Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect

Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma

Mild to Moderate Asthma Clinical Trial

Official title:
A Randomized, Placebo-controlled, Double-blind, Crossover, Single-dose Exposure Study to Evaluate the Early Bronchodilating Effect of FlutiForm 100/10 µg HFA pMDI and FlutiForm 250/10 µg HFA pMDI, Compared to Placebo in Adult Subjects With Mild to Moderate Asthma

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

See also
	Status	Clinical Trial	Phase
	Completed	`NCT02266927` - A Study to Compare the Bioavailability Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2)	Phase 1

See also

Status

Clinical Trial

Phase

Completed

NCT02266927 - A Study to Compare the Bioavailability Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2)

Phase 1

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00734292
Study type	Interventional
Source	SkyePharma AG
Contact
Status	Completed
Phase	Phase 2
Start date	September 2008
Completion date	October 2008

Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms