Chronic Obstructive Pulmonary DiseasePhase 2NCT01068613
Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 2 study testing QAX028 and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 4 sites in United States.
Trial summary
This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- QAX028 and Tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2010to Aug 2010
- Phase
- Phase 2
- 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
- Diagnosis of COPD according to GOLD guidelines
- Post-bronchodilator 30%≤FEV1<80% of predicted normal and ost-bronchodilator FEV1/FVC <0.7
- Smoking history of at least 10 pack years
Who cannot join
- Requiring oxygen therapy on a daily basis
- Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing
- Lung reduction surgery
- Respiratory tract infection in the 6 weeks prior to screening
- Significant cardiac history
- History of asthma with onset of symptoms prior to age 40 years
- Active use of certain COPD medications, beta blockers
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Advanced Clinical Research Institute, 1211 W. La Palma Ave
Anaheim, California, CA
New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway
Knoxville, Tennessee, TN 37920
Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive
Normal, Illinois, IL61761
Spartanburg Medical Research, 485 Simuel Road
Spartanburg, South Carolina, SC 29303
About this study
Official title: A Randomized, Double-blind, Double-dummy, Three Period Incomplete Cross-over Study to Evaluate the Safety and Efficacy of Multiple Daily Doses of QAX028 as Compared to Tiotropium Bromide (Positive Control) and Placebo in COPD Patients
This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- QAX028, Tiotropium, Placebo
- Keywords
- COPD, Long acting muscarinic antagonist
- 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.
QAX028Drug
QAX028 60 mcg via inhalation device
QAX028Drug
QAX028 20 mcg via inhalation device
TiotropiumDrug
Tiotropium via inhalation device
PlaceboDrug
Placebo to QAX028 via inhalation device
| Study group | Role | What they receive |
|---|---|---|
| QAX028 high dose | Experimental | Not described Receives: Drug: QAX028 |
| QAX028 low dose | Experimental | Not described Receives: Drug: QAX028 |
| Tiotropium | Active comparator | Not described Receives: Drug: Tiotropium |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium
Measured: 7 days treatment
Secondary outcomes (5)
Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium
Measured: 7 days treatment
Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo
Measured: 7 days treatment
Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients
Measured: 7 days treatment
Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028
Measured: 7 days treatment
Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients
Measured: 7 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 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
- NCT01068613
- Sponsor's protocol ID
- CQAX028A2201
- Status last verified
- May 2012
- First submitted
- 12 Feb 2010
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Three Period Incomplete Cross-over Study to Evaluate the Safety and Efficacy of Multiple Daily Doses of QAX028 as Compared to Tiotropium Bromide (Positive Control) and Placebo in COPD Patients
- ClinicalTrials.gov ID
- NCT01068613
- Acronym / sponsor ID
- CQAX028A2201
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Long acting muscarinic antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 15 Feb 2010 (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 assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QAX028 high dose | Experimental | Drug: QAX028 |
| QAX028 low dose | Experimental | Drug: QAX028 |
| Tiotropium | Active comparator | Drug: Tiotropium |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD according to GOLD guidelines
- Post-bronchodilator 30%≤FEV1<80% of predicted normal and ost-bronchodilator FEV1/FVC <0.7
- Smoking history of at least 10 pack years
Key exclusion criteria (8 listed)
- Requiring oxygen therapy on a daily basis
- Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing
- Lung reduction surgery
- Respiratory tract infection in the 6 weeks prior to screening
- Significant cardiac history
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 |
|---|---|---|
| QAX028QAX028 60 mcg via inhalation device | Drug | QAX028 high dose |
| QAX028QAX028 20 mcg via inhalation device | Drug | QAX028 low dose |
| TiotropiumTiotropium via inhalation device | Drug | Tiotropium |
| PlaceboPlacebo to QAX028 via inhalation device | Drug | Placebo |
Primary outcome
Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium
Time frame: 7 days treatment
5 secondary outcomes
Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium
Time frame: 7 days treatment
Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo
Time frame: 7 days treatment
Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients
Time frame: 7 days treatment
Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028
Time frame: 7 days treatment
Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients
Time frame: 7 days treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for CQAX028A2201 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAX028 and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 4 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 3 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium (time frame: 7 days treatment). 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 19 Dec 2020.