Clinical trial NCT00615459: A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
Official title: A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease, indacaterol, tiotropium, placebo controlled
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 169
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria:

* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* Co-operative out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:

  1. Smoking history of at least 10 pack years (current or previous smokers)
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥30% of the predicted normal value.
  3. Post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%

Exclusion Criteria:

* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
* Patients requiring long-term oxygen therapy for chronic hypoxemia
* Patients who have had a respiratory tract infection within 6 weeks prior to Visit
* 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
* Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at Visit 1 or randomization is prolonged
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
* Patients unable to successfully use a dry powder inhaler device, MDI or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: 24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment
timeFrame: 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period
Secondary outcomes:
measure: Peak FEV1 During 4 Hours Post Morning Dose on Day 1
timeFrame: Day 1 (from 0 to 4 hours post morning dose)
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Novartis Investigative site
city: Gauting
country: Germany
facility: Novartis Investigator Site
city: Grosshansdorf
country: Germany
facility: Novartis Investigator Site
city: Mainz
country: Germany
facility: Novartis Investigator Site
city: Marburg
country: Germany
facility: Novartis Investigator site
city: Wiesbaden
country: Germany
facility: Novartis Investigator Site
city: Almelo
country: Netherlands
facility: Novartis Investigator Site
city: Breda
country: Netherlands
facility: Novartis Investigator Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigator Site
city: Harderwijk
country: Netherlands
facility: Novartis Investigator Site
city: Helmond
country: Netherlands
facility: Novartis Investigator Site
city: Wellington
country: New Zealand
facility: Novartis Investigator Site
city: Katowice
country: Poland
facility: Novartis Investigator Site
city: Warsaw
country: Poland
facility: Novartis Investigator Site
city: Durban
country: South Africa
facility: Novartis Investigator Site
city: Alicante
country: Spain
facility: Novartis Investigative site
city: Cacenes
country: Spain
facility: Novartis Investigative Site
city: La Coruna
country: Spain
facility: Novartis Investigator Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Orense
country: Spain
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma
role: STUDY_CHAIR
References:
citation: Vogelmeier C, Ramos-Barbon D, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INTIME study investigators (INdacaterol & TIotropium: Measuring Efficacy). Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium. Respir Res. 2010 Oct 5;11(1):135. doi: 10.1186/1465-9921-11-135.