Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— INTRUST1Official title:
A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)
Status | Completed |
Enrollment | 1134 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) and: 1. Smoking history of at least 10 pack-years 2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) = 65% and = 30% of the predicted normal value 3. Post-bronchodilator FEV1/FVC (force vital capacity) < 70% Exclusion Criteria: - Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period - Patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period - Patients with a body mass index less than 15 or more than 40 kg/m^2 - 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Cordoba | |
Argentina | Novartis Investigative Site | Corrientes | |
Argentina | Novartis Investigative SIte | Mendoza | |
Argentina | Novartis Investigative Site | Rosario | |
Australia | Novartis Investigator Site | Box Hill | |
Australia | Novartis Investigator Site | Clayton | |
Australia | Novartis Investigator Site | Garran | |
Australia | Novartis Investigator Site | Glebe | |
Australia | Novartis Investigator Site | Kogarah | |
Australia | Novartis Investigator Site | Nedlands | |
Colombia | Novartis Investigative Site | Barranquilla | |
Colombia | Novartis Investigative Site | Bogota | |
Colombia | Novartis Investigator Site | Bogota | |
Colombia | Novartis Investigative Site | Medellin | |
Denmark | Novartis Investigator Site | Copenhagen | |
Denmark | Novartis Investigator Site | Fredericia | |
Denmark | Novartis Investigator Site | Silkeborg | |
Denmark | Novartis Investigator Site | Soeborg | |
Denmark | Novartis Investigator Site | Vejle | |
Germany | Novartis Investigator Site | Berlin | |
Germany | Novartis Investigator Site | Cottbus | |
Germany | Novartis Investigator Site | Donaustauf | |
Germany | Novartis Investigator Site | Dortmund | |
Germany | Novartis Investigator Site | Erfurt | |
Germany | Novartis Investigator Site | Frankfurt | |
Germany | Novartis Investigator Site | Gelnhausen | |
Germany | Novartis Investigator Site | Grosshansdorf | |
Germany | Novartis Investigator Site | Hannover | |
Germany | Novartis Investigator Site | Heidelberg | |
Germany | Novartis Investigator Site | Leipzig | |
Germany | Novartis Investigator Site | Mainz | |
Germany | Novartis Investigator Site | Neu-Ulm | |
Germany | Novartis Investigator Site | Neuss | |
Germany | Novartis Investigator Site | Potsdam | |
Germany | Novartis Investigator Site | Rostock | |
Germany | Novartis Investigator Site | Schwabach | |
Germany | Novartis Investigator Site | Schwetzingen | |
Germany | Novartis Investigator Site | Straussberg | |
Germany | Novartis Investigative Site | Wiesbaden | |
Germany | Novartis Investigator Site | Wuppertal | |
Guatemala | Novartis Investigative Site | Guatemala | |
Guatemala | Novartis Investigative Site | Guatemala City | |
Mexico | Novartis Investigative Site | Guadalajara | |
Mexico | Novartis Investigator Site | Mexico City | |
Mexico | Novartis Investigative Site | Monterrey | |
Mexico | Novartis Investigative Site | Zapopan | |
Philippines | Novartis Investigator Site | Manila | |
South Africa | Novartis Investigator Site | Amanzimtoti | |
South Africa | Novartis Investigator Site | Cape Town | |
South Africa | Novartis Investigator Site | Johannesburg | |
South Africa | Novartis Investigator Site | Midrand | |
South Africa | Novartis Investigator Site | Umkomaas | |
Spain | Novartis Investigative Site | Alicante | |
Spain | Novartis Investigator Site | Barcelona | |
Spain | Novartis Investigator Site | Begonte | |
Spain | Novartis Investigator Site | Cadiz | |
Spain | Novartis Investigator Site | Granollers | |
Spain | Novartis Investigative Site | Jaén | |
Spain | Novartis Investigator Site | La Coruna | |
Spain | Novartis Investigator Site | Leon | |
Spain | Novartis Investigator Site | Madrid | |
Spain | Novartis Investigator Site | Pamplona | |
Spain | Novartis Investigator Site | Torrelavega | |
Spain | Novartis Investigator Site | Valencia | |
Spain | Novartis Investigator Site | Vigo | |
Turkey | Novartis Investigator Site | Antalya | |
Turkey | Novartis Investigator Site | Canakkale | |
Turkey | Novartis Investigator Site | Isparta | |
Turkey | Novartis Investigator Site | Istanbul | |
Turkey | Novartis Investigator Site | Kartal | |
Turkey | Novartis Investigator Site | Kayseri | |
Turkey | Novartis Investigator Site | Kozlu / Zonguldak | |
Turkey | Novartis Investigator Site | Malatya | |
Turkey | Novartis Investigator Site | Manisa | |
Turkey | Novartis Investigator Site | Mecidiyekoy/Istanbul | |
Turkey | Novartis Investigator Site | Yenisehir/Izmir | |
United States | Novartis Investigator Site | Asbury Park | New Jersey |
