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Bronchodilator

Indacaterol 75 µg for Chronic Obstructive Pulmonary Disease

Phase 3
Waitlist Available
Research Sponsored by Novartis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Secondary study objectives
Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment

Side effects data

From 2016 Phase 4 trial • 222 Patients • NCT02055352
9%
Influenza
9%
Nasopharyngitis
8%
Headache
7%
Dysphonia
6%
Urinary tract infection
6%
Arthralgia
5%
Back pain
2%
Chronic obstructive pulmonary disease
1%
Vascular insufficiency
1%
Venous thrombosis limb
1%
Peripheral arterial occlusive disease
1%
Acute myocardial infarction
1%
Cor pulmonale
1%
Nodal arrhythmia
1%
Pneumonia
1%
Hip fracture
1%
Hepatocellular carcinoma
1%
Acute pulmonary oedema
1%
Bradycardia
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluticasone / Salmeterol (B)
Budesonide / Indacaterol (A)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Indacaterol 75 µgExperimental Treatment1 Intervention
Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Group II: PlaceboPlacebo Group1 Intervention
Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indacaterol
FDA approved

Find a Location

Who is running the clinical trial?

NovartisLead Sponsor
1,636 Previous Clinical Trials
2,773,289 Total Patients Enrolled
Novartis PharmaceuticalsStudy DirectorNovartis Pharmaceuticals
2,216 Previous Clinical Trials
4,111,036 Total Patients Enrolled
~20 spots leftby Nov 2025
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