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Fluticasone/Salmeterol (FP/SM) Versus Double the Dose Fluticasone (FP) in Patients With Mild to Moderate Asthma (CLE001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00830505
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : May 8, 2019
Information provided by (Responsible Party):
University of Dundee

Brief Summary:
The purpose of this study is to compare the effects of Fluticasone/ salmeterol combination and double the dose of fluticasone on airway hyper-responsiveness to methacholine in a randomised, double blind, double dummy, cross-over trial.

Condition or disease Intervention/treatment Phase
Asthma Drug: fluticasone/salmeterol Drug: fluticasone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Cross-Over Study to Demonstrate Superiority of Fluticasone/Salmeterol Over Double the Dose of Fluticasone on Methacholine Hyper-Reactivity in Patients With Persistent, Mild to Moderate Asthma
Study Start Date : April 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1: fluticasone/salmeterol
2 puffs twice a day for 2 weeks
Drug: fluticasone/salmeterol
2 puffs twice a day for 2 weeks
Other Name: fluticasone/salmeterol combination

Active Comparator: 2: fluticasone
2 puffs twice a day for 2 weeks
Drug: fluticasone
2 puffs twice a day for 2 weeks
Other Name: Flixotide

Primary Outcome Measures :
  1. methacholine challenge [ Time Frame: before and after a 2 week treatment period ]
    methacholine challenge

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Written informed consent given by patient.
  2. Male or female patients between 18 and 65 years of age inclusive.
  3. Persistent stable asthmatics (FEV1 > 60%)
  4. On ≤ 1000 µg FP or equivalent or if on combination therapy up to 500 µg of FP or equivalent (e.g. FP/SM 125 2-puffs BD or BUD/FM 200/6 2-puffs BD)
  5. Patients suffering from stable, persistent, mild to moderate asthma as defined by GINA Guidelines and for whom FEV1 > 60 %
  6. In the opinion of the investigator, able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

  1. Severe asthmatics as defined by an FEV1 < 60% or PEF variability >30% or with continual daytime or nocturnal symptoms.
  2. Known or suspected hypersensitivity to FP or any other constituents of the Test or Reference pMDI
  3. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study (such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA / CVA).
  4. Females who are pregnant, lactating or planning to become pregnant.
  5. Approximately half of the subjects will be smokers and half currently non-smokers (or who have ceased smoking at least 1 year previously).
  6. Clinically significant laboratory values, as judged by the investigator.
  7. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit.
  8. Patients who are scheduled to receive any other investigational drug during the course of the study.
  9. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
  10. Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
  11. Respiratory tract infection in the previous 2 months.
  12. Patients with significant concomitant respiratory disease such as COPD, CF, ABPA, active pulmonary TB or bronchiectesis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00830505

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United Kingdom
Asthma and Allergy Research Group
Dundee, Angus, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
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Principal Investigator: Karine L Clearie, MBBS, MRCP Asthma and Allergy Research Group
Study Director: Brian J Lipworth, MBchB Asthma and Allergy Research Group

Additional Information:
Publications of Results:
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Responsible Party: University of Dundee Identifier: NCT00830505     History of Changes
Other Study ID Numbers: CLE001
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Dundee:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists