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)

NCT00636961 | Completed Phase 2 Results

• 1 other identifier: CQAB149B2318
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Indacaterol Maleate, Exercise testing

Outcome Measures

Primary Outcomes (1)

• Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14

  Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.

  Day 14

Secondary Outcomes (4)

• Static Inspiratory Capacity (IC) at Day 14

  Day 14

• Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14

  Day 14

• Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14

  Day 14

• Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14

  Day 1, Day 14

Study Arms (2)

Sequence 1: Indacaterol 300μg followed by Placebo

EXPERIMENTAL

In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.

Drug: Indacaterol 300μg; Drug: Placebo

Sequence 2 : Placebo followed by Indacaterol 300μg

EXPERIMENTAL

In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.

Drug: Indacaterol 300μg; Drug: Placebo

Interventions

Indacaterol 300μg DRUG

300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device

Also known as: Arcapta

Sequence 1: Indacaterol 300μg followed by Placebo; Sequence 2 : Placebo followed by Indacaterol 300μg

Placebo DRUG

Matching placebo devices and hard gelatin capsules

Sequence 1: Indacaterol 300μg followed by Placebo; Sequence 2 : Placebo followed by Indacaterol 300μg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (3)

Novartis Investigator Site

Berlin, Germany

Location

Novartis Investigator Site

Mönchengladbach, Germany

Location

Novartis Investigator Site

Wiesbaden, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis investigator site

  PRINCIPAL INVESTIGATOR

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: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 30, 2011
• Results First Posted: August 30, 2011

Record last verified: 2011-07

Locations

DE (3)