Clinical trial NCT00636961: An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
Official title: An Exploratory, Double Blind, Randomized, Placebo-controlled, 2-way Cross-over Study to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Indacaterol Maleate, Exercise testing
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-17
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients


Eligibility criteria: Inclusion Criteria:

* Male and female subjects,
* 40 to 80 years of age,
* with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC \< 70% who have signed an informed consent form (ICF) prior to the initiation of any study-related procedure (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol)
* Subjects who demonstrate a plethysmographic functional residual capacity \>120% predicted normal

Exclusion Criteria:

* No COPD exacerbations within 6 weeks prior to dosing,
* no concomitant lung disease such as asthma,
* no requirement for long term oxygen treatment or history of lung reduction surgery.
* No medical conditions that would interfere with the performance of spirometry or clinical exercise testing.
* Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14
timeFrame: Day 14
Secondary outcomes:
measure: Static Inspiratory Capacity (IC) at Day 14
timeFrame: Day 14
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14
timeFrame: Day 14
measure: Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14
timeFrame: Day 14
measure: Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14
timeFrame: Day 1, Day 14
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Mönchengladbach
country: Germany
facility: Novartis Investigator Site
city: Wiesbaden
country: Germany
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: