AsthmaPhase 2NCT01516086
A 12-Week Study in Adult Subjects With Asthma
A Phase 2 study testing Fluticasone Propionate (FP) in people with Asthma, run by Dey at 1 site in United States.
Trial summary
This will be a multi-center, randomized, placebo controlled parallel-group study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects with Partly Controlled and Uncontrolled Asthma. Individual participation will be approximately 16 weeks, including 12 weeks of double-blind treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone Propionate (FP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Nov 2013
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A signed and dated written informed consent form prior to the conduct of any study procedures
- Males and females between ≥ 18 and ≤ 60 years old.
- Non-smoker for at least 1 year prior to Visit 1, with a smoking history of no more than 10 pack-years (e.g., 1 pack [20 cigarettes] per day for 10 years).
- 6.Ability to understand and comply with the protocol requirements (including completion of daily PEFR, PFT and ACQ), instructions and protocol-stated restrictions.
- 7.Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit. WOCBP include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP.
- WOCBP must agree to avoid becoming pregnant for the duration of the study by using adequate contraception at study entry and throughout the trial. Examples of adequate contraception include the following:
Show all 12Show fewer
- Norplant
- Medroxyprogesterone acetate injection
- Oral contraception
- Double-barrier method (e.g., condom and spermicide)
- Abstinence, with one of the above WOCBP will be advised to notify the Investigator of any changes in their pregnancy status or any change in contraceptive use.
- 8.Agreement by subject to abide by the study protocol and its restrictions.
Who cannot join
- Past or present disease, excluding asthma, which as judged by the investigator, may place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives These diseases include, but are not limited to cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, diabetes type I or uncontrolled diabetes, type II, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis, COPD, eosinophilic bronchitis or pulmonary fibrosis).
- An upper or lower respiratory tract infection within 4 weeks of Visit 1 and prior to Visit 2
- A history of hypersensitivity to the study drug or its components, including albuterol as rescue medication.
- History of illegal drug or alcohol abuse within the past 5 years.
- Pregnant or lactating women.
- Use of > 8 inhalations per day of SABA on any two consecutive days from screening to randomization (Visits 1 and 2).
- Use of an investigational drug or device within 30 days prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
CU Pharmaceutical Research
Rock Hill, South Carolina, 29732
About this study
Official title: A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects With Partly Controlled and Uncontrolled Asthma
This will be a multi-center, randomized, placebo controlled parallel-group study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects with Partly Controlled and Uncontrolled Asthma. Individual participation will be approximately 16 weeks, including 12 weeks of double-blind treatment.
Read the detailed description
The primary outcome measure is FEV1 (Forced Expiry Volume in 1 second) and the secondary outcome measure is Peak Expiratory Flow Rate (PEFR), Asthma Control Questionnaire (ACQ), Nighttime awakenings and rescue medication usage.
- Conditions
- Asthma
- Being tested
- Fluticasone Propionate (FP)
- Keywords
- Controlled, uncontrolled
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate (FP)Drug
Also called No other names applicable
FP Inhalation BID
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Propionate (FP) - arm 1 | Experimental | FP BID (twice daily) Receives: Drug: Fluticasone Propionate (FP) |
| Fluticasone propionate (FP) - arm 2 | Experimental | FP BID Receives: Drug: Fluticasone Propionate (FP) |
| Fluticasone Propionate (FP) - arm 3 | Experimental | FP BID Receives: Drug: Fluticasone Propionate (FP) |
| FLuticasone Propionate (FP) - Arm 4 | Experimental | FP BID Receives: Drug: Fluticasone Propionate (FP) |
| Fluticasone Propionate (FP) - Arm 5 | Experimental | FP BID Receives: Drug: Fluticasone Propionate (FP) |
| Placebo - Arm 6 | Placebo comparator | Placebo inhalation solution Receives: Drug: Fluticasone Propionate (FP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 (Forced Expiry Volume in 1 second)
Measured: FEV1 at Week 12
Secondary outcomes (1)
Peak Expiratory Flow Rate (PEFR)
Measured: PEFR at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Imtiaz Chaudry, Study director, Dey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516086
- Sponsor's protocol ID
- 191-092
- Status last verified
- Nov 2014
- First submitted
- 13 Jan 2012
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects With Partly Controlled and Uncontrolled Asthma
- ClinicalTrials.gov ID
- NCT01516086
- Acronym / sponsor ID
- 191-092
- Conditions
- Asthma
- Keywords
- Controlled, uncontrolled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Jan 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 will be a multi-center, randomized, placebo controlled parallel-group study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects with Partly Controlled and Uncontrolled Asthma. Individual participation will be approximately 16 weeks, including 12 weeks of double-blind treatment.
Detailed description
The primary outcome measure is FEV1 (Forced Expiry Volume in 1 second) and the secondary outcome measure is Peak Expiratory Flow Rate (PEFR), Asthma Control Questionnaire (ACQ), Nighttime awakenings and rescue medication usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Propionate (FP) - arm 1 | Experimental | Drug: Fluticasone Propionate (FP)FP BID (twice daily) |
| Fluticasone propionate (FP) - arm 2 | Experimental | Drug: Fluticasone Propionate (FP)FP BID |
| Fluticasone Propionate (FP) - arm 3 | Experimental | Drug: Fluticasone Propionate (FP)FP BID |
| FLuticasone Propionate (FP) - Arm 4 | Experimental | Drug: Fluticasone Propionate (FP)FP BID |
| Fluticasone Propionate (FP) - Arm 5 | Experimental | Drug: Fluticasone Propionate (FP)FP BID |
| Placebo - Arm 6 | Placebo comparator | Drug: Fluticasone Propionate (FP)Placebo inhalation solution |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- A signed and dated written informed consent form prior to the conduct of any study procedures
- Males and females between ≥ 18 and ≤ 60 years old.
- Non-smoker for at least 1 year prior to Visit 1, with a smoking history of no more than 10 pack-years (e.g., 1 pack [20 cigarettes] per day for 10 years).
- 6.Ability to understand and comply with the protocol requirements (including completion of daily PEFR, PFT and ACQ), instructions and protocol-stated restrictions.
- 7.Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit. WOCBP include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP.
Key exclusion criteria (7 listed)
- Past or present disease, excluding asthma, which as judged by the investigator, may place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives These diseases include, but are not limited to cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, diabetes type I or uncontrolled diabetes, type II, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis, COPD, eosinophilic bronchitis or pulmonary fibrosis).
- An upper or lower respiratory tract infection within 4 weeks of Visit 1 and prior to Visit 2
- A history of hypersensitivity to the study drug or its components, including albuterol as rescue medication.
- History of illegal drug or alcohol abuse within the past 5 years.
- Pregnant or lactating women.
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 |
|---|---|---|
| Fluticasone Propionate (FP)Also: No other names applicableFP Inhalation BID | Drug | FLuticasone Propionate (FP) - Arm 4, Fluticasone Propionate (FP) - Arm 5, Fluticasone Propionate (FP) - arm 1, Fluticasone Propionate (FP) - arm 3, Fluticasone propionate (FP) - arm 2, Placebo - Arm 6 |
Primary outcome
FEV1 (Forced Expiry Volume in 1 second)
Time frame: FEV1 at Week 12
1 secondary outcome
Peak Expiratory Flow Rate (PEFR)
Time frame: PEFR at Week 12
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 11 Dec 2014.
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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.
Imtiaz Chaudry study director
Dey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone Propionate (FP) in people with Asthma, run by Dey at 1 site 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 12 inclusion and 7 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 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
FEV1 (Forced Expiry Volume in 1 second) (time frame: FEV1 at Week 12). 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 11 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.