Chronic Obstructive Pulmonary DiseasePhase 3NCT00393458
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
A Phase 3 study testing Indacaterol and Formoterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 183 sites in 25 countries.
Trial summary
This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Indacaterol and Formoterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,732 participants
- Where
- 183 sitesin 25 countries
- Study dates
- Oct 2006to Jul 2008
- Phase
- Phase 3
- 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 and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:
- Smoking history of at least 20 pack years
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced volume capacity) < 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)
Who cannot join
- Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
- Patients who had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease.
- Patients with a history of asthma.
- Patients with diabetes type I or uncontrolled diabetes type II.
- Any patient with lung cancer or a history of lung cancer.
- Patients with a history of certain cardiovascular co-morbid conditions.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
183 sites in 25 countries.
183 sites in 25 countries
Germany38 sites
Novartis Investigator Site
Augsburg
Novartis Investigator Site
Bad Segeberg
Novartis Investigator Site
Bad Wörishofen
Novartis Investigator Site
Berlin
Novartis Investigator Site
Bielefeld
Novartis Investigator Site
Bochum
Novartis Investigator Site
Bonn
Novartis Investigator Site
Borstel
Novartis Investigator Site
Darmstadt
Novartis Investigator Site
Dortmund
Novartis Investigator Site
Erfurt
Novartis Investigator Site
Forchheim
Novartis Investigator Site
Frankfurt
Novartis Investigator Site
Gauting
Novartis Investigator Site
Geesthacht
Novartis Investigator Site
Gelsenkirchen
Novartis Investigator Site
Großhansdorf
Novartis Investigator Site
Gummersbach
Novartis Investigator Site
Hagen
Novartis Investigator Site
Hamburg
Novartis Investigator Site
Hanover
Novartis Investigator Site
Ilvesheim
Novartis Investigator Site
Kassel
Novartis Investigator Site
Kiel
Novartis Investigator Site
Leipzig
Novartis Investigator Site
Lübeck
Novartis Investigator Site
Lüdenscheid
Novartis Investigator Site
Mainz
Novartis Investigator Site
Marburg
Novartis Investigator Site
München
Novartis Investigator Site
Neumünster
Novartis
Nuremberg
Novartis Investigator Site
Oschersleben
Novartis Investigator Site
Rüdersdorf
Novartis Investigator Site
Schönefeld
Novartis Investigator Site
Strausberg
Novartis Investigator Site
Witten
Novartis Investigator Site
Wuppertal
Netherlands15 sites
Novartis Investigator Site
Almelo
Novartis Investigator Site
Amersfoort
Novartis
Arnhem
Novartis Investigator Site
Breda
Novartis Investigator Site
Ede
Novartis Investigator Site
Eindhoven
Novartis Investigator Site
Harderwijk
Novartis Investigator Site
Helmond
Novartis Investigator Site
Hengelo
Novartis Investigator Site
Hoorn
Novartis Investigator Site
Leeuwarden
Novartis Investigator Site
Rotterdam
Novartis Investigator Site
Sneek
Novartis Investigator Site
Veldhoven
Novartis Investigator Site
Zutphen
France12 sites
Novartis Investigator Site
Beuvry
Novartis Investigator Site
Chamalières
Novartis Investigator Site
Férolles-Attilly
Novartis Investigator Site
Grasse
Novartis Investigator Site
Marseille
Novartis Investigator Site
Montpellier
Novartis Investigator Site
Nice
Novartis Investigator Site
Nîmes
Novartis Investigator Site
Paris
Novartis Investigator Site
Perpignan
Novartis Investigator Site
Pessac
Novartis Investigator Site
Strasbourg
Italy11 sites
Novartis Investigator Site
Ancona
Novartis Investigator Site
Catania
Novartis Investigator Site
Ferrara
Novartis Investigator Site
Florence
Novartis Investigator Site
Foggia
Novartis Investigator Site
Genova
Novartis Investigator Site
Milan
Novartis
Milan
Novartis Investigator Site
Pisa
Novartis Investigator Site
Roma
Novartis Investigator Site
Siena
