An Open Study to Assess the Robustness of the CRC749 Inhaler

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-06-30

Brief Summary

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To confirm the robustness of the CRC749 inhaler.

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Detailed Description

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Conditions

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Asthma COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MGR001

MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID)

Group Type EXPERIMENTAL

MGR001

Intervention Type DRUG

Fluticasone Propionate / Salmeterol administered using CRC749 inhaler

CRC749 inhaler

Intervention Type DEVICE

Interventions

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MGR001

Fluticasone Propionate / Salmeterol administered using CRC749 inhaler

Intervention Type DRUG

CRC749 inhaler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Males and females at least 12 years of age.
2. A clinical diagnosis for at least 12 weeks prior to screening of asthma or COPD and stable treatment.
3. Spirometry following salbutamol showing FEV1 ≥40% of predicted normal and FEV1/FVC ratio \<0.7 for COPD subjects.
4. Spirometry without salbutamol showing FEV1 ≥50% of predicted normal for asthma subjects.
5. Ability to use the CRC749 inhaler.

Exclusion Criteria

1. Other chronic or active respiratory disorder or symptoms of, or treatment for a COPD or asthma exacerbation during the 28 days preceding screening.
2. History of long QT syndrome or screening ECG with QTcF greater than 480 milliseconds.
3. Current evidence of, or history within the 6 months prior to screening of unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, or myocardial infarction.
4. Subjects in whom Advair(R) Diskus(R) / Seretide(R) Accuhaler(R) are contra-indicated.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No