Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

NCT01156844 | Completed Phase 2 Results

• 2 other identifiers: CQAB149B22232010-018481-22
• Study Type: interventional
• Target: 191
• Locations: 6 countries
• Sites: 30

Brief Summary

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

Conditions

Persistent Asthma

Keywords

Indacaterol; Asthma; Bronchodilation; Beta-agonist

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment

  Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.

  Baseline to week 2

• Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment

  Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.

  Baseline, 0-24 hours post dose week 2

• Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment

  Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.

  Baseline, 0 to 48 hours post dose week 2

Secondary Outcomes (1)

• Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment

  Baseline, 0 to 12 hours post dose week 2

Study Arms (4)

Indacaterol 37.5 µg (twice a day)

EXPERIMENTAL

Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol

Indacaterol 75 µg (once a day)

EXPERIMENTAL

Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol; Drug: Placebo to Indacaterol

Indacaterol 150 µg (every other day)

EXPERIMENTAL

Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol; Drug: Placebo to Indacaterol

Placebo

PLACEBO COMPARATOR

Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Placebo to Indacaterol

Interventions

Indacaterol DRUG

Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.

Indacaterol 150 µg (every other day); Indacaterol 37.5 µg (twice a day); Indacaterol 75 µg (once a day)

Placebo to Indacaterol DRUG

Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.

Indacaterol 150 µg (every other day); Indacaterol 75 µg (once a day); Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with a diagnosis of asthma and:
• Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
• FEV1 ≥50% and ≤90% of predicted normal at screening
• An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

You may not qualify if:

• Smoking history of ≥ 10 years
• Patients with a diagnosis of COPD
• Patients who have been previously intubated for a severe asthma exacerbation/ attack
• Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
• Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
• Patients who have had a respiratory tract infection within 6 weeks prior to screening
• Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
• Patients with Type I or uncontrolled Type II diabetes mellitus

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (30)

Novartis Investigative Site

Anniston, Alabama, 36207, United States

Location

Novartis Investigative Site

Cypress, California, 90630, United States

Location

Novartis Investigative Site

Fresno, California, 93726, United States

Location

Novartis Investigative Site

San Diego, California, 92120, United States

Location

Novartis Investigative Site

Denver, Colorado, 80206, United States

Location

Novartis Investigative Site

Clearwater, Florida, 33756, United States

Location

Novartis Investigative Site

Miami, Florida, 33167, United States

Location

Novartis Investigative Site

Miami, Florida, 33175, United States

Location

Novartis Investigative Site

Sarasota, Florida, 34233, United States

Location

Novartis Investigative Site

Tampa, Florida, 33617, United States

Location

Novartis Investigative Site

Normal, Illinois, 61761, United States

Location

Novartis Investigative Site

Lafayette, Louisiana, 70503, United States

Location

Novartis Investigative Site

Las Vegas, Nevada, 89119, United States

Location

Novartis Investigative Site

Berlin, New Jersey, 08009, United States

Location

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Location

Novartis Investigator Site

Oklahoma City, Oklahoma, 73120, United States

Location

Novartis Investigative Site

Houston, Texas, 77070, United States

Location

Novartis Investigative Site

Plano, Texas, 75075, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78212, United States

Location

Novartis Investigative Site

Tacoma, Washington, 98405, United States

Location

Novartis Investigative Site

Tacoma, Washington, 98418, United States

Location

Novartis Investigative Site

Paris, France

Location

Novartis Investigative Site

Rennes, France

Location

Novartis Investigative Site

Wiesbaden, Germany

Location

Novartis Investigative Site

Amman, Jordan

Location

Novartis Investigative Site

Irbid, Jordan

Location

Novartis Investigative Site

Groningen, Netherlands

Location

Novartis Investigative Site

London, United Kingdom

Location

Novartis Investigative Site

Manchester, United Kingdom

Location

Novartis Investigative Site

Merthyr Tydfil, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 5, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Last Updated: August 17, 2011
• Results First Posted: August 17, 2011

Record last verified: 2011-07

Locations

US (21); JO (2); DE (1); FR (2); NL (1); GB (3)