Chronic Obstructive Pulmonary DiseasePhase 3INTENSITYNCT00900731
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Indacaterol 150 μg and Tiotropium 18 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 212 sites in 22 countries.
Trial summary
This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period. 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 150 μg and Tiotropium 18 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,598 participants
- Where
- 212 sitesin 22 countries
- Study dates
- Jun 2009to Mar 2010
- 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
- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
- a) Smoking history of at least 10 pack-years
- b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
- c) Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Who cannot join
- Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
- Patients who have 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 comorbid conditions
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
212 sites in 22 countries.
212 sites in 22 countries
Germany35 sites
Novartis Investigator Site
Bergisch Gladbach
Novartis Investigator Site
Berlin
Novartis Investigator Site
Bochum
Novartis Investigator Site
Bonn
Novartis Investigator Site
Buchholz
Novartis Investigator Site
Coburg
Novartis Investigator Site
Düren
Novartis Investigator Site
Eggenfelden
Novartis Investigator Site
Eschwege
Novartis Investigator Site
Euskirchen
Novartis Investigator Site
Freudenberg
Novartis Investigator Site
Fürth
Novartis Investigator Site
Gelsenkirchen
Novartis Investigator Site
Gummersbach
Novartis Investigator Site
Hagen
Novartis Investigator Site
Halle
Novartis Investigator Site
Hamburg
Novartis Investigator Site
Hanover
Novartis Investigator Site
Hoyerswerda
Novartis Investigator Site
Kassel
Novartis Investigative Site
Landsberg
Novartis Investigator Site
Leipzig
Novartis Investigator Site
Mainz
Novartis Investigator Site
Munich
Novartis Investigator Site
Oranienburg
Novartis Investigator Site
Radebeul
Novartis Investigator Site
Ratingen
Novartis Investigator Site
Ruhmannsfelden
Novartis Investigator Site
Rüsselsheim am Main
Novartis Investigator Site
Solingen
Novartis Investigator Site
Stockach
Novartis Investigator Site
Teterow
Novartis Investigator Site
Vilshofen
Novartis Investigator Site
Wallerfing
Novartis Investigator Site
Wissen
United States25 sites
Novartis Investigative Site
Albany, New York, 12205
Novartis Investigator Site
Anaheim, California, 92801
Novartis Investigative Site
Birmingham, Alabama, 35209
Novartis Investigative Site
Charlotte, North Carolina, 28207
Novartis Investigative Site
Columbus, Ohio, 43214
Novartis Investigative Site
Evansville, Indiana, 47710
Novartis Investigator Site
Fort Collins, Colorado, 80528
Novartis Investigative Site
Henderson, Nevada, 89014
Novartis Investigator Site
Jasper, Alabama, 35501
Novartis Investigative Site
Lafayette, Louisiana, 70503
Novartis Investigative Site
Larchmont, New York, 10538
Novartis Investigative Site
Lincoln, Nebraska, 68510
Novartis Investigative Site
New York, New York, 10016
Novartis Investigator Site
Normal, Illinois, 61761
Novartis Investigative Site
Phoenix, Arizona, 85050
Novartis Investigative Site
Richmond, Virginia, 23229
Novartis Investigative Center
Saint Charles, Missouri, 63301
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
South Miami, Florida, 33143
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigator Site
Stockton, California, 95207
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Tucson, Arizona, 85723
Novartis Investigator Site
Walnut Creek, California, 94598
Novartis Investigator Site
Wheat Ridge, Colorado, 80033
Spain19 sites
Novartis Investigative Site
Alcorcón
Novartis Investigator Site
Alicante
Novartis Investigator Site
Badalona
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Begonte
Novartis Investigator Site
Burgos
Novartis Investigator Site
Cáceres
Novartis Investigator Site
Canet de Mar
Novartis Investigator Site
el Prat de Llobregat
Novartis Investigative Site
Fuenlabrada
Novartis Investigative Site
Girona
Novartis Investigative Site
Madrid
Novartis Investigator Site
Mataró
Novartis Investigator Site
Plasencia
Novartis Investigative Site
Ponferrada
Novartis Investigative Site
Pontevedra
Novartis Investigative Site
Santander
Novartis Investigative Site
Valencia
Novartis Investigative Site
Vila-real
Norway15 sites
Novartis Investigative Site
Ålesund
Novartis Investigator Site
Ålesund
Novartis Investigator Site
Drammen
Novartis Investigator Site
Follebu
Novartis Investigative Site
Kongsberg
Novartis Investigator Site
Kongsberg
Novartis Investigator Site
Kongsvinger
Novartis Investigator Site
Lierskogen
Novartis Investigative Site
Oslo
Novartis Investigator Site
Oslo
Novartis Investigator Site
Sandvika
Novartis Investigative Site
Skedsmokorset
Novartis Investigator Site
Stavanger
Novartis Investigative Site
