Fine Particle pMDI Formoterol/Beclomethasone in Asthmatics With and Without Spacer: Comparative Efficacy Evaluation

NCT01453881 | Completed Phase 3

• 1 other identifier: PTC 034/11
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate pharmacological treatment controls symptoms in most asthmatics. Pressurized metered dose inhalers (pMDI)are the most used drug delivery devices. Valved holding chambers of different types and sizes have also been developed for use in combination with pMDI. The therapeutic efficacy of treatment depends on the amount of inhaled particles. The chambers can optimize lung deposition as it obviates lung-hand coordination and retain larger particles. The aim of this study is to compare the efficacy of the fine particle combination pMDI Beclomethasone/Formoterol in asthma control,with or without the aid of a spacer in patients without adequate asthma control on medium to high-dose inhaled steroids associated with long acting beta adrenergic drugs. The hypothesis is that there is no clinical efficacy difference between the two forms of drug administration.

Conditions

Asthma

Keywords

Asthma; pMDI; Beclomethasone; Formoterol; Efficacy

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control Test Score

  The primary endpoint is the difference in the change of ACT score between groups 8 weeks after randomization compared to pre-randomization.

  8 weeks

Secondary Outcomes (1)

• Changes in Forced Expiratory Volume in the first second (FEV1)

  4 and 8 weeks

Study Arms (2)

Spacer

EXPERIMENTAL

Beclomethasone/Formoterol 100/6mcg/puff pMDI 2 puffs two times/day with the aid of a Valved Holding Chamber - VORTEX

Device: Spacer

Comparator

ACTIVE COMPARATOR

Beclomethasone/Formoterol pMDI 100/6mcg/puff pMDI 2 puffs two times/day without the aid of a Valved Holding Chamber - VORTEX

Device: Comparator

Interventions

Spacer DEVICE

Beclomethasone/Formoterol 100/6mcg pMDI 2 puffs two times/day with the aid of a Valved Holding Chamber - VORTEX

Also known as: BECLOMETHASONE EXTRA-FINE, FORMOTEROL, FOSTAIR, INNOVAIR, VORTEX

Spacer

Comparator DEVICE

Beclomethasone/Formoterol 100/6mcg pMDI 2 puffs two times/day without the aid of a Valved Holding Chamber - VORTEX

Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, age 18 to 65 years, both sexes;
• Clinical diagnosis of moderate to severe persistent asthma;
• Nonsmoker;
• Agree to participate and sign the Informed Consent;
• ACT Score \<= 19
• FEV1 \<= 80% of predicted;
• History of response to FEV1 greater than 10%;
• Patients who are already using Inhaled steroids at medium to high doses (Beclomethasone, budesonide, fluticasone) with longa-acting beta2 agonists (formoterol or salmeterol)
• Proper use of metered-dose inhaler (after orientation)

You may not qualify if:

• Patient diagnosed with Chronic Obstructive Pulmonary Disease (COPD);
• Current smokers or have stopped for less than 10 years;
• Patients with a history of recent near-fatal asthma (less than 12 months);
• Patients with a history of recent asthma hospitalization (last 6 months);
• Patients with airway infection symptoms for less than 4 weeks;
• Participation in any experimental study up to 1 (one) year from selection visit;
• Hospitalization for any reason up to 8 weeks before selection visit;
• History of liver, cardiac, renal, pulmonary or gastrointestinal diseases, epileptic, psychiatric or hematologic disorders, uncontrolled hypertension, rheumatology/orthopedic disorders that interferes with pMDI use;
• Patients unable to properly use the pMDI during the selection

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead
• Universidade Federal do vale do São Francisco: collaborator

Study Sites (1)

Hospital das Clínicas - Universidade Federal de Pernambuco

Recife, Pernambuco, 50740-520, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Metered Dose Inhalers

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• Jose A Rizzo, PhD, MD

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, Medicine Professor

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

BR (1)