Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma

Asthma Clinical Trial

— QAB149  

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Five Different Doses of Inhaled Indacaterol (QAB149) Delivered Via the Single Dose Dry Powder Inhaler (SDDPI) in Patients With Persistent Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959412
• Other study ID #: CQVA149A2210
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2013
• Last updated: April 20, 2015
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Asthma for at least 6 months, using inhaled corticosteroid for at least one month, foreced breath test less than below the normal value of the general population, -show an immediate improvement in breathing when given albuterol

Exclusion Criteria:

• patients who have smoked in the past 6 months or are currently smoking, including those who smoked more than a pack of cigarettes a day for at least 10 years, -patients who have a history of life-threatening asthma, -patients who have had an astham attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or ER visit, -patients who have had a respiratory tract infection or worsening asthma between screening or run-in periods, patients requring use of other asthma-related drugs during the trial, other protocol-defined inclusion/exclusion may apply

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Indacaterol 27.5 mcg
indacaterol 27.5 mcg twice daily inhaled once via inhaler
• Indacaterol 37.5
Indacaterol 37.5 mcg once daily, inhaled once via inhaler
• Indacaterol 55 mcg
Indacaterol 55 mcg once daily, inhaled once via inhaler
• Indacaterol 75 mcg
Indacaterol 75 mcg once daily, inhaled once via inhaler
• Indacaterol 150 mcg
Indacaterol 150 mcg once daily, inhaled once via inhaler
• Placebo
Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Centennial	Colorado
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	El Paso	Texas
United States	Novartis Investigative Site	Huntington Beach	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Mission Viejo	California
United States	Novartis Investigative Site	North Dartmouth	Massachusetts
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Skillman	New Jersey
United States	Novartis Investigative Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Period Baseline in FEV1 (L) AUC(0-24h)	Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.	Day 1 (24 hours)	No
Secondary	Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)	Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 12 hours post-dose period.	Day 1 (12 hours)	No
Secondary	Change From Period Baseline in Peak FEV1 (L)	Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points.	Day 1 (24 hours)	No
Secondary	Change From Period Baseline in Trough FEV1 (L)	Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements at different time points.	Day 1 (24 hours)	No
Secondary	Change From Period Baseline in FVC (L) AUC (0-24h)	Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.	Day 1 (24 hours)	No