Spain11 sites
Novartis Investigator Site
Alicante
Novartis Investigator Site
Barcelona
Novartis
Barcelona
Novartis Investigator Site
Begonte
Novartis Investigator Site
Cáceres
Novartis Investigative Site
Madrid
Novartis Investigator Site
Mataró
Novartis Investigator Site
Petrel
Novartis Investigator Site
Ponferrada
Novartis Investigator Site
Terrassa
Novartis Investigator Site
Valencia
United Kingdom11 sites
Novartis Investigator Site
Belfast
Novartis Investigator Site
Bexhill-on-Sea
Novartis Investigator Site
Blackpool
Novartis Investigator Site
Chertsey
Novartis Investigator Site
Glasgow
Novartis Investigator Site
Leicester
Novartis Investigator Site
London
Novartis Investigator Site
Manchester
Novartis Investigator Site
Newcastle upon Tyne
Novartis Investigator Site
Slough
Novartis Investigator Site
Swansea
Czechia7 sites
Novartis Investigator Site
Cvikov
Novartis Investigator Site
Kyjov
Novartis Investigator Site
Ostrava Poruba
Novartis Investigator Site
Pardubice
Novartis
Prague
Novartis Investigator Site
Tábor
Novartis Investigator Site
Žatec
Denmark6 sites
Novartis Investigator Site
Aarhus
Novartis
Copenhagen
Novartis Investigator Site
Hellerup
Novartis Investigator Site
Hvidovre
Novartis Investigator Site
Molleparkvej
Novartis Investigator Site
Odense
Hungary6 sites
Novartis Investigator Site
Budapest
Novartis
Budapest
Novartis Investigator Site
Deszk
Novartis Investigator Site
Mátraháza
Novartis Investigator Site
Mosdós
Novartis Investigator Site
Sopron
Russia6 sites
Novartis Investigator Site
Kazan'
Novartis Investigator Site
Moscow
Novartis
Moscow
Novartis Investigator Site
Saint Petersburg
Novartis Investigator Site
Samara
Novartis Investigator Site
Yekaterinburg
Turkey (Türkiye)6 sites
Novartis Investigator Site
Ankara
Novartis Investigator Site
Bursa
Novartis
Istanbul
Novartis Investigator Site
Izmir
Novartis Investigator Site
Mersin
Novartis Investigator Site
Yenişehir
Argentina5 sites
Novartis Investigator Site
Buenos Aires
Novartis
Buenos Aires
Novartis Investigator Site
Mendoza
Novartis Investigator Site
San Miguel
Novartis Investigator Site
Santa Fe
Lithuania5 sites
Novartis Investigator Site
Alytus
Novartis Investigator Site
Kaunas
Novartis
Kaunas
Novartis Investigator Site
Klaipėda
Novartis Investigator Site
Vilnius
Slovakia5 sites
Novartis Investigator Site
Banská Bystrica
Novartis Investigator Site
Bratislava
Novartis
Bratislava
Novartis Investigator Site
Košice
Novartis Investigator Site
Partizánske
South Korea5 sites
Novartis Investigator Site
Kyunggi
Novartis Investigator Site
Seoul
Novartis
Seoul
Novartis Investigator Site
Suwon
Novartis Investigator Site
Uijeongbu-si
Switzerland5 sites
Novartis Investigator Site
Aarau
Novartis Investigator Site
Basel
Novartis Investigator Site
Locarno
Novartis Investigator Site
Münchenstein
Novartis Investigator Site
Zurich
Egypt4 sites
Novartis Investigator Site
Alexandria
Novartis Investigator Site
Asyut
Novartis Investigator Site
Cairo
Novartis
Cairo
Israel4 sites
Novartis Investigator Site
Jerusalem
Novartis
Petah Tikva
Novartis Investigator Site
Rehovot
Novartis Investigator Site
Tel HaShomer
Latvia4 sites
Novartis Investigator Site
Daugavpils
Novartis Investigator Site
Jēkabpils
Novartis Investigator Site
Riga
Novartis
Riga
Romania4 sites
Novartis
Bucharest
Novartis Investigator Site
Cluj-Napoca
Novartis Investigator Site
Iași
Novartis Investigator Site
Timișoara
Chile3 sites
Novartis Investigator Site
Rancagua
Novartis
Santiago
Novartis Investigator Site
Viña del Mar
Colombia3 sites
Novartis Investigator Site
Barranquilla
Novartis
Bogotá
Novartis Investigator Site
Medellín
Ecuador3 sites
Novartis Investigator Site
Guayaquil
Novartis Investigator Site
Quito
Novartis
Quito
About this study
Official title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol, Formoterol, Placebo to indacaterol, Placebo to formoterol
- Keywords
- chronic obstructive pulmonary disease, COPD, indacaterol, long-acting β2 agonist
- 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.
