Efficacy and Safety of Different Doses of Indacaterol

Asthma Clinical Trial

Official title:

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079130
• Other study ID #: CQAB149B2357
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2010
• Last updated: July 22, 2011
• Start date: February 2010

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of asthma, and:

1. Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening

2. Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening =50 and =90% of predicted normal

3. An increase of =12% and =200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol

Exclusion Criteria:

• Smoking history >10 pack-years

• Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)

• Patients with seasonal allergy whose asthma is likely to deteriorate during the study period

• Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening

• Patients who have had an intubation for a severe asthma exacerbation

• Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 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 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

• Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Indacaterol
Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
• Salmeterol
50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
• Placebo to Indacaterol
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.
• Placebo to Salmeterol
Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).

Locations

Country	Name	City	State
United States	Novartis Investigator Site	Austin	Texas
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigator Site	Bellevue	Nebraska
United States	Novartis Investigator Site	Boise	Idaho
United States	Novartis Investigator Site	Boys Town	Nebraska
United States	Novartis Investigator Site	Cadiz	Ohio
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigator Site	Colorado Springs	Colorado
United States	Novartis Investigator Site	Columbia	Maryland
United States	Novartis Investigator Site	Columbia	Missouri
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigator Site	Dallas	Texas
United States	Novartis Investigator Site	Denver	Colorado
United States	Novartis Investigative site	Destin	Florida
United States	Novartis Investigator Site	El Paso	Texas
United States	Novartis Investigator Site	El Paso	Texas
United States	Novartis Investigator Site	Encinitas	California
United States	Novartis Investigator Site	Engelwood	Colorado
United States	Novartis Investigative Site	Erie	Pennsylvania
United States	Novartis Investigator Site	Georgetown	Texas
United States	Novartis Investigator Site	Glendale	Arizona
United States	Novartis Investigator Site	Huntington Beach	California
United States	Novartis Investigator Site	Lafayette	Louisiana
United States	Novartis Investigator Site	Lake Oswego	Oregon
United States	Novartis Investigator Site	Lakewood	Colorado
United States	Novartis Investigative Site	Lincoln	Rhode Island
United States	Novartis Investigator Site	Los Angeles	California
United States	Novartis Investigator Site	Los Angeles	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Maumee	Ohio
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Mission Viejo	California
United States	Novartis Investigative Site	Missoula	Montana
United States	Novartis Investigator Site	Normal	Illinois
United States	Novartis Investigative site	North Charleston	South Carolina
United States	Novartis Investigative Site	North Dartmouth	Massachusetts
United States	Novartis Investigator Site	North Richland Hills	Texas
United States	Novartis Investigative Site	Ocean	New Jersey
United States	Novartis Investigator Site	Oklahoma City	Oklahoma
United States	Novartis Investigator Site	Orange	California
United States	Novartis Investigator Site	Overland Park	Kansas
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Phoenixville	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Port Orange	Florida
United States	Novartis Investigator Site	Portland	Oregon
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigator Site	Rancho Mirage	California
United States	Novartis Investigator Site	Rolla	Missouri
United States	Novartis Investigator Site	Rolling Hills Estates	California
United States	Novartis Investigator Site	San Diego	California
United States	Novartis Investigator Site	San Diego	California
United States	Novartis Investigator Site	San Jose	California
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigator Site	Scottsdale	Arizona
United States	Novartis Investigator Site	Seattle	Washington
United States	Novartis Investigative Site	Skillman	New Jersey
United States	Novartis Investigative Site	Springfield	Illinois
United States	Novartis Investigator Site	St. Louis	Missouri
United States	Novartis Investigative Site	Stamford	Connecticut
United States	Novartis Investigator Site	Stockton	California
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Upland	Pennsylvania
United States	Novartis Investigator Site	Waco	Texas
United States	Novartis Investigator Site	Warrensburg	Missouri
United States	Novartis Investigative Site	Waterbury	Connecticut
United States	Novartis Investigative Site	Wheaton	Maryland
United States	Novartis Investigative Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment	Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.	Day 15 (after 2 weeks of treatment)	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment	Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.	Day 2 (after 1 day of treatment)	No