Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT00545311
Safety and Tolerability of Multiple Inhaled NVA237 Doses in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 1 study testing NVA237 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 4 sites in 2 countries.
Trial summary
This study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of the NVA237 in mild and moderate COPD patients . Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- NVA237
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2007to Oct 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female patients aged from 40-75 years of age with mild to moderate COPD.
- Diagnosis of mild/moderate COPD, according to the GOLD guidelines.
- Bronchodilatory response to ipratropium at screening
- Current or ex-smokers with a smoking history of >10 pack-years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
- Female patients must have been surgically sterilized at least 6 months prior to screening or: Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
- Lab and post-bronchodilator values within a certain range.
- Body mass index (BMI) must be within the range of 18 to 32 kg/m2.
Who cannot join
- Any significant medical condition that in the opinion of the Investigator may compromise patient safety, patient compliance, interfere with evaluations, or preclude completion of the trial.
- Any medical condition that may make spirometry unsafe
- History of glaucoma, symptomatic prostatism or urinary retention.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations and for any other limitation of participation based on local regulations. Previous participation in a study with either the investigational or comparator drugs does not exclude a patient from participation in this study.
- Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- Significant illness (other than respiratory illness) within the two weeks prior to dosing.
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- Clinically significant ECG abnormalities indicative of an unstable underlying cardiac problem, e.g. recent myocardial infarction, 2nd/3rd degree heart block, or a family history grandparents, parents and siblings of a prolonged QT-interval syndrome.
- History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
- History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- Patients who are unable to demonstrate appropriate use of the Concept 1 device at screening
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Novartis investigative site
Berlin
Novartis investigative site
Mönchengladbach
Novartis Investigative Site
Munich
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Inhaled NVA237 Doses at Four Dose Levels in COPD Patients
This study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of the NVA237 in mild and moderate COPD patients .
- Being tested
- NVA237, Placebo
- Keywords
- multiple inhaled, NVA237, COPD
- 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.
NVA237Drug
NVA237Drug
NVA237Drug
NVA237Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NVA237 Receives: Drug: NVA237 |
| 2 | Experimental | NVA237 Receives: Drug: NVA237 |
| 3 | Experimental | NVA237 Receives: Drug: NVA237 |
| 4 | Experimental | NVA237 Receives: Drug: NVA237 |
| 5 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of NVA237 following single and repeated once-daily inhaled NVA237 doses
Secondary outcomes (1)
-Pharmacodynamics (PD) and PK/PD relationships of NVA237 following single and repeated once-daily inhaled NVA237 doses -Safety and tolerability of NVA237 following single and repeated once-daily inhaled NVA237 doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startJul 2007
- Study completionOct 2007
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.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545311
- Sponsor's protocol ID
- CNVA237A2103
- Status last verified
- Dec 2007
- First submitted
- 15 Oct 2007
- Last updated
- 8 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Inhaled NVA237 Doses at Four Dose Levels in COPD Patients
- ClinicalTrials.gov ID
- NCT00545311
- Acronym / sponsor ID
- CNVA237A2103
- Keywords
- multiple inhaled, NVA237, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 17 Oct 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 evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of the NVA237 in mild and moderate COPD patients .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NVA237NVA237 |
| 2 | Experimental | Drug: NVA237NVA237 |
| 3 | Experimental | Drug: NVA237NVA237 |
| 4 | Experimental | Drug: NVA237NVA237 |
| 5 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and/or female patients aged from 40-75 years of age with mild to moderate COPD.
- Diagnosis of mild/moderate COPD, according to the GOLD guidelines.
- Bronchodilatory response to ipratropium at screening
- Current or ex-smokers with a smoking history of >10 pack-years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
- Female patients must have been surgically sterilized at least 6 months prior to screening or: Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
Key exclusion criteria (13 listed)
- Any significant medical condition that in the opinion of the Investigator may compromise patient safety, patient compliance, interfere with evaluations, or preclude completion of the trial.
- Any medical condition that may make spirometry unsafe
- History of glaucoma, symptomatic prostatism or urinary retention.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations and for any other limitation of participation based on local regulations. Previous participation in a study with either the investigational or comparator drugs does not exclude a patient from participation in this study.
- Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
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 |
|---|---|---|
| NVA237 | Drug | 1 |
| NVA237 | Drug | 2 |
| NVA237 | Drug | 3 |
| NVA237 | Drug | 4 |
| Placebo | Drug | 5 |
Primary outcome
Pharmacokinetics (PK) of NVA237 following single and repeated once-daily inhaled NVA237 doses
1 secondary outcome
-Pharmacodynamics (PD) and PK/PD relationships of NVA237 following single and repeated once-daily inhaled NVA237 doses -Safety and tolerability of NVA237 following single and repeated once-daily inhaled NVA237 doses
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 8 Jan 2008.
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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
Investigator site
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NVA237 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 4 sites in 2 countries.
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 7 inclusion and 13 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 8 Jan 2008. 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 Germany, Denmark. 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?
Pharmacokinetics (PK) of NVA237 following single and repeated once-daily inhaled NVA237 doses. 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 8 Jan 2008.