Efficacy of Indacaterol 150 µg Versus Formoterol

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A 12-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Parallel-group Study to Assess the Efficacy of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 μg b.i.d.) as an Active Control

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01377428
• Other study ID #: CQAB149BDE03
• Status: Withdrawn
• Phase: Phase 4
• First received: June 17, 2011
• Last updated: April 19, 2017
• Start date: September 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).

Patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. Patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

• Post-bronchodilator FEV1 <80% and =40% of the predicted normal value

• Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

• Smoking history of at least 10 pack-years

Exclusion Criteria:

• Patients who have had 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 may apply

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol
Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)
• Formoterol
Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-h post-dose trough forced expiratory volume in 1 second (FEV1)		After 84 days of treatment
Secondary	24-h post-dose trough inspiratory capacity (IC)		After 84 days of treatment