Trondheim
Novartis Investigator Site
Trondheim
France14 sites
Novartis Investigative Site
Ambroise
Novartis Investigative Site
Antibes
Novartis Investigator Site
Beuvry
Novartis Investigator Site
Ferolles-Attily
Novartis Investigative Site
Montpellier
Novartis Investigator Site
Nantes
Novartis Investigative Site
Nice
Novartis Investigative Site
Nîmes
Novartis Investigative Site
Paris
Novartis Investigator Site
Paris
Novartis Investigative Site
Pessac
Novartis Investigator Site
Pierre-Bénite
Novartis Investigative Site
Suresnes
Novartis Investigator Site
Vandoeuvre Les Nancys
Turkey (Türkiye)11 sites
Novartis Investigator Site
Altunizade
Novartis Investigator Site
Ankara
Novartis Investigative Site
Aydin
Novartis Investigator Site
Büyükçekmece / Ýstanbul
Novartis Investigative Site
Fatih / Istanbul
Novartis Investigator Site
Istanbul
Novartis Investigator Site
Kahramanmaraş
Novartis Investigative Site
Mecidiyekoy/Istanbul
Novartis Investigative Site
Mersin
Novartis Investigative Site
Soke / Aydin
Novartis Investigative Site
Yenisehir/Izmir
United Kingdom10 sites
Novartis Investigator Site
Ash Vale
Novartis Investigator Site
Ashford
Novartis Investigator Site
Bolton
Novartis Investigator Site
Boscastle
Novartis Investigator Site
Bradford
Novartis Investigator Site
Chertsey
Novartis Investigator Site
East Horsley
Novartis Investigator Site
Newcastle upon Tyne
Novartis Investigator Site
Plymouth
Novartis Investigator Site
Watford
Belgium9 sites
Novartis Investigator Site
Brussels
Novartis Investigator Site
Gilly
Novartis Investigator Site
Jambes
Novartis Investigator Site
Jette
Novartis Investigator Site
Liège
Novartis Investigator Site
Montigny-le-Tilleul
Novartis Investigator Site
Ostend
Novartis Investigator Site
Sankt Vith
Novartis Investigator Site
Yvoir
Russia9 sites
Novartis Investigator Site
Barnaul
Novartis Investigator Site
Kazan'
Novartis Investigator Site
Novosibirsk
Novartis Investigator Site
Petrozavodsk
Novartis Investigator Site
Ryazan
Novartis Investigative Site
Saint Petersburg
Novartis Investigator Site
Saint Petersburg
Novartis Investigator Site
Samara
Novartis Investigator Site
Yekaterinburg
Italy8 sites
Novartis Investigator Site
Ancona
Novartis Investigator Site
Foggia
Novartis Investigative Site
Milan
Novartis Investigator Site
Milan
Novartis Investigative Site
Pavia
Novartis Investigator Site
Pavia
Novartis Investigative Site
Pisa
Novartis Investigator Site
Pisa
Canada7 sites
Novartis Investigator Site
Calgary
Novartis Investigative Site
Greater Sudbury
Novartis Investigative Site
Mississauga
Novartis Investigative Site
Moncton
Novartis Investigative Site
New Market
Novartis Investigative SIte
Québec
Novartis Investigative Site
Saint Romuald
Denmark7 sites
Novartis Investigator Site
Aalborg
Novartis Investigator Site
Frederiksberg
Novartis Investigator Site
Næstved
Novartis Investigator Site
Roskilde
Novartis Investigator Site
Sønderborg
Novartis Investigator Site
Værløse
Novartis Investigator Site
Viborg
Poland7 sites
Novartis Investigator Site
Gdansk
Novartis Investigator Site
Katowice
Novartis Investigative Site
Krakow
Novartis Investigator Site
Krakow
Novartis Investigator Site
Piekary Śląskie
Novartis Investigator Site
Warsaw
Novartis Investigator Site
Wroclaw
Slovakia7 sites
Novartis Investigator Site
Bratislava
Novartis Investigative Site
Košice
Novartis Investigator Site
Košice
Novartis Investigator Site
Kráľovský Chlmec
Novartis Investigator Site
Nitra
Novartis Investigative Site
Prešov
Novartis Investigator Site
Zvolen
Finland6 sites
Novartis Investigator Site
Helsinki
Novartis Investigator Site
Jyväskylä
Novartis Investigator Site
Lahti
Novartis Investigator Site
OYS
Novartis Investigator Site
Pori
Novartis Investigator Site
Turku
Hungary6 sites
Novartis Investigative Site
Budapest
Novartis Investigator Site
Budapest
Novartis Investigator Site
Debrecen
Novartis Investigative Site
Farkasgyepű
Novartis Investigative Site
Gödöllő
Novartis Investigator Site
Szolnok
Switzerland5 sites
Novartis Investigator Site
Basel
Novartis Investigator Site
Bellinzona
Novartis Investigator Site
Lugano
Novartis Investigator Site
Muenchenstein
Novartis Investigative Site
Zurich
Austria3 sites
Novartis Investigator Site
Feldbach
Novartis Investigator Site
Gänserndorf
Novartis Investigator Site
Hallein
Colombia3 sites
Novartis Investigator Site
Barranquilla
Novartis Investigator Site
Bogotá
Novartis Investigator Site
Medellín
Mexico3 sites
Novartis Investigative Site
Huxquilucan
Novartis Investigator Site
Mexico City
Novartis Investigative Site
San Luis Potosí City
Israel2 sites
Novartis Investigator Site
Haifa
Novartis Investigator Site
Petah Tikva
About this study
Official title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol 150 μg, Tiotropium 18 μg, Placebo to indacaterol, Placebo to tiotropium
- Keywords
- COPD, indacaterol, beta 2 agonist, tiotropium
- 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.
