Boehringer Ingelheim Investigational Site

Stara Zagora, Bulgaria

Location

352.2046.35909 Boehringer Ingelheim Investigational Site

Veliko Tarnovo, Bulgaria

Location

352.2046.86002 Boehringer Ingelheim Investigational Site

Beijing, China

Location

352.2046.86003 Boehringer Ingelheim Investigational Site

Beijing, China

Location

352.2046.86006 Boehringer Ingelheim Investigational Site

Beijing, China

Location

352.2046.86008 Boehringer Ingelheim Investigational Site

Chongqing, China

Location

352.2046.86001 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

352.2046.86004 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

352.2046.86005 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

352.2046.86007 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

352.2046.45001 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

352.2046.45003 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

352.2046.45002 Boehringer Ingelheim Investigational Site

Odense C, Denmark

Location

352.2046.3317A Boehringer Ingelheim Investigational Site

Brest, France

Location

352.2046.3317B Boehringer Ingelheim Investigational Site

Brest, France

Location

352.2046.3317C Boehringer Ingelheim Investigational Site

Brest, France

Location

352.2046.3320A Boehringer Ingelheim Investigational Site

Castelnau-le-Lez, France

Location

352.2046.3320B Boehringer Ingelheim Investigational Site

Castelnau-le-Lez, France

Location

352.2046.3320C Boehringer Ingelheim Investigational Site

Castelnau-le-Lez, France

Location

352.2046.3335A Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

Location

352.2046.3314A Boehringer Ingelheim Investigational Site

Forbach, France

Location

352.2046.3301A Boehringer Ingelheim Investigational Site

Marseille, France

Location

352.2046.3333A Boehringer Ingelheim Investigational Site

Marseille, France

Location

352.2046.3326A Boehringer Ingelheim Investigational Site

Montpellier, France

Location

352.2046.3326C Boehringer Ingelheim Investigational Site

Montpellier, France

Location

352.2046.3325A Boehringer Ingelheim Investigational Site

Nantes, France

Location

352.2046.3325C Boehringer Ingelheim Investigational Site

Nantes, France

Location

352.2046.3325D Boehringer Ingelheim Investigational Site

Nantes, France

Location

352.2046.3334A Boehringer Ingelheim Investigational Site

Nantes, France

Location

352.2046.3324A Boehringer Ingelheim Investigational Site

Nîmes, France

Location

352.2046.3332A Boehringer Ingelheim Investigational Site

Nîmes, France

Location

352.2046.3332B Boehringer Ingelheim Investigational Site

Nîmes, France

Location

352.2046.3332C Boehringer Ingelheim Investigational Site

Nîmes, France

Location

352.2046.3331A Boehringer Ingelheim Investigational Site

Perpignan, France

Location

352.2046.3331B Boehringer Ingelheim Investigational Site

Perpignan, France

Location

352.2046.3331C Boehringer Ingelheim Investigational Site

Perpignan, France

Location

352.2046.3329A Boehringer Ingelheim Investigational Site

Saint-Laurent-du-Var, France

Location

352.2046.3329B Boehringer Ingelheim Investigational Site

Saint-Laurent-du-Var, France

Location

352.2046.3302A Boehringer Ingelheim Investigational Site

Saint-Pierre, France

Location

352.2046.3302B Boehringer Ingelheim Investigational Site

Saint-Pierre, France

Location

352.2046.3302C Boehringer Ingelheim Investigational Site

Saint-Pierre, France

Location

352.2046.3302D Boehringer Ingelheim Investigational Site

Saint-Pierre, France

Location

352.2046.3336A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

352.2046.3336B Boehringer Ingelheim Investigational Site

Toulouse, France

Location

352.2046.3336C Boehringer Ingelheim Investigational Site

Toulouse, France

Location

352.2046.3337A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

352.2046.49012 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

352.2046.49020 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

352.2046.49021 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

352.2046.49008 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

352.2046.49003 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

352.2046.49019 Boehringer Ingelheim Investigational Site

Cottbus, Germany

Location

352.2046.49002 Boehringer Ingelheim Investigational Site

Donaustauf, Germany

Location

352.2046.49013 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

352.2046.49025 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

352.2046.49023 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

352.2046.49024 Boehringer Ingelheim Investigational Site

Geesthacht, Germany

Location

352.2046.49022 Boehringer Ingelheim Investigational Site

Gelnhausen, Germany

Location

352.2046.49001 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

352.2046.49006 Boehringer Ingelheim Investigational Site

Heidelberg, Germany

Location

352.2046.49014 Boehringer Ingelheim Investigational Site

Immenhausen, Germany

Location

352.2046.49016 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

352.2046.49004 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

352.2046.49005 Boehringer Ingelheim Investigational Site

Marburg, Germany

Location

352.2046.49015 Boehringer Ingelheim Investigational Site

München, Germany

Location

352.2046.30003 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

352.2046.30004 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

352.2046.30005 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

352.2046.30007 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

