COPDPhase 4NCT01543828

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

A Phase 4 study testing indacaterol in people with COPD, run by Novartis Pharmaceuticals at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: indacaterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 6 sitesUnited States
Study dates: Jan 2012to Mar 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Novartis Investigative Site
Charlotte, North Carolina, 28207
Novartis Investigative Site
Columbus, Ohio, 43213
Novartis Investigative Site
Fullerton, California, 92835
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigative Site
Saint Charles, Missouri, 63301
Novartis Investigative Site
Tacoma, Washington, 98405

Other trials in United States

About this study

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

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.

Conditions: COPD
Being tested: indacaterol, placebo
Keywords: COPD, Indacatarol, placebo, crossover, patient perception
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

indacaterolDrug
delivered via single-dose dry-powder inhaler
placeboDrug
delivered via single-dose dry-powder inhaler

Study groups in NCT01543828
Study group	Role	What they receive
indacaterol then placebo	Experimental	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. Receives: Drug: indacaterol
placebo then indacaterol	Placebo comparator	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. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Mar 2012

First posted5 Mar 2012 (estimated)
Study startJan 2012
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01543828
Sponsor's protocol ID: CQAB149BUS01
Status last verified: May 2013
First submitted: 28 Feb 2012
Last updated: 10 May 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01543828
Acronym / sponsor ID: CQAB149BUS01
Conditions: COPD
Keywords: COPD, Indacatarol, placebo, crossover, patient perception
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 5 Mar 2012 (estimated)
Results: Posted 3 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
indacaterol then placebo	Experimental	Drug: indacaterolIn 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.
placebo then indacaterol	Placebo comparator	Drug: placeboIn 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
indacateroldelivered via single-dose dry-powder inhaler	Drug	indacaterol then placebo
placebodelivered via single-dose dry-powder inhaler	Drug	placebo then indacaterol

Primary outcome

Time (in Minutes) to Patient's Perception of Onset of Effect
Time frame: 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?"

Results and safety

Results posted to the registry on 3 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Indacaterol Then Placebo	20	20
Placebo Then Indacaterol	20	20

Primary outcome: Time (in Minutes) to Patient's Perception of Onset of Effect

Time frame: 5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2. Mean (Standard Deviation). Unit: Minutes

Measure	indacaterol_treatment 1 n = 20	indacaterol_treatment 2 n = 19	placebo_treatment 1 n = 20	placebo_treatment 2 n = 20
Value	25.13 (27.726)	26.05 (28.787)	21.88 (25.928)	25.88 (27.449)

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

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol	0 of 40 (0%)	2 of 40 (5%)	Not reported
Placebo	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing indacaterol in people with COPD, run by Novartis Pharmaceuticals at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time (in Minutes) to Patient's Perception of Onset of Effect (time frame: 5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01543828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.