A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363896
• Other study ID #: CT000740
• Secondary ID: ACCLAIM IM/34273
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2006
• Last updated: May 28, 2015
• Start date: August 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Males and females aged = 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

• History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium bromide
Aclidinium bromide 200 µg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
• Placebo
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Locations

Country	Name	City	State
Andorra	Almirall Investigational Sites#947	Escaldes
Austria	Almirall Investigational Sites#645	Graz
Austria	Almirall Investigational Sites#646	Innsbruck
Austria	Almirall Investigational Sites#644	Linz
Austria	Almirall Investigational Sites#647	Wien
Austria	Almirall Investigational Sites#649	Wien
Belgium	Almirall Investigational Sites#110	Aalst
Belgium	Almirall Investigational Sites#394	Brussels
Belgium	Almirall Investigational Sites#651	Edegem
Belgium	Almirall Investigational Sites#393	Namur
Bulgaria	Almirall Investigational Sites#658	Burgas
Bulgaria	Almirall Investigational Sites#653	Pleven
Bulgaria	Almirall Investigational Sites#654	Plovdiv
Bulgaria	Almirall Investigational Sites#656	Russe
Bulgaria	Almirall Investigational Sites#652	Sofia
Bulgaria	Almirall Investigational Sites#657	Sofia
Bulgaria	Almirall Investigational Sites#971	Sofia
Bulgaria	Almirall Investigational Sites#972	Sofia
Bulgaria	Almirall Investigational Sites#655	Varna
Bulgaria	Almirall Investigational Sites#953	Veliko Tarnovo
Czech Republic	Almirall Investigational Sites#664	Lovosice
Czech Republic	Almirall Investigational Sites#660	Neratovice
Czech Republic	Almirall Investigational Sites#662	Plzen
Czech Republic	Almirall Investigational Sites#666	Prague
Czech Republic	Almirall Investigational Sites#661	Praha
Czech Republic	Almirall Investigational Sites#665	Tabor
Czech Republic	Almirall Investigational Sites#659	Tremosna
Czech Republic	Almirall Investigational Sites#954	Zatec
Denmark	Almirall Investigational Sites#398	Aalborg
Denmark	Almirall Investigational Sites#390	Århus C
Denmark	Almirall Investigational Sites#397	Odense C.
France	Almirall Investigational Sites#594	Beuvry
France	Almirall Investigational Sites#593	Brest Cedex
France	Almirall Investigational Sites#750	Grasse
France	Almirall Investigational Sites#669	Montpellier,cedex 5
France	Almirall Investigational Sites#672	Paris
France	Almirall Investigational Sites#948	Perpignan Cedex
France	Almirall Investigational Sites#549	Rouen , Cedex
France	Almirall Investigational Sites#671	Strasbourg Cedex
France	Almirall Investigational Sites#752	Vieux Conde
Germany	Almirall Investigational Sites#678	Bad Wörishofen
Germany	Almirall Investigational Sites#680	Berlin
Germany	Almirall Investigational Sites#758	Berlin
Germany	Almirall Investigational Sites#765	Berlin
Germany	Almirall Investigational Sites#677	Berlin-Spandau
Germany	Almirall Investigational Sites#681	Bonn
Germany	Almirall Investigational Sites#191	Grosshansdorf
Germany	Almirall Investigational Sites#766	Hamburg
Germany	Almirall Investigational Sites#757	Jena
Germany	Almirall Investigational Sites#675	Mainz
Hungary	Almirall Investigational Sites#684	Budapest
Hungary	Almirall Investigational Sites#683	Debrecen
Hungary	Almirall Investigational Sites#687	Debrecen
Hungary	Almirall Investigational Sites#688	Nyiregyhaza
Hungary	Almirall Investigational Sites#686	Szekesfehervar
Hungary	Almirall Investigational Sites#689	Szombathely
Hungary	Almirall Investigational Sites#682	Tatabanya
Hungary	Almirall Investigational Sites#685	Torokbalint
Italy	Almirall Investigational Sites#459	Genova
Italy	Almirall Investigational Sites#774	Milano
Italy	Almirall Investigational Sites#286	Modena
Italy	Almirall Investigational Sites#694	Napoli
Italy	Almirall Investigational Sites#635	Perugia
Italy	Almirall Investigational Sites#777	Pordenone
Netherlands	Almirall Investigational Sites#346	Breda
Netherlands	Almirall Investigational Sites#551	Eindhoven
Netherlands	Almirall Investigational Sites#348	Hengelo
Netherlands	Almirall Investigational Sites#695	Hoofddorp
Poland	Almirall Investigational Sites#698	Lodz
Poland	Almirall Investigational Sites#700	Lodz
Poland	Almirall Investigational Sites#697	Torun
Poland	Almirall Investigational Sites#696	Warszawa
Poland	Almirall Investigational Sites#699	Warszawa