352.2046.30008 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

352.2046.30011 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

352.2046.30012 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

352.2046.30006 Boehringer Ingelheim Investigational Site

Heraklion, Greece

Location

352.2046.30009 Boehringer Ingelheim Investigational Site

Larissa, Greece

Location

352.2046.30001 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

352.2046.30002 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

352.2046.36003 Boehringer Ingelheim Investigational Site

Cegléd, Hungary

Location

352.2046.36002 Boehringer Ingelheim Investigational Site

Deszk, Hungary

Location

352.2046.36004 Boehringer Ingelheim Investigational Site

Komárom, Hungary

Location

352.2046.36006 Boehringer Ingelheim Investigational Site

Pécs, Hungary

Location

352.2046.36001 Boehringer Ingelheim Investigational Site

Szarvas, Hungary

Location

352.2046.36005 Boehringer Ingelheim Investigational Site

Százhalombatta, Hungary

Location

352.2046.36011 Boehringer Ingelheim Investigational Site

Szigetszentmiklós, Hungary

Location

352.2046.39002 Boehringer Ingelheim Investigational Site

Catania, Italy

Location

352.2046.39007 Boehringer Ingelheim Investigational Site

Cona, Italy

Location

352.2046.39005 Boehringer Ingelheim Investigational Site

Foggia, Italy

Location

352.2046.39003 Boehringer Ingelheim Investigational Site

Modena, Italy

Location

352.2046.39006 Boehringer Ingelheim Investigational Site

Montescano (pv), Italy

Location

352.2046.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

352.2046.39004 Boehringer Ingelheim Investigational Site

Sesto S. Giovanni (mi), Italy

Location

352.2046.39008 Boehringer Ingelheim Investigational Site

Tradate (va), Italy

Location

352.2046.31004 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

352.2046.31001 Boehringer Ingelheim Investigational Site

Leeuwarden, Netherlands

Location

352.2046.31003 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

352.2046.31002 Boehringer Ingelheim Investigational Site

Veldhoven, Netherlands

Location

352.2046.64007 Boehringer Ingelheim Investigational Site

Auckland NZ, New Zealand

Location

352.2046.64003 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

352.2046.64004 Boehringer Ingelheim Investigational Site

Dunedin, New Zealand

Location

352.2046.64006 Boehringer Ingelheim Investigational Site

Hamilton, New Zealand

Location

352.2046.64001 Boehringer Ingelheim Investigational Site

Newtown Wellington NZ, New Zealand

Location

352.2046.64005 Boehringer Ingelheim Investigational Site

Otahuhu New Zealand, New Zealand

Location

352.2046.64002 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand

Location

352.2046.63001 Boehringer Ingelheim Investigational Site

Caloocan, Philippines

Location

352.2046.63009 Boehringer Ingelheim Investigational Site

City of Muntinlupa, Philippines

Location

352.2046.63003 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

352.2046.63004 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

352.2046.63005 Boehringer Ingelheim Investigational Site

Quezon, Philippines

Location

352.2046.63007 Boehringer Ingelheim Investigational Site

Quezon, Philippines

Location

352.2046.63006 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

352.2046.63008 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

352.2046.48006 Boehringer Ingelheim Investigational Site

Bytom, Poland

Location

352.2046.48003 Boehringer Ingelheim Investigational Site

Ostrow Wielkopolska, Poland

Location

352.2046.48001 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

352.2046.48002 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

352.2046.48009 Boehringer Ingelheim Investigational Site

Rzeszów, Poland

Location

352.2046.48011 Boehringer Ingelheim Investigational Site

Tarnowskie Góry, Poland

Location

352.2046.48005 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

352.2046.48007 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

Location

352.2046.07006 Boehringer Ingelheim Investigational Site

Ivanovo, Russia

Location

352.2046.07008 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

352.2046.07009 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

352.2046.07001 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

352.2046.07002 Boehringer Ingelheim Investigational Site

Samara, Russia

Location

352.2046.07003 Boehringer Ingelheim Investigational Site

Saratov, Russia

Location

352.2046.07004 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

352.2046.07005 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

352.2046.07011 Boehringer Ingelheim Investigational Site

Yekaterinburg, Russia

Location

352.2046.27002 Boehringer Ingelheim Investigational Site

Bellville, South Africa

Location

352.2046.27001 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

352.2046.27003 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

352.2046.27006 Boehringer Ingelheim Investigational Site

eManzimtoti, South Africa

Location

352.2046.27007 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

352.2046.27005 Boehringer Ingelheim Investigational Site

Somerset West, South Africa

Location

352.2046.27004 Boehringer Ingelheim Investigational Site

Tygerberg, South Africa

Location

352.2046.34008 Boehringer Ingelheim Investigational Site

Badajoz, Spain

Location

352.2046.34002 Boehringer Ingelheim Investigational Site

Barakaldo (Bilbao), Spain

Location

352.2046.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

