Chronic Obstructive Pulmonary Disease (COPD)Phase 4INITIATENCT01715311
Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control
A Phase 4 study testing Indacaterol and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals.
Trial summary
This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have not received maintenance COPD medication for at least 12 months prior to entry (described hereafter as "maintenance naïve", see… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Indacaterol and Tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Sep 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 with stable Chronic Obstructive Pulmonary Disease (COPD) Groups A or B according to GOLD 2011.
- Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥50% and <80% of the predicted normal, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7
- Patients with no record of receipt of maintenance medication for COPD.
- Patients with a mMRC dyspnea score ≥1 at Visit 2.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
Who cannot join
- Patients who have not achieved acceptable spirometry results at run-in, in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability.
- Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12 months prior to Visit 1.
- Patients who have had a respiratory tract infection.
- Patients requiring long-term oxygen therapy (>12 hours a day) on a daily basis.
- Patients with a) any history of asthma, or b) onset of respiratory symptoms prior to age 40 years.
- Patients with allergic rhinitis who use a H1-antagonist or intra-nasal corticosteroids intermittently. Treatment with a stable dose is permitted.
- Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disorder, pulmonary hypertension) or active pulmonary tuberculosis
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: A Randomized, Double-blind Placebo-controlled Study to Compare the Efficacy of Indacaterol With That of Placebo in Patients With COPD Who Have Not Previously Received Maintenance COPD Medication, Using Blinded Tiotropium as Active Control
This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have not received maintenance COPD medication for at least 12 months prior to entry (described hereafter as "maintenance naïve", see inclusion criteria).
Read the detailed description
The purpose is to provide efficacy data comparing the long-acting beta-2 agonist, indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to GOLD 2011 Groups A and B.
- Being tested
- Indacaterol, Placebo to tiotropium, Tiotropium, Placebo to indacaterol
- Keywords
- COPD, Chronic obstructive pulmonary disease, indacaterol, tiotropium
- 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
Indacaterol once daily via single-dose dry powder inhaler
Placebo to tiotropiumDrug
Placebo to tiotropium capsules for inhalation once daily
TiotropiumDrug
Also called Tiotropium 18 mcg od via single-dose dry powder inhaler
Tiotropium capsules for inhalation once daily
Placebo to indacaterolDrug
Placebo to indacaterol capsules for inhalation once daily
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol | Experimental | Indacaterol once daily Receives: Drug: Indacaterol; Drug: Placebo to indacaterol |
| Placebo | Placebo comparator | Placebo for indacaterol and placebo for tiotropium once daily Receives: Drug: Placebo to tiotropium; Drug: Placebo to indacaterol |
| Tiotropium | Active comparator | Tiotropium Receives: Drug: Placebo to tiotropium; Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy comparison of indacaterol to placebo
Efficacy comparison of indacaterol to placebo (once daily treatment) by measuring Trough Forced Expiratory Volume in one second 24 hour postdose after 12 weeks of treatment.
Measured: 12 weeks
Secondary outcomes (4)
St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments
Effects comparison of indacaterol to placebo in terms of the patient-centric measurement St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.
Measured: 12 weeks
Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups
Comparison of indacaterol to tiotropium using Trough Forced Expiratory Volume in one second.
Measured: 12 weeks
St George's Respiratory Questionnaire for COPD total score comparison between treatments
Effects comparison of indacaterol to tiotropium in terms of St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.
Measured: 12 weeks
Adverse events and serious adverse events for all treatment groups
All adverse events will be reported
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Why it stopped: withdrawn prior to patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715311
- Sponsor's protocol ID
- CQAB149B2425
- Other IDs
- 2012-001536-59
- Acronym
- INITIATE
- Status last verified
- Feb 2013
- First submitted
- 24 Oct 2012
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled Study to Compare the Efficacy of Indacaterol With That of Placebo in Patients With COPD Who Have Not Previously Received Maintenance COPD Medication, Using Blinded Tiotropium as Active Control
- ClinicalTrials.gov ID
- NCT01715311
- Acronym / sponsor ID
- INITIATE / CQAB149B2425
- Keywords
- COPD, Chronic obstructive pulmonary disease, indacaterol, tiotropium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn prior to patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have not received maintenance COPD medication for at least 12 months prior to entry (described hereafter as "maintenance naïve", see inclusion criteria).
Detailed description
The purpose is to provide efficacy data comparing the long-acting beta-2 agonist, indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to GOLD 2011 Groups A and B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Indacaterol | Experimental | Drug: Indacaterol, Drug: Placebo to indacaterolIndacaterol once daily |
| Placebo | Placebo comparator | Drug: Placebo to tiotropium, Drug: Placebo to indacaterolPlacebo for indacaterol and placebo for tiotropium once daily |
| Tiotropium | Active comparator | Drug: Placebo to tiotropium, Drug: TiotropiumTiotropium |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with stable Chronic Obstructive Pulmonary Disease (COPD) Groups A or B according to GOLD 2011.
- Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥50% and <80% of the predicted normal, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7
- Patients with no record of receipt of maintenance medication for COPD.
- Patients with a mMRC dyspnea score ≥1 at Visit 2.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
Key exclusion criteria (8 listed)
- Patients who have not achieved acceptable spirometry results at run-in, in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability.
- Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12 months prior to Visit 1.
- Patients who have had a respiratory tract infection.
- Patients requiring long-term oxygen therapy (>12 hours a day) on a daily basis.
- Patients with a) any history of asthma, or b) onset of respiratory symptoms prior to age 40 years.
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 |
|---|---|---|
| IndacaterolIndacaterol once daily via single-dose dry powder inhaler | Drug | Indacaterol |
| Placebo to tiotropiumPlacebo to tiotropium capsules for inhalation once daily | Drug | Placebo, Tiotropium |
| TiotropiumAlso: Tiotropium 18 mcg od via single-dose dry powder inhalerTiotropium capsules for inhalation once daily | Drug | Tiotropium |
| Placebo to indacaterolPlacebo to indacaterol capsules for inhalation once daily | Drug | Indacaterol, Placebo |
Primary outcome
Efficacy comparison of indacaterol to placebo
Time frame: 12 weeks
Efficacy comparison of indacaterol to placebo (once daily treatment) by measuring Trough Forced Expiratory Volume in one second 24 hour postdose after 12 weeks of treatment.
4 secondary outcomes
St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments
Time frame: 12 weeks
Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups
Time frame: 12 weeks
St George's Respiratory Questionnaire for COPD total score comparison between treatments
Time frame: 12 weeks
Adverse events and serious adverse events for all treatment groups
Time frame: week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indacaterol and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals.
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 5 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: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy comparison of indacaterol to placebo (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2017.