Indacaterol 150 μgDrug
Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Tiotropium 18 μgDrug
Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
Placebo to indacaterolDrug
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Placebo to tiotropiumDrug
Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol 150 µg | Experimental | Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. Receives: Drug: Indacaterol 150 μg; Drug: Placebo to tiotropium |
| Tiotropium 18 µg | Active comparator | Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. Receives: Drug: Tiotropium 18 μg; Drug: Placebo to indacaterol |
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 End of Treatment (Week 12)
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Measured: End of treatment (Week 12)
Secondary outcomes (7)
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
Spirometry was conducted according to internationally accepted standards. FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Measured: 5 minutes to 4 hours post-dose at the end of treatment (week 12)
Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment
TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Measured: 12 weeks
Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning \& psychological disturbances resulting from airway disease). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Measured: 12 weeks
Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Measured: Baseline, up to 12 weeks
Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant. Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Measured: Baseline, up to 12 weeks
Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary. The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant. Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Measured: Baseline, up to 12 weeks
Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment
A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication. The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100. Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionMar 2010
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 (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900731
- Sponsor's protocol ID
- CQAB149B2350
- Acronym
- INTENSITY
- Status last verified
- Jul 2011
- First submitted
- 12 May 2009
- Last updated
- 19 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, Kramer B; INTENSITY study investigators. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011 Oct;38(4):797-803. doi: 10.1183/09031936.00191810. Epub 2011 May 26.
PubMed 21622587
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
- ClinicalTrials.gov ID
- NCT00900731
- Acronym / sponsor ID
- INTENSITY / CQAB149B2350
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, indacaterol, beta 2 agonist, tiotropium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,598 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Posted 19 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 compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indacaterol 150 µg | Experimental | Drug: Indacaterol 150 μg, Drug: Placebo to tiotropiumParticipants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. |
| Tiotropium 18 µg | Active comparator | Drug: Tiotropium 18 μg, Drug: Placebo to indacaterolParticipants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
- a) Smoking history of at least 10 pack-years
- b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
- c) Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Key exclusion criteria (8 listed)
- Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
- Patients who have 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 |
|---|---|---|
| Indacaterol 150 μgIndacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). | Drug | Indacaterol 150 µg |
| Tiotropium 18 μgTiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®). | Drug | Tiotropium 18 µg |
| Placebo to indacaterolPlacebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). | Drug | Tiotropium 18 µg |
| Placebo to tiotropiumPlacebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®). | Drug | Indacaterol 150 µg |
Primary outcome
Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)
Time frame: End of treatment (Week 12)
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
7 secondary outcomes
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
Time frame: 5 minutes to 4 hours post-dose at the end of treatment (week 12)
Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment
Time frame: 12 weeks
Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
Time frame: 12 weeks
Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Time frame: Baseline, up to 12 weeks
Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Time frame: Baseline, up to 12 weeks
Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Time frame: Baseline, up to 12 weeks
Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment
Time frame: Up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21622587Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, Kramer B; INTENSITY study investigators. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011 Oct;38(4):797-803. doi: 10.1183/09031936.00191810. Epub 2011 May 26.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
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 Pharmaceuticals study director
Novartis Pharmaceuticals
212 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indacaterol 150 μg and Tiotropium 18 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 212 sites in 22 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 19 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 212 sites in Germany, United States, Spain, Norway, France and 17 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 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 19 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 End of Treatment (Week 12) (time frame: End of treatment (Week 12)). 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 NCT00900731, which also lists 1 linked publication.
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 19 Aug 2011.