IndacaterolDrug
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
FormoterolDrug
Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
Placebo to indacaterolDrug
Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Placebo to formoterolDrug
Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol 300 μg plus placebo to formoterol | Experimental | Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to formoterol |
| Indacaterol 600 μg plus placebo to formoterol | Experimental | Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to formoterol |
| Formoterol 12 μg plus placebo to indacaterol | Active comparator | Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Formoterol; Drug: Placebo to indacaterol |
| Placebo to indacaterol plus placebo to formoterol | Placebo comparator | Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Placebo to indacaterol; Drug: Placebo to formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Measured: Week 12 + 1 day, Day 85
Secondary outcomes (1)
Percentage of Days of Poor Control During 52 Weeks of Treatment
Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Measured: Baseline to end of study (Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2008
- Study completionJul 2008
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 (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,732 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Investigator Site, Principal investigator, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393458
- Sponsor's protocol ID
- CQAB149B2334
- Status last verified
- Jul 2011
- First submitted
- 25 Oct 2006
- Last updated
- 18 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.
PubMed 22206353Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.
PubMed 22003288Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.
PubMed 21397482Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.
PubMed 21227674Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.
PubMed 20522841
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
- ClinicalTrials.gov ID
- NCT00393458
- Acronym / sponsor ID
- CQAB149B2334
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, COPD, indacaterol, long-acting β2 agonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,732 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Oct 2006 (estimated)
- Results
- Posted 18 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Indacaterol 300 μg plus placebo to formoterol | Experimental | Drug: Indacaterol, Drug: Placebo to formoterolPatients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Indacaterol 600 μg plus placebo to formoterol | Experimental | Drug: Indacaterol, Drug: Placebo to formoterolPatients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Formoterol 12 μg plus placebo to indacaterol | Active comparator | Drug: Formoterol, Drug: Placebo to indacaterolPatients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Placebo to indacaterol plus placebo to formoterol | Placebo comparator | Drug: Placebo to indacaterol, Drug: Placebo to formoterolPatients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
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 and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:
Key exclusion criteria (8 listed)
- Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
- Patients who had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease.
- Patients with a history of asthma.
- Patients with diabetes type I or uncontrolled diabetes type II.
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 |
|---|---|---|
| IndacaterolIndacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). | Drug | Indacaterol 300 μg plus placebo to formoterol, Indacaterol 600 μg plus placebo to formoterol |
| FormoterolFormoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®). | Drug | Formoterol 12 μg plus placebo to indacaterol |
| Placebo to indacaterolPlacebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). | Drug | Formoterol 12 μg plus placebo to indacaterol, Placebo to indacaterol plus placebo to formoterol |
| Placebo to formoterolPlacebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®). | Drug | Indacaterol 300 μg plus placebo to formoterol, Indacaterol 600 μg plus placebo to formoterol, Placebo to indacaterol plus placebo to formoterol |
Primary outcome
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
Time frame: Week 12 + 1 day, Day 85
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
1 secondary outcome
Percentage of Days of Poor Control During 52 Weeks of Treatment
Time frame: Baseline to end of study (Week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22206353Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.
- Derived from this study: PubMed 22003288Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.
- Derived from this study: PubMed 21397482Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.
- Derived from this study: PubMed 21227674Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.
- Derived from this study: PubMed 20522841Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.
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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Novartis Investigator Site principal investigator
Novartis
183 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indacaterol and Formoterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 183 sites in 25 countries.
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 8 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 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 183 sites in Germany, Netherlands, France, Italy, Spain and 20 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Aug 2011). 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?
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (time frame: Week 12 + 1 day, Day 85). 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 NCT00393458, which also lists 5 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 18 Aug 2011.