Efficacy of Indacaterol 150 µg Versus Formoterol

Phase 4

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Indacaterol; Drug: Formoterol

• Registration Number: NCT01377428
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-21
• Study Start: 2011-09
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-05
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indacaterol	Indacaterol	Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)
Formoterol	Formoterol	Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)

Primary Outcome Measures

Name	Time	Method
24-h post-dose trough forced expiratory volume in 1 second (FEV1)	After 84 days of treatment

Secondary Outcome Measures

Name	Time	Method
24-h post-dose trough inspiratory capacity (IC)	After 84 days of treatment