United States | Novartis Investigative Site | Atlanta | Georgia |
United States | Novartis Investigator Site | Bethlehem | Pennsylvania |
United States | Novartis Investigator Site | Birmingham | Alabama |
United States | Novartis Investigator Site | Boys Town | Nebraska |
United States | Novartis Investigator Site | Brockton | Massachusetts |
United States | Novartis Investigator Site | Clarkston | Michigan |
United States | Novartis Investigative Site | Clearwater | Florida |
United States | Novartis Investigator Site | Columbia | Maryland |
United States | Novartis Investigator Site | Conyers | Georgia |
United States | Novartis Investigative Site | Cumberland | Rhode Island |
United States | Novartis Investigator Site | Detroit | Michigan |
United States | Novartis Investigator Site | El Paso | Texas |
United States | Novartis Investigator Site | Fountain Valley | California |
United States | Novartis Investigator Site | Ft. Walton Beach | Florida |
United States | Novartis Investigator Site | Greenville | South Carolina |
United States | Novartis Investigative Site | Hartford | Connecticut |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Iowa City | Iowa |
United States | Novartis Investigative Site | Kansas City | Kansas |
United States | Novartis Investigator Site | Knoxville | Tennessee |
United States | Novartis Investigator Site | Lafayette | Louisiana |
United States | Novartis Investigative Site | Las Vegas | Nevada |
United States | Novartis Investigator Site | Lebanon | New Hampshire |
United States | Novartis Investigative Site | Lenexa | Kansas |
United States | Novartis Investigator Site | Long Beach | California |
United States | Novartis Investigative Site | Los Angeles | California |
United States | Novartis Investigative Site | Medford | Oregon |
United States | Novartis Investigator Site | Metaire | Louisiana |
United States | Novartis Investigative Site | Miami | Florida |
United States | Novartis Investigative Site | Miami | Florida |
United States | Novartis Investigator Site | Missoula | Montana |
United States | Novartis Investigator Site | Mobile | Alabama |
United States | Novartis Investigator Site | Mooresville | North Carolina |
United States | Novartis Investigative Site | Naranja | Florida |
United States | Novartis Investigator Site | National City | California |
United States | Novartis Investigative Center | New Braunfels | Texas |
United States | Novartis Investigator Site | New Orleans | Louisiana |
United States | Novartis Investigator Site | Newport News | Virginia |
United States | Novartis Investigative Site | Normal | Illinois |
United States | Novartis Investigative Site | Omaha | Nebraska |
United States | Novartis Investigative site | Omaha | Nebraska |
United States | Novartis Investigator Site | Palmdale | California |
United States | Novartis Investigator Site | Pensacola | Florida |
United States | Novartis Investigator Site | Pine Bluff | Arkansas |
United States | Novartis Investigative Site | Richmond | Virginia |
United States | Novartis Investigator Site | Richmond | Virginia |
United States | Novartis Investigative Site | Rochester | New York |
United States | Novartis Investigator Site | Sarasota | Florida |
United States | Novartis Investigative Site | Scottsdale | Arizona |
United States | Novartis Investigator Site | Slidell | Louisiana |
United States | Novartis Investigative Site | Spartanburg | South Carolina |
United States | Novartis Investigative Site | St Charles | Missouri |
United States | Novartis Investigative Site | Stockton | California |
United States | Novartis Investigator Site | Temecula | California |
United States | Novartis Investigative Site | Topeka | Kansas |
United States | Novartis Investigative Site | Tucson | Arizona |
United States | Novartis Investigative Site | Tucson | Arizona |
United States | Novartis Investigator Site | Tulsa | Oklahoma |
United States | Novartis Investigative Site | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Argentina, Australia, Colombia, Denmark, Germany, Guatemala, Mexico, Philippines, South Africa, Spain, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. | From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84) | No |
Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. | 24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. | From 5 minutes to 8 hours post-dose on Day 1 | No |
Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. | 24 hours post-dose on Day 2 | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. | From 5 minutes to 4 hours post-dose on Day 1 | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. | From 5 minutes to 4 hours post-dose at the end of treatment (Week 12) | No |
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