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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615459
• Other study ID #: CQAB149B2331
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2008
• Last updated: July 22, 2011
• Start date: February 2008
• Est. completion date: December 2008

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilGermany: Federal Institute for Drugs and Medical DevicesNetherlands: Medicines Evaluation Board (MEB)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSouth Africa: Department of HealthSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover 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:
• Indacaterol
Indacaterol 150 µg or 300 µg, delivered via SDDPI
• Tiotropium
Tiotropium 18 µg once daily delivered via inhalation device
• Placebo
Placebo to indacaterol (150 or 300 µg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)

Locations

Country	Name	City	State
Australia	Novartis Investigative site	Camperdown
Germany	Novartis Investigator Site	Gauting
Germany	Novartis Investigator Site	Grosshansdorf
Germany	Novartis Investigator Site	Mainz
Germany	Novartis Investigator site	Marburg
Germany	Novartis Investigator Site	Wiesbaden
Netherlands	Novartis Investigator Site	Almelo
Netherlands	Novartis Investigator Site	Breda
Netherlands	Novartis Investigator Site	Eindhoven
Netherlands	Novartis Investigator Site	Harderwijk
Netherlands	Novartis Investigator Site	Helmond
New Zealand	Novartis Investigator Site	Wellington
Poland	Novartis Investigator Site	Katowice
Poland	Novartis Investigator Site	Warsaw
South Africa	Novartis Investigator Site	Durban
Spain	Novartis Investigative site	Alicante
Spain	Novartis Investigative Site	Cacenes
Spain	Novartis Investigator Site	La Coruna
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigator Site	Orense

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Australia,  Germany,  Netherlands,  New Zealand,  Poland,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.	23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period	No
Secondary	Peak FEV1 During 4 Hours Post Morning Dose on Day 1	FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.	Day 1 (from 0 to 4 hours post morning dose)	No