Efficacy of Indacaterol 150 µg Versus Formoterol

NCT01377428 | Withdrawn Phase 4

• 1 other identifier: CQAB149BDE03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Indacaterol; Formoterol

Outcome Measures

Primary Outcomes (1)

• 24-h post-dose trough forced expiratory volume in 1 second (FEV1)

  After 84 days of treatment

Secondary Outcomes (1)

• 24-h post-dose trough inspiratory capacity (IC)

  After 84 days of treatment

Study Arms (2)

Indacaterol

EXPERIMENTAL

Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)

Drug: Indacaterol

Formoterol

ACTIVE COMPARATOR

Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)

Drug: Formoterol

Interventions

Indacaterol DRUG

Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)

Indacaterol

Formoterol DRUG

Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)

Formoterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 21, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 20, 2017

Record last verified: 2012-05