Poland	Almirall Investigational Sites#702	Warszawa
Poland	Almirall Investigational Sites#706	Wroclaw
Poland	Almirall Investigational Sites#705	Zabrze
Poland	Almirall Investigational Sites#701	Zawadzkie
Romania	Almirall Investigational Sites#962	Brasov
Romania	Almirall Investigational Sites#714	Bucharest
Romania	Almirall Investigational Sites#970	Bucuresti
Romania	Almirall Investigational Sites#713	Cluj-Napoca
Romania	Almirall Investigational Sites#712	Iasi
Romania	Almirall Investigational Sites#961	Judetul Brasov
Romania	Almirall Investigational Sites#709	Palazu Mare
Romania	Almirall Investigational Sites#711	Targu Mures
Romania	Almirall Investigational Sites#715	Timisoara
Russian Federation	Almirall Investigational Sites#462	Moscow
Russian Federation	Almirall Investigational Sites#540	Moscow
Russian Federation	Almirall Investigational Sites#582	Moscow
Russian Federation	Almirall Investigational Sites#716	Moscow
Russian Federation	Almirall Investigational Sites#719	Moscow
Russian Federation	Almirall Investigational Sites#721	Moscow
Russian Federation	Almirall Investigational Sites#722	Moscow
Russian Federation	Almirall Investigational Sites#785	Moscow
Russian Federation	Almirall Investigational Sites#967	Moscow
Russian Federation	Almirall Investigational Sites#976	Moscow
Russian Federation	Almirall Investigational Sites#977	Moscow
Russian Federation	Almirall Investigational Sites#717	Moscow region
Russian Federation	Almirall Investigational Sites#465	Saint Petersburg
Russian Federation	Almirall Investigational Sites#543	Saint Petersburg
Russian Federation	Almirall Investigational Sites#588	Saint Petersburg
Russian Federation	Almirall Investigational Sites#720	Saint Petersburg
Russian Federation	Almirall Investigational Sites#786	Saint Petersburg
Russian Federation	Almirall Investigational Sites#787	Saint Petersburg
Russian Federation	Almirall Investigational Sites#963	Saint Petersburg
Russian Federation	Almirall Investigational Sites#965	Saint Petersburg
Russian Federation	Almirall Investigational Sites#966	Saint Petersburg
Russian Federation	Almirall Investigational Sites#969	saint Petersburg
Russian Federation	Almirall Investigational Sites#972	Saint Petersburg
Russian Federation	Almirall Investigational Sites#975	Saint Petersburg
Russian Federation	Almirall Investigational Sites#718	Sochi
Spain	Almirall Investigational Sites#16	Badalona
Spain	Almirall Investigational Sites#317	Barcelona
Spain	Almirall Investigational Sites#7	Barcelona
Spain	Almirall Investigational Sites#61	Madrid
Spain	Almirall Investigational Sites#938	Málaga
Spain	Almirall Investigational Sites#727	Palma de Mallorca
Spain	Almirall Investigational Sites#723	San Juan de Alicante
Spain	Almirall Investigational Sites#725	Terrassa
United Kingdom	Almirall Investigational Sites#738	Bedford
United Kingdom	Almirall Investigational Sites#42	Bristol
United Kingdom	Almirall Investigational Sites#734	Cottingham
United Kingdom	Almirall Investigational Sites#735	Doncaster
United Kingdom	Almirall Investigational Sites#788	Exeter
United Kingdom	Almirall Investigational Sites#737	Hereford
United Kingdom	Almirall Investigational Sites#37	London
United Kingdom	Almirall Investigational Sites#784	London
United Kingdom	Almirall Investigational Sites#730	Newcastle upon Tyne
United Kingdom	Almirall Investigational Sites#731	Peterborough
United Kingdom	Almirall Investigational Sites#728	Solihull
United Kingdom	Almirall Investigational Sites#732	Suffolk
United Kingdom	Almirall Investigational Sites#736	Windsor

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Forest Laboratories

Countries where clinical trial is conducted

Andorra,  Austria,  Belgium,  Bulgaria,  Czech Republic,  Denmark,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Romania,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough FEV1 (L) at 28 Weeks on Treatment	Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks	Week 28	No
Primary	Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment	Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks	Week 12	No
Secondary	Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment	Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.	Week 52	No
Secondary	Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment	Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score	52 weeks	No

External Links

•   Co-Sponsor web site
•   Sponsor web site