Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01543828
• Collaborator: (none)
• Enrollment: 40
• Locations: 6
• Arms: 2
• Duration (Months): 2
• Patients Per Site: 6.7
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in moderate-severe COPD patients with breathing symptoms to assess time to patient's perception of onset of effect.

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: indacaterol; Drug: placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase IV, Randomized, Double-blind, Placebo-controlled, Multicenter, Exploratory, Single-dose Crossover Study With Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: indacaterol then placebo In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.	Drug: indacaterol; delivered via single-dose dry-powder inhaler
Placebo Comparator: placebo then indacaterol In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.	Drug: placebo; delivered via single-dose dry-powder inhaler

Outcome Measures

Primary Outcome Measures

1. Time (in Minutes) to Patient's Perception of Onset of Effect [5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2]

   Defined as the first time point that the patient responds "yes" to the following self-administered question: "I feel that the drug is working in improving my breathing?"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening

• Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD]

Guidelines, 2008) and:

• Smoking history of at least 10 pack-years

• Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 70% and ≥ 40% of the predicted normal value

• Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

• Breathing symptoms that interfere with daily activities

Exclusion Criteria:

• Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening

• Patients who have had a respiratory tract infection within 6 weeks prior to screening

• Patients who require oxygen therapy for chronic hypoxemia, are receiving bronchodilators or other medications for COPD that are dosed once daily, are unable to follow instruction on rescue albuterol use during the study, or are at risk deterioration of COPD with study procedures. Patients with concomitant pulmonary disease

• Patients with a history of asthma

• Patients with uncontrolled diabetes mellitus

• Any patient with lung cancer or a history of lung cancer

• Patients with a history of certain cardiovascular co-morbid conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Fullerton	California	United States	92835
2	Novartis Investigative Site	St. Charles	Missouri	United States	63301
3	Novartis Investigative Site	Charlotte	North Carolina	United States	28207
4	Novartis Investigative Site	Raleigh	North Carolina	United States	27607
5	Novartis Investigative Site	Columbus	Ohio	United States	43213
6	Novartis Investigative Site	Tacoma	Washington	United States	98405

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01543828
• Other Study ID Numbers: CQAB149BUS01
• First Posted: Mar 5, 2012
• Last Update Posted: May 10, 2013
• Last Verified: May 1, 2013

• Keywords provided by Novartis Pharmaceuticals: COPD; Indacatarol; placebo; crossover; patient perception
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Arm/Group Title	Indacaterol Then Placebo	Placebo Then Indacaterol
Arm/Group Description	In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.	In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
Period Title: Treatment 1
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0
Period Title: Treatment 1
STARTED	20	19
COMPLETED	19	19
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Indacaterol Then Placebo	Placebo Then Indacaterol	Total
Arm/Group Description	In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.	In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.2 (10.29)	60.8 (6.90)	61.5 (8.68)
Sex: Female, Male (Count of Participants)
Female	9 45%	4 20%	13 32.5%
Male	11 55%	16 80%	27 67.5%

Outcome Measures

1. Primary Outcome

Title	Time (in Minutes) to Patient's Perception of Onset of Effect
Description	Defined as the first time point that the patient responds "yes" to the following self-administered question: "I feel that the drug is working in improving my breathing?"
Time Frame	5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set included all participants who received one dose of study drug.

Arm/Group Title	indacaterol_treatment 1	indacaterol_treatment 2	placebo_treatment 1	placebo_treatment 2
Arm/Group Description	In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI). Albuterol was available for use as rescue medication.	In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.	In treatment 1, participants received placebo one dose delivered via SDDPI. Albuterol was available for use as rescue medication.	In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
Measure Participants	20	19	20	20
Mean (Standard Deviation) [Minutes]	25.13 (27.726)	26.05 (28.787)	21.88 (25.928)	25.88 (27.449)

Adverse Events

Arm/Group Title	Indacaterol		Placebo
Arm/Group Description	Participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI).		Participants received placebo one dose delivered via SDDPI.
All Cause Mortality
	Indacaterol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Indacaterol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Indacaterol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/40 (5%)		0/40 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	2/40 (5%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.