Clinical trial NCT01959412: Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: wheezing, short of breath, laba, inhaler
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Period Baseline in FEV1 (L) AUC(0-24h)
timeFrame: Day 1 (24 hours)
Secondary outcomes:
measure: Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)
timeFrame: Day 1 (12 hours)
measure: Change From Period Baseline in Peak FEV1 (L)
timeFrame: Day 1 (24 hours)
measure: Change From Period Baseline in Trough FEV1 (L)
timeFrame: Day 1 (24 hours)
measure: Change From Period Baseline in FVC (L) AUC (0-24h)
timeFrame: Day 1 (24 hours)
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Mission Viejo
country: United States
facility: Novartis Investigative Site
state: California
city: Centennial
country: United States
facility: Novartis Investigative Site
state: Colorado
city: North Dartmouth
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Skillman
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: