Chronic Obstructive Pulmonary DiseasePhase 1NCT00532350
Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
A Phase 1 study testing QAT370 and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 3 sites in Germany.
Trial summary
This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- QAT370 and Tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2007to Jan 2008
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 40 and 80 years of age with controlled COPD.
- Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment.
- Body mass index (BMI) must be within the range of 18 to 32 kg/m2
Who cannot join
- Participation in any interventional clinical investigation with 4 weeks of study start
- Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
- Past medical personal or close family history of clinically significant ECG abnormalities
- Any medical condition that may interfere with exercise testing or that may make spirometry unsafe
- A known hypersensitivity to the drug.
- History of immunocompromise, including a positive HIV test result.
- History of drug or alcohol abuse within 12 months of study start
- Any condition that may compromise patient safety
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Novartis investigative site
Berlin
Novartis Investigative site
Mannheim
Novartis Investigative site
Wiesbaden
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Efficacious Dose of QAT370 Compared to Open-label Tiotropium Bromide Following Once Daily Dosing for 7 Days in COPD Patients
This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- QAT370, Placebo, Tiotropium
- Keywords
- COPD, pharmacokinetics, plethysmography, cycle ergometry, exercise testing, spirometry
- 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.
QAT370Drug
PlaceboDrug
TiotropiumDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | QAT370 Receives: Drug: QAT370 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 3 | Active comparator | Tiotropium Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second
Measured: Days 1 and 7
Secondary outcomes (1)
Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.
Measured: Days 1 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startJul 2007
- Study completionJan 2008
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigative site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532350
- Sponsor's protocol ID
- CQAT370A2103
- Status last verified
- Sep 2010
- First submitted
- 19 Sep 2007
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Efficacious Dose of QAT370 Compared to Open-label Tiotropium Bromide Following Once Daily Dosing for 7 Days in COPD Patients
- ClinicalTrials.gov ID
- NCT00532350
- Acronym / sponsor ID
- CQAT370A2103
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, pharmacokinetics, plethysmography, cycle ergometry, exercise testing, spirometry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Study completion
- Jan 2008 (actual)
- First posted
- 20 Sep 2007 (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 safety and tolerability of QAT370 compared to tiotropium in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: QAT370QAT370 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
| 3 | Active comparator | Drug: TiotropiumTiotropium |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 40 and 80 years of age with controlled COPD.
- Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment.
- Body mass index (BMI) must be within the range of 18 to 32 kg/m2
Key exclusion criteria (8 listed)
- Participation in any interventional clinical investigation with 4 weeks of study start
- Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
- Past medical personal or close family history of clinically significant ECG abnormalities
- Any medical condition that may interfere with exercise testing or that may make spirometry unsafe
- A known hypersensitivity to the drug.
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 |
|---|---|---|
| QAT370 | Drug | 1 |
| Placebo | Drug | 2 |
| Tiotropium | Drug | 3 |
Primary outcome
Forced expiratory volume in 1 second
Time frame: Days 1 and 7
1 secondary outcome
Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.
Time frame: Days 1 and 7
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 CQAT370A2103 can be found on the Novartis Clinical Trial Results 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 principal investigator
Investigative site
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QAT370 and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 3 sites in Germany.
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 3 sites in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Forced expiratory volume in 1 second (time frame: Days 1 and 7). 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.