352.2046.34004 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

352.2046.34009 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

352.2046.34006 Boehringer Ingelheim Investigational Site

Palma de Mallorca, Spain

Location

352.2046.34010 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, Spain

Location

352.2046.34013 Boehringer Ingelheim Investigational Site

Salt (Girona), Spain

Location

352.2046.34011 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

352.2046.88607 Boehringer Ingelheim Investigational Site

Dawan, Taiwan

Location

352.2046.88608 Boehringer Ingelheim Investigational Site

Dawan, Taiwan

Location

352.2046.88606 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

352.2046.88604 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

352.2046.88601 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

352.2046.88603 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

352.2046.2161A Boehringer Ingelheim Investigational Site

Aryanah, Tunisia

Location

352.2046.2162A Boehringer Ingelheim Investigational Site

Aryanah, Tunisia

Location

352.2046.2165A Boehringer Ingelheim Investigational Site

Sfax, Tunisia

Location

352.2046.2164A Boehringer Ingelheim Investigational Site

Sousse, Tunisia

Location

352.2046.2163A Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

352.2046.90009 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

352.2046.90019 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

352.2046.90016 Boehringer Ingelheim Investigational Site

Bursa, Turkey (Türkiye)

Location

352.2046.90010 Boehringer Ingelheim Investigational Site

Denizli, Turkey (Türkiye)

Location

352.2046.90003 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

352.2046.90004 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

352.2046.90006 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

352.2046.90008 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

352.2046.90012 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

352.2046.90017 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

352.2046.90011 Boehringer Ingelheim Investigational Site

Izmir, Turkey (Türkiye)

Location

352.2046.90014 Boehringer Ingelheim Investigational Site

Izmir, Turkey (Türkiye)

Location

352.2046.90018 Boehringer Ingelheim Investigational Site

Izmir, Turkey (Türkiye)

Location

352.2046.90005 Boehringer Ingelheim Investigational Site

İzmit, Turkey (Türkiye)

Location

352.2046.90007 Boehringer Ingelheim Investigational Site

Kayseri, Turkey (Türkiye)

Location

352.2046.90001 Boehringer Ingelheim Investigational Site

Mersin, Turkey (Türkiye)

Location

352.2046.90002 Boehringer Ingelheim Investigational Site

Samsun, Turkey (Türkiye)

Location

352.2046.38007 Boehringer Ingelheim Investigational Site

Ivano-Frankivsk, Ukraine

Location

352.2046.38002 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

352.2046.38003 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

352.2046.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

352.2046.38006 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

352.2046.38005 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

352.2046.38001 Boehringer Ingelheim Investigational Site

Vinnytsia, Ukraine

Location

352.2046.44008 Boehringer Ingelheim Investigational Site

Baillieston, Glasgow, United Kingdom

Location

352.2046.44009 Boehringer Ingelheim Investigational Site

Barnsley, United Kingdom

Location

352.2046.44018 Boehringer Ingelheim Investigational Site

Belfast, United Kingdom

Location

352.2046.44010 Boehringer Ingelheim Investigational Site

Birmingham, United Kingdom

Location

352.2046.44003 Boehringer Ingelheim Investigational Site

Cambridge, United Kingdom

Location

352.2046.44026 Boehringer Ingelheim Investigational Site

Chertsey, United Kingdom

Location

352.2046.44006 Boehringer Ingelheim Investigational Site

Chesterfield, United Kingdom

Location

352.2046.44012 Boehringer Ingelheim Investigational Site

Cottingham, Hull, United Kingdom

Location

352.2046.44028 Boehringer Ingelheim Investigational Site

Inverness, United Kingdom

Location

352.2046.44016 Boehringer Ingelheim Investigational Site

Isleworth, United Kingdom

Location

352.2046.44002 Boehringer Ingelheim Investigational Site

Liverpool, United Kingdom

Location

352.2046.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

352.2046.44017 Boehringer Ingelheim Investigational Site

Norwich, United Kingdom

Location

352.2046.44021 Boehringer Ingelheim Investigational Site

Sheffield, United Kingdom

Location

352.2046.44019 Boehringer Ingelheim Investigational Site

Sunderland, United Kingdom

Location

352.2046.44025 Boehringer Ingelheim Investigational Site

Windsor, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 32943047 DERIVED

• 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.

  PMID: 30545350 DERIVED

• 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.

  PMID: 27066739 DERIVED

• 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.

  PMID: 25196117 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Salmeterol Xinafoate; Fluticasone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

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".

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 10, 2015
• Results First Posted: February 10, 2015

Record last verified: 2015-02

Locations

GB (16); FR (33); AU (6); BE (11); TW (6); IT (8); TU (17); NZ (7); BU (8); HU (7); PL (8); GR (11); ES (9); PH (8); UA (7); DE (19); BR (5); CN (8); DK (3); NL (4); RU (9); ZA (7)